Repositioning for treating pressure ulcers (Review) Moore ZEH, Cowman S

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 1 http://www.thecochranelibrary.com

Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS HEADER . . . . . . . . . . ABSTRACT . . . . . . . . . PLAIN LANGUAGE SUMMARY . BACKGROUND . . . . . . . OBJECTIVES . . . . . . . . METHODS . . . . . . . . . RESULTS . . . . . . . . . . DISCUSSION . . . . . . . . AUTHORS’ CONCLUSIONS . . ACKNOWLEDGEMENTS . . . REFERENCES . . . . . . . . CHARACTERISTICS OF STUDIES DATA AND ANALYSES . . . . . APPENDICES . . . . . . . . WHAT’S NEW . . . . . . . . HISTORY . . . . . . . . . . CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST . SOURCES OF SUPPORT . . . . INDEX TERMS . . . . . . .

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Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Review]

Repositioning for treating pressure ulcers Zena EH Moore1 , Seamus Cowman2 1 School

of Nursing & Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland. 2 Faculty of Nursing and Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland Contact address: Zena EH Moore, School of Nursing & Midwifery, Royal College of Surgeons in Ireland, 123 St. Stephen’s Green, Dublin, D2, Ireland. [email protected]. Editorial group: Cochrane Wounds Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 1, 2015. Review content assessed as up-to-date: 28 August 2014. Citation: Moore ZEH, Cowman S. Repositioning for treating pressure ulcers. Cochrane Database of Systematic Reviews 2015, Issue 1. Art. No.: CD006898. DOI: 10.1002/14651858.CD006898.pub4. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background Pressure, from lying or sitting on a particular part of the body results in reduced oxygen and nutrient supply, impaired drainage of waste products and damage to cells. If a patient with an existing pressure ulcer continues to lie or bear weight on the affected area, the tissues become depleted of blood flow and there is no oxygen or nutrient supply to the wound, and no removal of waste products from the wound, all of which are necessary for healing. Patients who cannot reposition themselves require assistance. International best practice advocates the use of repositioning as an integral component of a pressure ulcer management strategy. This review has been conducted to clarify the role of repositioning in the management of patients with pressure ulcers. Objectives To assess the effects of repositioning patients on the healing rates of pressure ulcers. Search methods For this third update we searched the Cochrane Wounds Group Specialised Register (searched 28 August 2014); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 7); Ovid MEDLINE (2013 to August Week 3 2014); Ovid MEDLINE (In-Process & Other Non-Indexed Citations 29 August, 2014); Ovid EMBASE (2012 to 29 August, 2014); and EBSCO CINAHL (2012 to 27 August 2014). Selection criteria We considered randomised controlled trials (RCTs) comparing repositioning with no repositioning, or RCTs comparing different repositioning techniques, or RCTs comparing different repositioning frequencies for the review. Controlled clinical trials (CCTs) were only to be considered in the absence of RCTs. Data collection and analysis Two authors independently assessed titles and, where available, abstracts of the studies identified by the search strategy for their eligibility. We obtained full versions of potentially relevant studies and two authors independently screened these against the inclusion criteria. Main results We identified no studies that met the inclusion criteria. Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors’ conclusions Despite the widespread use of repositioning as a component of the management plan for individuals with existing pressure ulcers, no randomised trials exist that assess the effects of repositioning patients on the healing rates of pressure ulcers. Therefore, we cannot conclude whether repositioning patients improves the healing rates of pressure ulcers. The effect of repositioning on pressure ulcer healing needs to be evaluated.

PLAIN LANGUAGE SUMMARY Repositioning for treating pressure ulcers Pressure ulcers (also known as bed sores, pressure sores and decubitus ulcers) are localised areas of tissue damage caused by excess pressure and shearing forces. Pressure ulcers mainly occur in people who have limited mobility, nerve damage or both. Pressure, from lying or sitting on a particular part of the body, results in oxygen and nutrient deprivation to the affected area. Repositioning involves moving the individual into a different position in order to remove or redistribute pressure from a part of the body. If a person with an existing pressure ulcer continues to lie or bear weight on the affected area, the tissues become depleted of blood flow and there is no oxygen or nutrient supply to the wound, and no removal of waste products from the wound, all of which are necessary for healing. People who cannot reposition themselves require assistance. International best practice advocates the use of repositioning as an integral component of a pressure ulcer management strategy. The authors of this review found no studies that were eligible for inclusion in the review. Therefore, we do not know whether repositioning people makes any difference to the healing rates of pressure ulcers.

BACKGROUND

Description of the condition A pressure ulcer is defined as localised injury to the skin, underlying tissue or both, usually over a bony prominence, as a result of pressure, or pressure in combination with shear. A number of contributing or confounding factors are also associated with pressure ulcers; the significance of these factors is yet to be elucidated (EPUAP/NPUAP 2009). Because exposure to sustained mechanical loading is the prime factor contributing to pressure ulcer development, they commonly occur in people who do not have the ability to reposition themselves in order to relieve pressure (Moore 2011). Those most at risk are the very old, the malnourished and those with acute illness (Wann-Hanson 2008). Pressure ulcer prevalence and incidence figures differ depending on the method of data collection and the classification used. Prevalence rates fluctuate from 8.8% to 53.2% (Gallagher 2008; Moore 2012) and incidence rates vary from 7% to 71.6% (Moore 2011; Scott 2006; Whittington 2004). The most common anatomical sites for pressure ulcers to occur are the sacrum and the heels, and the majority are grade 1 or grade 2 in severity (Gallagher 2008; Gethin 2005; Moore 2000; Moore 2011) Pressure ulcers have a negative impact on quality of life; it is known that individuals with pressure ulcers frequently experience pain

combined with fear, isolation and anxiety regarding wound healing (Hopkins 2006; Gorecki 2009; Spilsbury 2007). Pressure ulcers are also associated with increased mortality (Kroger 2008). Whether this relates to the fact that pressure ulcers occur in a population that is for the most part debilitated, with a high incidence of co-morbidities, or whether it relates to the presence of a pressure ulcer alone, remains unclear (Brown 2003). However, the evidence suggests an almost two-fold increase in death among those with pressure ulcers when compared to their matched counterparts without pressure ulcers (Landi 2007) Pressure ulcers are a significant financial burden to healthcare systems. Bennett 2004 suggested that the total annual cost for pressure ulcer management in the UK is £1.4 to £2.1 billion (UKPound), which at that time was equivalent to 4% of the total UK healthcare expenditure. Similar findings have been noted in the Netherlands, where pressure ulcers have been found to be the third most expensive health problem (Haalboom 2000). More recently, Dealey 2012 notes that the cost of treating pressure ulcers relates to the severity of the wound, with costs increasing from £1,214 for a grade 1 pressure ulcer, to £14,108 for a grade 4 pressure ulcer. Furthermore, it has been shown that older persons with pressure ulcers have a longer overall hospital stay and a higher excess length of stay compared with similar cases without a pressure ulcer (Theisen 2012). Globally, the exact economic impact of pressure ulcers has yet to be

Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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established, however it is known that pressure ulcers are common (Moore 2012) and affect patients in both community (Margolis 2002) and hospital settings (Gallagher 2008). Although individuals of any age can develop pressure ulcers, they are more common in groups of people such as the elderly (Moore 2012) and those in orthopaedic settings (Remaley 2010), though other medical conditions can predispose individuals to their development (Schoonhoven 2002). Changing demographics, and the rise in the number of elderly in the future, mean that the number of pressure ulcers is likely to increase in the years ahead. Therefore, it is reasonable to expect that treatment strategies that reduce the impact of pressure ulcers will have a positive impact on patients and the health service as a whole (Dealey 2012).

quire assistance. International best practice advocates the use of repositioning as an integral component of a pressure ulcer management strategy. Although repositioning is advocated, confusion exists about the frequency and exact method of repositioning required: the Agency for Health Care Policy and Research, USA advocates two-hourly repositioning (AHCPR 1992), whereas the European Pressure Ulcer Advisory Panel & National Pressure Ulcer Advisory Panel and the National Institute for Clinical Excellence, UK advocate repositioning as required by the individual patient (EPUAP/NPUAP 2009; NICE 2005). This lack of unity necessitated a systematic review of the literature to summarise the current evidence. The review may provide a contribution to relevant clinical guidelines. In addition, the review informs research in this important area of patient care.

Description of the intervention Wound healing is a normal response to injury. It is initiated after the skin’s integrity has been interrupted, for example, by the development of a pressure ulcer (Martin 1997). The purpose of the healing process is to replace the tissue that has been damaged, with living tissue, and to restore the continuity of the skin (Tarnuzzer 1996). Open wounds, including pressure ulcers, heal through formation of granulation tissue and epithelialisation (Slavin 1996). Granulation tissue is characterised by a high density of blood vessels, capillaries and many different cells, so the metabolic need of the wounded area is great (Krishnamoothy 2001). Normal cellular metabolism requires an adequate supply of oxygen and nutrients, and also an effective elimination of waste metabolites (Kosiak 1966). Sustained unrelieved pressure causes vascular obstruction that eliminates capillary blood flow to an area (Kosiak 1959), causing oxygen and nutrient deprivation there (Husain 1953). Since the cells necessary for wound healing cannot proliferate in such an environment, wound healing is impaired (Kosiak 1966). Certain positioning techniques, for example, 90-degree lateral rotation, which is used during bed rest, may exacerbate this situation and cause complete anoxia (lack of oxygen) to the weight-bearing area (Colin 1996; Sache 1998; Seiler 1986). Since it is possible that a patient may be positioned directly onto a pressure ulcer, especially when multiple ulcers are present, the impact that this may have on wound healing is an important consideration. The management of people with pressure ulcers involves numerous different interventions including nutritional care (EPUAP 2003; Langer 2003), pressure reducing/relieving surfaces (McInnes 2004; McInnes 2008), and skin and wound care (Butcher 2009; Moore 2005). Repositioning people is also an important component in the management of pressure ulcers (Moore 2012). Pressure, from lying or sitting on a particular part of the body, results in oxygen deprivation to the affected area (Defloor 2005). This normally results in pain and discomfort which stimulates the individual to move. Failure to reposition will result in ongoing oxygen deprivation, poor wound healing and further tissue damage (Defloor 2005). People who cannot reposition themselves re-

OBJECTIVES To assess the effects of repositioning people on the healing rates of pressure ulcers.

METHODS

Criteria for considering studies for this review

Types of studies We considered randomised controlled trials (RCTs) comparing repositioning with no repositioning, or RCTs comparing different repositioning techniques, or RCTs comparing different repositioning frequencies for the review. Controlled clinical trials (CCTs) were only to be considered in the absence of RCTs.

Types of participants Studies involving people of any age, in any healthcare setting, with existing pressure ulcers (defined as a break in the continuity of the skin caused by pressure, shearing or friction forces (Nixon 1999)).

Types of interventions Studies describing the following comparisons were eligible for the review. 1. Repositioning compared with no repositioning. 2. Comparisons between different frequencies of repositioning. 3. Comparisons between different positions for repositioning (e.g. 90-degree lateral rotation, 30-degree tilt).

Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Types of outcome measures

• Procedural pain. • Assessment of quality of life (using validated scales, where reported). • Ease of use of the method of repositioning. • Adverse events such as falls, length of hospital stay or death.

#6 MeSH descriptor Posture explode all trees #7(reposition* or re-position*) #8 mobilis* or mobiliz* #9 turn* NEAR/5 patient* #10 turn* NEAR/5 interval* #11 turn* NEAR/5 frequen* #12 (#7 OR #8 OR #9 OR #10 OR #11) #13 (#5 AND #12) The search strategies for Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL can be found in Appendix 2, Appendix 3 and Appendix 4 respectively. The MEDLINE search was combined with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity- and precision-maximizing version (2008 revision); Ovid format (Lefebvre 2011). The EMBASE and CINAHL searches were combined with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN) (SIGN 2011). There were no restrictions on articles on the basis of language, date of publication or publication status.

We planned to report secondary outcomes only from studies that also reported the primary outcomes.

Searching other resources

Primary outcomes

We considered trials if they reported at least one of the primary outcomes. The primary outcomes were objective measures of pressure ulcer healing and included: time to complete healing; absolute or percentage change in pressure ulcer area or volume over time; proportion of pressure ulcers healed at the completion of the trial period; or healing rate.

Secondary outcomes

Search methods for identification of studies

Electronic searches The electronic search methods for the second update of this review can be found in Appendix 1 For this update we searched the following databases: • The Cochrane Wounds Group Specialised Register (searched 28 August 2014); • The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 7); • The Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library 2014, Issue 3); • The Health Technology Assessment Database (HTA) (The Cochrane Library 2014, Issue 3); • The NHS Economic Evaluation Database (NHS EED) (The Cochrane Library 2014, Issue 3); • Ovid MEDLINE (2012 to August Week 3 2014); • Ovid MEDLINE (In-Process & Other Non-Indexed Citations 29 August, 2014); • Ovid EMBASE (2012 to 29 August, 2014); • EBSCO CINAHL (1982 to 27 August 2014) We used the following search strategy in The Cochrane Central Register of Controlled Trials (CENTRAL): #1 MeSH descriptor Pressure Ulcer explode all trees #2 pressure NEXT (ulcer* or sore*) #3 decubitus NEXT (ulcer* or sore*) #4 (bed NEXT sore*) or bedsore* #5 (#1 OR #2 OR #3 OR #4)

For the original version of this review we scanned the bibliographies of all retrieved and relevant publications identified by these strategies for further studies. We contacted experts in the wound care field, namely council members of the European Pressure Ulcer Advisory Panel, The European Wound Management Association, The National Pressure Ulcer Advisory Panel and the World Union of Wound Healing Societies, and searched conference proceedings and grey literature to identify any studies that were not located through the primary search.

Data collection and analysis

Selection of studies Two review authors independently assessed titles and, where available, abstracts of the studies identified by the search strategy for their eligibility for inclusion in the review (as described in ’Criteria for considering studies for this review’). We obtained full versions of potentially relevant studies and two review authors independently screened these against the inclusion criteria. We resolved any differences in opinion by discussion. Data extraction and management We planned to extract and summarise details of eligible studies using a data extraction sheet. Specifically, the following information was to be extracted: • author; • title; • source;

Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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• • • • • • • • • • • • • • • • •

date of study; country; care setting; inclusion/exclusion criteria; sample size; patient characteristics by treatment group; design details; study type; allocation method; intervention details by treatment group; concurrent interventions; length of follow up; outcome measures; analysis; loss to follow up; results; method of outcome measurement.

Two review authors were to extract data independently; any differences in opinion was to be resolved by discussion and, where necessary, reference to the Wounds Group editorial base. If data were missing from reports, we intended to make attempts to contact study authors to obtain the missing information.

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0% to 50%). If there was evidence of heterogeneity (values of I2 over 50%) we planned to use a random-effects model. If pooling was not appropriate, we planned to present the studies in a narrative summary only. Results were to be presented by care setting and patient group.

Data synthesis We planned to conduct a structured narrative summary of the studies reviewed initially. For dichotomous outcomes, we were to calculate risk ratio (RR) plus 95% confidence interval (CI). For continuous outcomes, we were to calculate mean difference (MD) plus 95% CI.

Sensitivity analysis We planned to include all eligible trials in the initial analysis and to carry out sensitivity analyses to evaluate the effect of trial risk of bias. This was to be done by excluding trials most susceptible to bias based on the quality assessment: those with inadequate allocation concealment, high levels of post randomisation losses or exclusions, and uncertain or unblinded outcome assessment.

Assessment of risk of bias in included studies The quality of studies was to be assessed independently by two authors, without blinding to journal or authorship, using the Cochrane Collaboration tool for assessing risk of bias (Higgins 2011). This tool addresses six specific domains, namely sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other issues (e.g. extreme baseline imbalance) (see Appendix 1 for details of the criteria on which the judgements are based). We planned to assess blinding and completeness of outcome data for each outcome separately. We planned to complete a ’Risk of bias’ table for each eligible study. We would have discussed any disagreement amongst all authors to achieve a consensus. We planned to present assessment of risk of bias using a ’Risk of bias’ summary figure, which presents all of the judgments in a cross-tabulation of study by entry. This display of internal validity indicates the weight the reader may give the results of each study.

RESULTS

Description of studies The searches identified 362 citations in total. Following independent review of the titles and abstracts of the citations by two review authors, no papers met the inclusion criteria. Nor did any papers appear to potentially meet the inclusion criteria and therefore there were no studies added to the Characteristics of excluded studies table. We wrote 55 letters to wound care experts; 12 replies were received, yielding a response rate of 21%. We identified no further trials through this process. For this update we identified on potential study (Groah 2011), however, having read the full paper, it was evident that the paper was reporting on the plan to conduct a study, which has not as yet been conducted (see Characteristics of excluded studies). Therefore, no studies, RCTs or CCTs, met the inclusion criteria

Assessment of heterogeneity We planned to explore clinical heterogeneity by examining potentially influential factors, e.g. care setting or patient characteristics. Statistical heterogeneity was to be assessed using the I2 statistic (Higgins 2003). This examines the percentage of total variation across studies due to heterogeneity rather than chance. Values of I2 over 75% indicate a high level of heterogeneity. If there were sufficiently similar studies to consider pooling, we planned to use a fixed-effect model for low to moderate levels of heterogeneity (I

Risk of bias in included studies We identified no eligible studies (RCTs or CCTs).

Effects of interventions We identified no eligible studies (RCTs or CCTs).

Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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DISCUSSION We identified no eligible studies despite our having made every attempt to identify all relevant studies, including contacting experts in this field and searching conference proceedings to identify studies as yet unpublished. It is theoretically possible, though unlikely, that we did not manage to locate some potentially eligible studies. In line with Cochrane policy, we will continue to undertake updates of this review and any studies identified at that stage which meet the inclusion criteria will be included. In order to maintain health, tissues require an adequate supply of oxygen and nutrients (Gottrup 2004). Pressure from lying or sitting on a particular part of the body results in oxygen deprivation to the affected area (Defloor 2005). There are normally a number of stimulators, during sleep and whilst awake, that motivate the individual to move (Krapfl 2008). Failure to reposition will result in ongoing oxygen deprivation and inevitable tissue damage (Defloor 2005), because of ongoing occlusion of blood supply to the affected area (Husain 1953). Repositioning is advocated as one of the interventions needed for the management of pressure ulcers and involves moving the individual into a different position in order to remove or redistribute pressure from a particular part of the body (Krapfl 2008). The two concerns are firstly, the individual’s ability to feel pain and secondly, the individual’s actual physical ability to move or to reposition themselves (Defloor 2005). In the absence of the patient having the ability to reposition, they require assistance (AHCPR 1992; EPUAP/NPUAP 2009; NICE 2005). Wound healing is a normal response to injury and is initiated following interruption of the skins integrity. The purpose of this process is to replace the damaged tissue with living tissue and to restore the continuity of the skin. This occurs as a result of a finely balanced sequence of events, which are regulated by growth factors, cytokines and matrix metalloproteinases (Tarnuzzer 1996). Open wounds, including pressure ulcers, heal through formation of granulation tissue and epithelialisation (Slavin 1996). Granulation tissue is characterised by a high density of blood vessels, capillaries and many different cells, so the metabolic need of the wounded area is great (Krishnamoothy 2001). Wound healing normally follows a logical pattern, however, for many people this process is adversely influenced by a number of factors, for example, infection, poor blood supply or systemic disease (Tarnuzzer 1996). Wound healing potential is influenced by the perfusion of the affected area (Gottrup 2004; Kosiak 1959; LaVan 1990). Sustained unrelieved pressure causes vascular obstruction that eliminates capillary blood flow to an area (Kosiak 1959), causing oxygen and nutrient deprivation there (Husain 1953). Certain positioning techniques, for example 90-degree lateral rotation, which is used during bed rest, may exacerbate this situation and cause complete anoxia (lack of oxygen) to the weight-bearing area (Colin 1996; Sache 1998; Seiler 1986). It is possible that a patient may be positioned directly onto a pressure ulcer - especially when multiple ulcers are present. If a patient with an existing pressure ulcer con-

tinues to lie or bear weight on the affected area, the tissues will be depleted of blood flow and will therefore remain without oxygen supply (Kosiak 1959). Depleted blood flow also means that the nutrients required for wound healing will not be made available to the wound and the removal of waste products from the wound will be impaired (Kosiak 1959). The overall result of this is that the wound will not heal and that, furthermore, the patient will be at risk of developing further tissue damage (Allman 1997; Krapfl 2008). A fundamental way in which nurses and care staff may contribute to maximising the healing potential of existing pressure ulcers is by repositioning those patients who are unable to reposition themselves. International best practice advocates the use of repositioning as an integral component of a pressure ulcer prevention and management strategy. Although repositioning is advocated, there remains little scientific evidence upon which to base clinical decisions. Confusion exists regarding the frequency of turning required, with the Agency for Health Care Policy and Research, USA (AHCPR 1992) advocating two-hourly turns, while the European Pressure Ulcer Advisory Panel & National Pressure Ulcer Advisory Panel (EPUAP/NPUAP 2009) and the National Institute for Clinical Evidence, UK (NICE 2005) advocate turning as required by the individual patient. Indeed, the Agency for Health Research and Quality, USA (AHCPR 1992) acknowledges that whereas repositioning is a practice with good face validity, no welldesigned controlled trials have examined its effect. Overall, there is a lack of randomised controlled trial (RCT) evidence available. Repositioning continues to play a central role in the management of those individuals with existing pressure ulcers. Repositioning is not a novel concept, indeed it has been discussed in the literature for many decades and as far back as 1848, Robert Graves first described how pressure ulcers could be prevented, and managed more effectively, through the use of repositioning (Sebastian 2000). It is interesting that even today the question of whether repositioning makes any difference to pressure ulcer healing has yet to be researched in a methodologically sound manner. However, despite this, repositioning continues to be advocated as part of pressure ulcer prevention and management strategies.

AUTHORS’ CONCLUSIONS Implications for practice There is no randomised controlled trial (RCT) evidence that addresses the question of whether repositioning patients improves the healing rates of pressure ulcers. Although repositioning is a practice with good face value, there is no available RCT evidence to provide specific guidance for practice. Weight bearing directly onto an existing pressure ulcer will cause vascular obstruction which will eliminate capillary blood flow to the pressure ulcer. Therefore, it is reasonable to suggest that individuals with pressure ulcers are

Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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repositioned to avoid depriving the wounded area of oxygen and nutrients which are needed for tissue repair.

Repositioning trials need to consider the effects of the following on the healing rates of pressure ulcers: • The effects of different repositioning regimes, for example, the 30 degree tilt versus the 90 degree lateral rotation.

Implications for research Repositioning is an integral component of pressure ulcer management strategies and is widely utilised in clinical practice. To date, there is no RCT evidence available to identify whether repositioning makes any difference to the healing rates of pressure ulcers. There is a need for a large cluster-randomised study, correctly powered, with treatment groups comparable at baseline, allocation to groups concealed, blinded outcome assessment and intention-totreat analysis, to confirm the role of repositioning in the healing of pressure ulcers. Cluster randomisation involves the randomisation of units rather than individuals to the different arms of a study, for example units within a hospital, rather than individual patients (MRC 2002). Cluster randomised trials are used for a number of reasons; increased efficiency, increased compliance with the study protocol and avoidance of contamination (Donner 2004). Contamination is said to occur when an intervention is given to an individual but may affect others within the trial (Puffer 2005). For example, in a repositioning trial, care staff using a specific repositioning regime (e.g. the 30 degree tilt) may find it more practical to administer the intervention to all those who meet the inclusion criteria in a specific unit, rather than administer different repositioning regimes to different patients within the same unit.

• The effects of different frequencies of repositioning, for example, 2 hourly turning, 3 hourly turning, 4 hourly turning etc. • The effects of different repositioning regimes, in combination with a pressure redistribution mattress. • The effects of different frequencies of repositioning, in combination with pressure redistribution mattress.

ACKNOWLEDGEMENTS The authors would like to acknowledge the peer referees (AnneMarie Bagnall, Sheila Benton-Jones, Carol Dealey, Liz McGinnis) and the Wounds Group Editors (Mieke Flour, Liz McInnes, Gill Worthy) for their feedback on the protocol and review. In addition, thanks to Jenny Bellorini, Cochrane Copy Editor, Ruth Foxlee, Trial Search Coordinator, for her advice and input on the search strategy and to Sally Bell-Syer, Review Group Coordinator, for her support, advice and guidance at all stages of the development of this review.

REFERENCES

References to studies excluded from this review Groah 2011 {published data only} Groah SL, Ramella-Roman J, Libin A, Schladen MM, Lichy A. Skin microvascular and metabolic response to sitting and pressure relief maneuvers in people with spinal cord injury. Topics in Spinal Cord Injury Rehabilitation 2011;16 (3):33–45.

Additional references AHCPR 1992 Agency for Health Care Policy and Research. Pressure ulcers in adults: prediction and prevention.. Clinical practice guideline number 3. Rockville MD: Public Health Service, US, Department of Health and Human Services, 1992.

Brown 2003 Brown G. Long-term outcomes of full-thickness pressure ulcers: healing and mortality. Ostomy/Wound Management 2003;49(10):42–50. Butcher 2009 Butcher M, Thompson G. Dressings can prevent pressure ulcers: fact or fallacy? The problem of pressure ulcer prevention. Wounds UK 2009;5(4):80–93. Colin 1996 Colin D, Abraham P, Preault L, Bregeon C, Saumet JL. Comparison of 90 degree and 30 degree laterally inclined positions in the prevention of pressure ulcers using transcutaneous oxygen and carbon dioxide pressures. Advances in Wound Care 1996;9(3):35–8.

Allman 1997 Allman RM. Pressure ulcer prevalence, incidence, risk factors and impact. Clinical Geriatric Medicine 1997;13: 421–6.

Dealey 2012 Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. Journal of Wound Care 2012;21 (6):261–6.

Bennett 2004 Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age and Ageing 2004;33(3):230–5.

Defloor 2005 Defloor T, De Bacquer D, Grypdonck MH. The effect of various combinations of turning and pressure reducing

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devices on the incidence of pressure ulcers. International Journal of Nursing Studies 2005;42(1):37–46. Donner 2004 Donner A, Klar A.R.N. Pitfalls of and controversies in cluster randomization trials. American Journal of Public Health 2004;94:416–22. EPUAP 2003 European Pressure Ulcer Advisory Panel. EPUAP guidelines on the role of nutrition in pressure ulcer prevention and management. EPUAP Review 2003;5(2):50–63. EPUAP/NPUAP 2009 European Pressure Advisory Panel and National Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Washington DC: National Pressure Ulcer Advisory Panel, 2009.

Husain 1953 Husain T. An experimental study of some pressure effects on tissues with reference to the bed-sore problem. Journal of Pathology Bacteriology 1953;66:347–56. Kosiak 1959 Kosiak M. Etiology and pathology of ischaemic ulcers. Archives of Physical Medicine and Rehabilitation 1959;40: 62–9. Kosiak 1966 Kosiak M. An effective method of preventing decubital ulcers. Archives of Physical Medicine and Rehabilitation 1966;47(11):724–9. Krapfl 2008 Krapfl L, Gray M. Does regular repositioning prevent pressure ulcers?. Journal of Wound, Ostomy and Continence Nursing 2008;36(6):571–7.

Gallagher 2008 Gallagher P, Barry P, Hartigan I, McCluskey P, O’Connor K, O’Connor M. Prevalence of pressure ulcers in three university teaching hospitals in Ireland. Journal of Tissue Viability 2008;17:103–9.

Krishnamoothy 2001 Krishnamoorthy L, Morris HL, Harding KG. A dynamic regulator: the role of growth factors in tissue repair. Journal of Wound Care 2001;10(4):99–101.

Gethin 2005 Gethin G, Jordan O Brien J, Moore Z. Estimating costs of pressure area management based on a survey of ulcer care in one Irish hospital. Journal of Wound Care 2005;14:162–5.

Kroger 2008 Kröger K, Niebel W, Maier I, Stausberg J, Gerber V, Schwarzkopf A. Prevalence of Pressure Ulcers in Hospitalized Patients in Germany in 2005: Data from the Federal Statistical Office. Gerontology 2008;55:281–7.

Gorecki 2009 Gorecki C, Brown JM, Nelson EA, Briggs M, Schoonhoven L, Dealey C, Defloor T, Nixon J, European Quality of Life Pressure Ulcer Project group. Impact of pressure ulcers on quality of life in older patients: a systematic review. Journal of the American Geriatric Society 2009;57(7):1175–83. Gottrup 2004 Gottrup F. Oxygen in wound healing and infection. World Journal of Surgery 2004;28(3):312–5. Haalboom 2000 Haalboom JR. The Dutch experience of pressure ulcers: a personal view. Journal of Wound Care 2000;9(3):121–2. Higgins 2003 Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327 (7414):557–60. Higgins 2011 Higgins JPT, Altman DG, on behalf of the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.. Hopkins 2006 Hopkins A, Dealey C, Bale S, Defloor T, Worboys F. Patient stories of living with a pressure ulcer. Journal of Advanced Nursing 2006;56(4):345–53.

Landi 2007 Landi F, Onder G, Russo A, Bernabei R. Pressure ulcer and mortality in frail elderly people living in the community. Archives of Gerontological Geriatrics 2007;44:217–23. Langer 2003 Langer G, Kuss O, Fink A. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database of Systematic Reviews 2003, Issue 4. [DOI: 10.1002/ 14651858.CD003216] LaVan 1990 LaVan FB, Hunt TK. Oxygen and wound healing. Clinical Plastic Surgery 1990;17(3):463–72. Lefebvre 2011 Lefebvre C, Manheimer E, Glanville J, on behalf of the Cochrane Information Retrieval Methods Group. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org. Margolis 2002 Margolis DJ, Bilker W, Knauss J, Baumgarten M, Strom BL. The incidence and prevalence of pressure ulcers among elderly patients in general medical practice. Annals of Epidemiology 2002;12:321–5. Martin 1997 Martin P. Wound healing - aiming for perfect skin regeneration. Science 1997;276:75–81.

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McInnes 2004 McInnes E. The use of pressure relieving devices (beds, mattresses and overlays) for the prevention of pressure ulcers in primary and secondary care. Journal of Tissue Viability 2004;14(1):4–10. McInnes 2008 McInnes E, Bell-Syer SEM, Dumville JC, Legood R, Cullum NA. Support surfaces for pressure ulcer prevention. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD001735.pub4] Moore 2000 Moore Z, Pitman S. Towards establishing a pressure sore prevention and management policy in an acute hospital setting. The All Ireland Journal of Nursing and Midwifery 2000;1:7–11. Moore 2005 Moore ZEH, Cowman S. Wound cleansing for pressure ulcers. Cochrane Database of Systematic Reviews 2005, Issue 4. [DOI: 10.1002/14651858.CD004983.pub2] Moore 2011 Moore Z, Cowman S, Conroy RM. A randomised controlled clinical trial of repositioning, using the 30° tilt, for the prevention of pressure ulcers. Journal of Clinical Nursing 2011;20:2633–44. Moore 2012 Moore Z, Cowman S. Pressure ulcer prevalence and prevention practices in care of the older person in the Republic of Ireland. Journal of Clinical Nursing 2012;21: 362–71. MRC 2002 Medical Research Council. Cluster randomised trials: methodological and ethical issues. London: Medical Research Council, 2002. NICE 2005 National Institute for Health and Clinical Excellence. The management of pressure ulcers in primary and secondary care. Clinical Guideline Number 29. London, UK, 2005: 1–245. Nixon 1999 Nixon J, Smye S, Scott J, Bond S. The diagnosis of early pressure sores: report of the pilot study. Journal of Tissue Viability 1999;9:62–6. Puffer 2005 Puffer S, Torgerson D.J, Watson J. Cluster randomized controlled trials. Journal of Evaluation in Clinical Practice 2005;11:479–83. Remaley 2010 Remaley DT, Jaeblon DO. Pressure Ulcers in Orthopaedics. Journal of the American Academy of Orthopaedic Surgeons 2010;18(9):568–75. Sache 1998 Sache RE, Fink SA, Klitzman B. Comparison of supine and lateral positioning on various clinically used support surfaces. Annals of Plastic Surgery 1998;41:513–8.

Schoonhoven 2002 Schoonhoven L, Defloor T, Grypdonck HHF. Incidence of pressure ulcers due to surgery. Journal of Clinical Nursing 2002;11:479–87. Scott 2006 Scott JR, Gibran NS, Engrav LH, Mack CD, Rivara FP. Incidence and characteristics of hospitalized patients with pressure ulcers: State of Washington, 1987 to 2000. Plastic Reconstructive Surgery 2006;117:630–4. Sebastian 2000 Sebastian A. Robert Graves (1796-1853). A Dictionary of the History of Medicine. New York: Partenon Publishing Group, 2000. Seiler 1986 Seiler WO, Allen S, Stahelin HB. Influence of the 30 degree laterally inclined position and the super-soft 3-piece mattress on skin oxygen tension on areas of maximum pressure implications for pressure sore prevention. Gerontology 1986; 32:158–66. SIGN 2011 Scottish Intercollegiate Guidelines Network (SIGN). Search filters. http://www.sign.ac.uk/methodology/filters.html# random 2011. Slavin 1996 Slavin J. The role of cytokines in wound healing. Journal of Pathology 1996;178:5–10. Spilsbury 2007 Spilsbury K, Nelson A, Cullum N, Iglesias C, Nixon J, Mason S. Pressure ulcers and their treatment and effects on quality of life: hospital inpatient perspectives. Journal of Advanced Nursing 2007;57:494–504. Tarnuzzer 1996 Tarnuzzer RW, Schultz GS. Biochemical analysis of acute and chronic wound environments. Wound Repair and Regeneration 1996;4(3):321–5. Theisen 2012 Theisen S, Drabik A, Stock S. Pressure ulcers in older hospitalised patients and its impact on length of stay: a retrospective observational study. Journal of Clinical Nursing 2012;21(3-4):380–7. Wann-Hanson 2008 Wann-Hansson C, Hagell P, Willman A. Risk factors and prevention among patients with hospital-acquired and preexisting pressure ulcers in an acute care hospital. Journal of Clinical Nursing 2008;17:1718–27. Whittington 2004 Whittington KT, Briones R. National Prevalence and Incidence Study: 6-year sequential acute care data. Advances in Skin and Wound Care 2004;17(9):490–4.

References to other published versions of this review Moore 2010 Moore Z, Cowan S. Systematic review of repositioning for the treatment of pressure ulcers. EWMA Journal 2010;10 (1):5–12.

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Indicates the major publication for the study

CHARACTERISTICS OF STUDIES

Characteristics of excluded studies [ordered by year of study]

Study

Reason for exclusion

Groah 2011

Paper reports on the plan to conduct a study on repositioning, the study has not yet been undertaken

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DATA AND ANALYSES This review has no analyses.

APPENDICES Appendix 1. Search methods - second update 2012 For this second update we searched the following databases: • Cochrane Wounds Group Specialised Register (searched 23 May 2012); • The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 5); • Ovid MEDLINE (2010 to May Week 2 2012); • Ovid MEDLINE (In-Process & Other Non-Indexed Citations May 22, 2012); • Ovid EMBASE (2010 to 2012 Week 20); • EBSCO CINAHL (2010 to 16 May 2012). We used the following search strategy in The Cochrane Central Register of Controlled Trials (CENTRAL): #1 MeSH descriptor Pressure Ulcer explode all trees #2 pressure NEXT (ulcer* or sore*) #3 decubitus NEXT (ulcer* or sore*) #4 (bed NEXT sore*) or bedsore* #5 (#1 OR #2 OR #3 OR #4) #6 MeSH descriptor Posture explode all trees #7(reposition* or re-position*) #8 mobilis* or mobiliz* #9 turn* NEAR/5 patient* #10 turn* NEAR/5 interval* #11 turn* NEAR/5 frequen* #12 (#7 OR #8 OR #9 OR #10 OR #11) #13 (#5 AND #12) The search strategies for Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL can be found in Appendix 2, Appendix 3 and Appendix 4 respectively. The MEDLINE search was combined with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity- and precision-maximizing version (2008 revision); Ovid format. The EMBASE and CINAHL searches were combined with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN). No language restrictions were applied.

Appendix 2. Ovid MEDLINE search strategy 1 exp Pressure Ulcer/ 2 (pressure adj (ulcer$ or sore$)).mp. 3 (decubitus adj (ulcer$ or sore$)).mp. 4 (bedsore$ or (bed adj sore$)).mp. 5 or/1-4 6 exp Posture/ 7 (reposition$ or re-position$).mp. 8 (mobilis$ or mobiliz$).mp. 9 (turn$ adj5 patient$).mp. 10 (turn$ adj5 interval$).mp. 11 (turn$ adj5 frequen$).mp. Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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12 or/6-11

Appendix 3. Ovid EMBASE search strategy 1 exp Decubitus/ 2 (pressure adj (ulcer$ or sore$)).ti,ab. 3 (decubitus adj (ulcer$ or sore$)).ti,ab. 4 (bedsore$ or (bed adj sore$)).ti,ab. 5 or/1-4 6 exp patient positioning/ 7 (reposition$ or re-position$).ti,ab. 8 exp Mobilization/ 9 (mobilis$ or mobiliz$).ti,ab. 10 (turn$ adj5 patient$).mp. 11 (turn$ adj5 interval$).mp. 12 (turn$ adj5 frequen$).mp. 13 or/6-12 14 5 and 13

Appendix 4. EBSCO CINAHL search strategy S13 S12 and S5 S12 S11 or S10 or S9 or S8 or S7 or S6 S11 turn* N5 frequen* S10 turn* N5 interval* S9 turn* N5 patient* S8 mobilis* or mobiliz* S7 reposition* or re-position* S6 (MH “Patient Positioning+”) S5 S4 or S3 or S2 or S1 S4 bedsore* or bed N1 sore* S3 decubitus ulcer* or decubitus sore* S2 pressure ulcer* or pressure sore* S1 (MH “Pressure Ulcer”)

Appendix 5. Risk of bias definitions

1. Was the allocation sequence randomly generated?

Low risk of bias The investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots. High risk of bias The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.

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Unclear Insufficient information about the sequence generation process to permit judgement of low or high risk of bias.

2. Was the treatment allocation adequately concealed?

Low risk of bias Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomisation); sequentially-numbered drug containers of identical appearance; sequentially-numbered, opaque, sealed envelopes.

High risk of bias Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.

Unclear Insufficient information to permit judgement of low or high risk of bias. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.

3. Blinding - was knowledge of the allocated interventions adequately prevented during the study?

Low risk of bias Any one of the following. • No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding. • Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken. • Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non-blinding of others unlikely to introduce bias.

High risk of bias Any one of the following. • No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding. • Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken. • Either participants or some key study personnel were not blinded, and the non-blinding of others likely to introduce bias.

Unclear Any one of the following. • Insufficient information to permit judgement of low or high risk of bias. • The study did not address this outcome.

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4. Were incomplete outcome data adequately addressed?

Low risk of bias Any one of the following. • No missing outcome data. • Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias). • Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. • For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate. • For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size. • Missing data have been imputed using appropriate methods. High risk of bias Any one of the following. • Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups. • For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate. • For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size. • ‘As-treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation. • Potentially inappropriate application of simple imputation. Unclear Any one of the following. • Insufficient reporting of attrition/exclusions to permit judgement of low or high risk of bias (e.g. number randomised not stated, no reasons for missing data provided). • The study did not address this outcome. 5. Are reports of the study free of suggestion of selective outcome reporting?

Low risk of bias Any of the following. • The study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way. • The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specified (convincing text of this nature may be uncommon) High risk of bias Any one of the following. • Not all of the study’s pre-specified primary outcomes have been reported. • One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified. • One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect). Repositioning for treating pressure ulcers (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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• One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis. • The study report fails to include results for a key outcome that would be expected to have been reported for such a study. Unclear Insufficient information to permit judgement of low or high risk of bias. It is likely that the majority of studies will fall into this category.

6. Other sources of potential bias

Low risk of bias The study appears to be free of other sources of bias. High risk of bias There is at least one important risk of bias. For example, the study: • had a potential source of bias related to the specific study design used; or • has been claimed to have been fraudulent; or • had some other problem. Unclear There may be a risk of bias, but there is either: • insufficient information to assess whether an important risk of bias exists; or • insufficient rationale or evidence that an identified problem will introduce bias.

WHAT’S NEW Last assessed as up-to-date: 28 August 2014.

Date

Event

Description

28 August 2014

New citation required but conclusions have not changed Third update, no change to conclusions of review.

28 August 2014

New search has been performed

New search, no new studies identified.

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HISTORY Protocol first published: Issue 1, 2008 Review first published: Issue 2, 2009

Date

Event

Description

23 May 2012

New citation required but conclusions have not Second update, no change to conclusions of review. changed

23 May 2012

New search has been performed

New search, no new studies identified

8 January 2011

Amended

Contact details updated.

7 September 2010

New search has been performed

New search, no new studies identified, no change to conclusions of review

13 May 2008

Amended

Converted to new review format.

CONTRIBUTIONS OF AUTHORS Zena Moore: conceived, designed and coordinated the review. Completed first draft of the review and wrote to study authors, experts and companies and is the guarantor of the review. Seamus Cowman: conceived the review, performed part of writing and editing of the review and made an intellectual contribution to the review. Contributions of editorial base: Nicky Cullum: edited the review, advised on methodology, interpretation and review content. Approved the final review and the updates prior to submission. Sally Bell-Syer: coordinated the editorial process. Advised on methodology, interpretation and content. Edited the review and the review updates. Ruth Foxlee: designed the search strategy, ran the searches and edited the search methods section.

DECLARATIONS OF INTEREST Zena Moore, is a member of the medical advisory board of Systagenix Wound Management. Zena Moore, has received an honorarium for speaking at professional meetings for KCI, ConvaTec, Systagenix Wound Management, Fanin Health Care and Smith & Nephew, none of whom have an interest in the findings of this review.

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SOURCES OF SUPPORT Internal sources • The Faculty Board, Faculty of Nursing & Midwifery, RCSI, Ireland. • The Royal College of Surgeons in Ireland, Ireland.

External sources • Health Research Board of Ireland, Ireland. • The National Institute for Health Research (NIHR) is the sole funder of the Cochrane Wounds Group, UK.

INDEX TERMS Medical Subject Headings (MeSH) ∗ Moving

and Lifting Patients; ∗ Patient Positioning; ∗ Wound Healing; Pressure Ulcer [∗ therapy]

MeSH check words Humans

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Repositioning for treating pressure ulcers.

Pressure, from lying or sitting on a particular part of the body results in reduced oxygen and nutrient supply, impaired drainage of waste products an...
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