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Product Focus feature title to go here
Clinical focus
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Ulcer pain in patients with venous leg ulcers related to antibiotic treatment and compression therapy Abstract
Key words: Wound management Healing time
Health-related quality of life
Nina Åkesson
Registered Nurse, Blekinge Centre of Competence, Karlskrona, Sweden
Rut Frank Öien email: [email protected] General Practitioner, Blekinge Centre of Competence, Karlskrona, Sweden
Henrik Forssell
© 2014 MA Healthcare Ltd
Associate Professor, Blekinge Centre of Competence, Karlskrona, Sweden
Cecilia Fagerström
Department of Health, Blekinge Institute of Technology, Karlskrona, Sweden and Blekinge Center of Competence, Karlskrona, Sweden Accepted for publication 1 August 2014
difference between the two groups concerning compression therapy (85% vs. 88%), but 12% of patients in the ‘pain’ group did not get their prescribed compression compared with 6% of patients in the ‘no pain’ group. The groups did not differ significantly in terms of ulcer duration, ulcer size or healing time. This study shows a high incidence of ulcer pain, confirming that pain has a great impact on patients with venous leg ulcers. Results further suggest that the presence of ulcer pain increases the prescription of antibiotics but does not affect the use of compression therapy. Several advantages were found from using a national quality registry. The registry is a valuable clinical tool showing the importance of accurate diagnosis and effective treatment. Wound healing
Hard-to-heal ulcers
L
eg ulcers are a common health problem, causing great costs to society (Tennvall et al, 2004) and great suffering for the affected patients (Maddox, 2012). Ulcer pain in patients with venous leg ulcers is an underestimated problem in health care (Hofman et al, 1997; Persoon et al, 2004; Maddox, 2012), making it an important area for improvement in wound management. Several studies have examined patients’ perceptions of ulcer pain and its impact on quality of life, but research into the relationship between ulcer pain and wound healing is still lacking (Hofman et al, 1997). Studies on the relationships between pain and antibiotic treatment and between pain and compression therapy are also sparse.
Venous leg ulcers The complex issue of clinically assessing an ulcer infection is well known in wound management (Cutting and White, 2005; European Wound Management Association, 2006). Venous leg ulcers are often characterised by swollen ulcer edges, redness around the ulcer area, oedema, exudate, and pain—the same signs that indicate a clinical infection. When
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The aim of this study was to compare venous leg ulcer patients with and without ulcer pain to see whether ulcer pain affected the use of antibiotic treatment and compression therapy throughout healing. A total of 431 patients with venous leg ulcers were included during the study period. Every patient was registered in a national quality registry for patients with hard-to-heal leg, foot, and pressure ulcers. A high incidence of ulcer pain (57%) was found when the patients entered the study. Patients with ulcer pain had been treated more extensively with antibiotics both before and during the study period. Throughout healing there was a significant reduction of antibiotic use among patients in the ‘no pain’ group, from 44% to 23% (P=0.008). There was no significant
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Clinical focus: Leg ulcer pain study
pain or another of these signs becomes more prominent, and the healing process is delayed, an infection may be suspected. If the patient is treated by several caregivers and there is a lack of continuity of medical care, the patient is often prescribed antibiotics (Petursson, 2005). Lack of continuity of care could be the reason why GPs prescribe antibiotics in a ‘non pharmacological’ manner (Petursson, 2005), which is reflected by the fact that so many leg ulcer patients (68–78%) are treated with antibiotics (André et al, 2006). Previous studies have shown poor compliance to compression therapy, with pain being the main reason not to comply with the prescribed compression (Van Hecke et al, 2008; Moffatt et al, 2009). Pain is also a strong indicator of an arterial ulcer, and so the arterial circulation must be thoroughly assessed before initiating compression therapy (Hofman et al, 1997; Anderson, 2008). There is, as yet, no evidence regarding whether patients with painful venous leg ulcers are more often treated with antibiotic treatment and receive less compression therapy, and so such a connection cannot be ruled out. Increased knowledge of the impact of ulcer pain in clinical practice and the consequences for treatment strategies seems to be of the utmost importance for these patients.
Aims of study The aim of this study was to compare venous leg ulcer patients with and without ulcer pain to ascertain whether ulcer pain affected the use of antibiotic treatment and compression therapy throughout healing. The Swedish Registry of Ulcer Treatment (RUT) (www.rut-europe.eu) is able to present long-term data for more than 2500 patients (as of August 2014) on ulcer assessment, treatment strategies, and healing time. Hence, it is eminently suitable for the purposes of this study.
Method Study population Data were analysed for every patient with a venous leg ulcer (n=431) registered in RUT and healed during the study period (1 May 2009–2 February 2013).Venous ulcers constituted 35% of diagnoses among the 1216 fully healed patients in the RUT. The data covered 40 different Swedish units: 30 primary care units (75%), nine dermatology departments, and one community unit.
The Swedish Registry of Ulcer Treatment Earlier studies have noted that patients with hard-to-heal ulcers are often treated without a proper diagnosis, leading to suboptimal treatment (Hofman et al, 1997; Hjelm et al, 2000; Öien and Tennvall, 2006). This was the motivation behind the development of RUT, a quality registry introduced nationally in May 2009 as a tool for clinical assessment of hard-to-heal ulcers, treatment strategies and continuity of care (Öien, 2009). Patients with hard-to-heal leg, foot or pressure ulcers are registered by a nurse or physician on two occasions. The
first registration includes variables for assessment of the ulcer diagnosis, arterial circulation and treatment strategies. The second registration includes data on ulcer healing or negative clinical events such as amputation or death. The variables in RUT cover the patient’s history, ulcer history, medical status and ulcer treatment. There are 52 mandatory variables in RUT. For this study the following variables were chosen from the first registration: ulcer pain, degree of pain, sleep, ulcer duration, ulcer size, treatment with antibiotics due to ulcer infection, and prescribed compression treatment. From the second registration the following variables were chosen to reflect the healing process: healing time, number of dressing changes, compression therapy, and antibiotic treatment during the study period.
Pain Ulcer pain was documented using a visual analogue scale running from 0 (no pain) to 10 (the worst possible pain). Patients experiencing pain were asked whether the pain disturbed their sleep (‘yes’ or ‘no’).
Arterial circulation The patient’s arterial circulation was assessed by palpating the arteria dorsalis pedis and arteria tibialis posterior and measuring the ankle–brachial pressure index with a handheld Doppler. An ankle–brachial index greater than 0.9 was considered to indicate a venous ulcer. The Doppler was also used to measure deep or superficial venous insufficiency (vena saphena magna, vena saphena parva and vena poplitea). The diagnosis was determined from the variables reported in RUT in combination with the clinical examination.
Ulcer duration Ulcer duration was noted in days from the onset of the ulcer to the date of when the patient was included in the study (i.e. at the first registration). Healing time was defined as the number of days taken for the ulcer to heal.
Ulcer size Ulcer size was measured in cm2, either with a digital planimeter (Visitrak) or by multiplying the length and width of the ulcer. If the patient had more than one ulcer, the total ulcer size was documented.
Ulcer infection Ulcer infection was documented when the ulcer showed more pronounced pain, exudate, redness around the ulcer, or oedema, and healing was delayed as a result. In such cases the responsible physician ordered more frequent dressing changes and antimicrobial treatment for the next 1–2 weeks, during which time the patient was followed closely by their assigned ‘ulcer nurse’. If this strategy did not clear the infection, antibiotics were prescribed according to the result of the swab.
Antibiotic treatment Antibiotic treatment due to ulcer infection was registered
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Clinical focus: Leg ulcer pain study
for the period between the onset of the ulcer and the first registration in RUT, and again for the period between the first registration and the second registration (covering the time of the healing process).
Table 1. Patient demographic: ulcer pain at the first registration (%)
N=431
Analysis
Ulcer pain 245 (57)
No ulcer pain 186 (43)
Data were analysed for every patient with a venous leg ulcer (n=431) registered in RUT and healed during the study period (1 May 2009–2 February 2013). The inclusion criteria therefore covered all the mandatory variables for registration in RUT, one of which is pain. It was found that 57% of the patients with a venous ulcer had experienced pain when entering the study, so the patients were divided into two groups: the ‘pain’ group and the ‘no pain’ group. Using the variables in the registry, the groups were analysed from two perspectives: antibiotic treatment before entering the study and during the study period, and compression therapy during the study period.
Gender
Data analysis
Yes (%)
211 (49)
130 (53)
81 (44)
Statistical analysis was performed using Stata V13.1 (StataCorp LP, College Station, Texas, USA). Categorical variables were compared between groups using Pearson’s chi-squared test. Differences in groups were analysed using the two-sample Wilcoxon rank-sum test (Mann–Whitney U-test). A P-value of less than 0.05 was considered to indicate statistical significance.
No (%)
220 (51)
115 (47)
105 (56)
P-value
0.405*
Women (%)
276 (64)
161 (66)
115 (62)
Men (%)
155 (36)
84 (34)
71 (38)
Median age, years (IQR)
80 (69–88)
80 (68–88)
80 (70–87)
0.836†
Median ulcer duration, weeks (IQR)
12 (6–24)
12 (6–20)
12 (6–24)
0.486†
Median ulcer size, cm2 (IQR)
2.9 (1–8.9)
3.6 (1–11.6)
2.5 (0.7–6)
0.010†
Treatment with antibiotics before registration
0.050*
Prescribed compression
0.185*
Yes (%)
412 (96)
237 (97)
175 (94)
No (%)
19 (4)
8 (3)
11 (6)
Chi-squared test
*
†Two-sample Wilcoxon range test (Mann–Whitney)
The study results are mainly based on a master’s thesis carried out at the Blekinge Institute of Technology. All data were anonymised, and the material was reviewed in accordance with current practice concerning master’s theses.
Results
IQR = interquartile range
Figure 1. Pain measured by visual analogue scale in patients with ulcer pain
The study population comprised a total of 431 patients (64% women, 36% men) with a median age of 80 years (Table 1). There were 245 patients in the ‘pain’ group and 186 in the ‘no pain’ group.
Ulcer pain Ulcer pain was reported by 57% (245/431) of the patients (Table 1). The median visual analogue scale (VAS) value was 5, and one third of the patients evaluated their pain at 7 or more. Figure 1 shows the VAS distribution for the 218 patients who had evaluated their pain using the VAS scale. Not all patients with pain were able to report a VAS score, as some patients (n=27) reported pain but could not specify a value due to difficulties in understanding the VAS scale. Of the 245 patients with documented pain, 53% reported sleeping disturbances due to ulcer pain (data not shown).
Ulcer duration and ulcer size Median ulcer duration before registration in RUT was 12 weeks for both groups, with a maximum of 27 years for
40
30
20
10
0
1
2
3
4 5 6 7 8 Visual analogue scale
9
10
patients in the ‘pain’ group and 12 years for patients in the ‘no pain’ group (Table 1). Median ulcer size at registration in RUT was 3.6 cm² (maximum 400 cm2) in the ‘pain’ group and 2.5 cm2 (maximum 224 cm2) in the ‘no pain’ group.
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Ethical approval
Frequency
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Clinical focus: Leg ulcer pain study
Table 2. Patient demographics at ulcer healing (second registration) (%)
N= 431
Ulcer pain 245 (57)
No ulcer pain 186 (43)
P-value
Median healing time, days (IQR)
91 (51–189)
90 (56–174)
92 (47–192)
0.991*
Median frequency of dressing changes (IQR)
15 (7–30)
14 (7–28)
16 (6–32)
0.263*
Treatment with antibiotics
0.008†
Yes (%)
126 (29)
84 (34)
42 (23)
No (%)
305 (71)
161 (66)
144 (77)
Compression therapy
0.486†
Yes (%)
372 (86)
209 (85)
163 (88)
No (%)
59 (14)
36 (15)
23 (12)
*
Two-sample Wilcoxon rank-sum test (Mann-Whitney)
† Chi-squared test IQR = interquartile range
Healing time and dressing changes Table 2 shows the results at ulcer healing (the second registration in RUT). Median healing time was 90 days in the ‘pain’ group and 92 days in the ‘no pain’ group; that is, 13 weeks in both groups (P=0.991). When the ulcer duration (i.e. the time before entering the study) was added to the healing time in the study, the total ulcer healing time amounted to 24 weeks in both groups. Taking into account the difference in ulcer size between the ‘pain’ group and the ‘no pain’ group, after adjustment for ulcer size no significant difference in healing time was found between the groups. The frequency of dressing changes did not differ between the two groups, with a median of 1.1 and 1.2 dressing changes per week (P=0.263).
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Antibiotic treatment Patients with ulcer pain were more likely to have been treated with antibiotics before the study period (53%) in comparison to those with no pain (44%); the same pattern was evident for treatment during the study period (34% versus 23%). Furthermore, for patients in the ‘no pain’ group, antibiotic treatment was reduced from 44% to 23% during the study period, which constitutes a significant difference (P=0.008). Finally, the patients treated with antibiotics before the study period were more likely to receive antibiotic treatment during the study period (42%) compared to patients with no antibiotic treatment before registration in RUT (17%) (P=0.001).
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Compression therapy There was no significant difference between the two groups concerning compression therapy, which was administered to 85% of patients in the ‘pain’ group and 88% of patients in the ‘no pain’ group (Table 2). However, this therapy was prescribed to 97% and 94% of patients, respectively, during the healing process and so 12% of patients in the ‘pain’ group did not get their prescribed compression compared with 6% of patients in the ‘no pain’ group.
Discussion A high percentage of ulcer pain (57%) was found in patients with venous ulcers, which is in accordance with previous findings (Lindholm et al, 1992). Despite the high percentage, and the fact that pain has a negative impact on the quality of life of patients with hard-to-heal ulcers, earlier researchers have found that ulcer pain is often neglected by staff (Van Hecke et al, 2008; Törnvall and Wilhelmsson, 2010). It has been demonstrated that health professionals must ask every patient about ulcer pain and not rely on the patient to tell them, since many patients with hard-to-heal ulcers often accept pain as a normal and expected dimension of having an ulcer (Krasner, 1998; Husband, 2001). The main finding in this study was that patients with venous leg ulcers and ulcer pain differed significantly from patients with venous ulcers and no ulcer pain, in that patients with ulcer pain were more likely to be treated with antibiotics during the healing process, both before and during the study period. For patients in the ‘no pain’ group, antibiotic treatment was significantly reduced during the study period—a finding that has not been previously discussed in the literature to the best of the authors’ knowledge. Ulcer pain could indicate arterial insufficiency, but this was ruled out by the fact that every patient was assessed by a physician and diagnosed with a venous ulcer. Ulcer pain could also be related to an ulcer infection, with painful ulcers being infected to a greater extent than painfree ulcers. However, this latter possibility is contradicted by the results of Hofman et al (1997), who showed that, in patients with a painful venous leg ulcer, there were no signs of infection. A reduction was noted in antibiotic treatment for patients in the total group, from nearly 50% before the patients entered the study to 29% between registration and healing. This is still a high percentage, considering that only 4% of leg ulcer patients actually need antibiotics (Nelzen et al, 1994; Öien and Åkesson, 2012). The high rate of oral antibiotic treatment for patients outside the registry may be explained by the fact that many of these patients do not have access to specialised leg ulcer teams with continuity of care.
Use of database It is likely that the use of the RUT was an important contributing factor to the reduction in antibiotic treatment,
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Clinical focus: Leg ulcer pain study
as it gives staff a practical tool for structured wound management and treatment strategies including continuity of care until ulcer healing (Öien, 2009).
Ulcer pain and healing time The median estimated value of ulcer pain on the VAS was 5, and one third of the patients rated their pain at 7 or higher. The majority of the study’s patients with ulcer pain (53%) declared that the ulcer pain caused sleeping disturbances; this finding was also noted by Hofman et al (1997), who reported that 63.8% of patients had disturbed sleep due to pain. It is interesting that, although data on ulcer pain prior to inclusion is missing, the median ulcer duration before registration in RUT was 12 weeks—patients could have experienced pain for the entirety of this time. However, the median healing time was 13 weeks in both the ‘pain’ and ‘no pain’ groups. This finding contrasts with some of the literature that reports that painful ulcers have longer healing times (Krasner, 1998).
Compression Another important result is that a high proportion of the patients not only were prescribed compression (96%) but also received such treatment (86%), which can be explained by the fact that every patient had an assessed diagnosis of venous ulcer. This is in contrast with previous studies which have shown that diagnosis is often lacking for patients with hard-to-heal ulcers (Hjelm et al, 2000; Öien and Tennvall, 2006), and that only 58–67% of patients with venous ulcers were treated with compression (Price et al, 2008;Van Hecke, 2008). The overwhelming majority of patients in this study had been prescribed compression by a GP. It is likely that this made it easier for nurses to motivate the patient to accept compression, as pointed out in earlier studies (Annells et al, 2008). Only a slight difference was found in compression treatment between the two groups: 85% for patients with pain and 88% for patients without pain. This difference might indicate that patients with painful venous ulcers did not receive optimal compression, which is known to be the single most important treatment for venous ulcers (O’Meara et al, 2012). Previous studies have shown poor compliance to compression therapy, with pain being the main reason not to comply with the prescribed compression (Van Hecke, 2008; Moffatt et al, 2009). For patients with painful venous insufficiency, compression therapy in itself can be pain relieving (Nemeth et al, 2004). Since the degree of compression was not considered in this study, it is possible that the patients with ulcer pain received a lower grade of compression than patients without ulcer pain. Earlier researchers have found that healing time was shorter for patients treated with a higher degree of compression (O’Meara et al, 2012). In the present study the median healing time was the same for the two groups; if patients with ulcer pain had received a lower degree of compression, this would not be the case.
Strengths and weaknesses of study The patient demographic in this study was consistent with most other studies (Lindholm et al, 1992; Tennvall et al, 2004),
suggesting that inclusion in the registry was not biased. There are several advantages to retrieving data from a national quality registry such as RUT, as it includes a large study population and variables that could clarify the complex issue of wound management. However, one weakness of the study is that the registry does not include data on how many occasions the patients were given antibiotic treatment, or on what kind of compression therapy was used. Another weakness could be that the population group consisted of patients with healed venous ulcers. The study did not consider patients with unhealed ulcers, patients who had undergone amputation, or patients who had died. Thus, the results are representative only for patients with healed venous ulcers. Further research into the relationship between ulcer pain and compression therapy might shed some light on important factors for patient compliance towards compression treatment.
Conclusion The results of this study show a high incidence of ulcer pain, confirming that pain has a significant impact on patients with venous leg ulcers. The results further suggest that the presence of ulcer pain increases the prescription of antibiotics but does not affect the use of compression therapy. There were also several advantages discovered from using a national quality registry such as the RUT. The registry is a valuable clinical tool, showing the importance of accurate diagnosis and, hence, effective treatment. The large study population in RUT makes further clinical trials and research possible, which could lead to additional knowledge of the complexity of wound management. CWC
Declaration of interest This study was partly funded by the Council of Sciences in Blekinge County. The authors have no conflicts of interest to declare. Anderson I (2008) Mixed aetiology: complexity and comorbidity in leg ulceration. Br J Nurs 17(15): S17–S23 André M, Eriksson M, Odenholt I (2006) Treatment of patients with skin and soft tissue infections: results from the STRAMA survey of diagnoses and prescriptions among general practitioners. Lakartidningen 103: 3165–7. (In Swedish.) Annells M, O’Neill J, Flowers C (2008) Compression bandaging for venous leg ulcers: the essentialness of a willing patient. J Clin Nurs 17(3): 350–9. doi: 10.1111/j.13652702.2007.01996.x Cutting KF, White RJ (2005) Criteria for identifying wound infection: revisited. Ostomy Wound Manage 51(1): 28–34 European Wound Management Association (2006) Position Document: Management of Wound Infection. http://tinyurl.com/lguau2t (accessed 31 July 2014) Hjelm K, Nyberg P, Apelquist J (2000) Chronic leg ulcers in Sweden: a survey of wound management. J Wound Care 11: 131–6 Hofman D, Ryan TJ, Arnold F et al (1997) Pain in venous leg ulcers. J Wound Care 6(5): 222–4 Husband LL (2001) Shaping the trajectory of patients with venous ulceration in primary care. Health Expect 4: 189–198 Krasner D (1998) Painful venous ulcers: themes and stories about living with the pain and suffering. J Wound Ostomy Continence Nurs 25: 158–68 Lindholm C, Bjellerup M, Christensen OB, Zederfeldt B (1992) A demographic survey of leg and foot ulcer patients in a defined population. Acta Derm Venereol 72: 227–30 Maddox D (2012) Effects of venous leg ulceration on patients’ quality of life. Nurs Stand 26(38): 42–9 Moffatt C, Kommala D, Dourdin N, Choe Y (2009) Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention or recur-
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Clinical Clinicalfocus: focus: Leg Legulcer ulcerpain painstudy study
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KEY POINTS
rence. Int Wound J 6(5): 386–93. oi: 10.1111/j.1742-481X.2009.00634.x Nelzen O, Bergqvist D, Lindhagen A (1994) Venous and non-venous leg ulcers: clinical history and appearance in a population study. Br J Surg 81: 182–7 Nemeth K, Harrison M, Graham I, Burke S (2004) Understanding venous leg ulcer pain: result of a longitudinal study. Ostomy Wound Manage 50(1): 34–6 Öien RF (2009) Registering ulcer treatment through a national quality register: RUT—a winning concept for both patients and the health care sector. EWMA J 9(2): 41–4 Öien R, Åkesson N (2012) Bacterial cultures, rapid test, and antibiotic treatment in infected hard-to-heal ulcers in primary care. Scand J Prim Health Care 30: 254–8. doi: 10.3109/02813432.2012.711192 Öien R,Tennvall G (2006) Accurate diagnosis and effective treatment of leg ulcers reduce prevalence, care time and costs. J Wound Care 15: 259–62 O’Meara S, Cullum N, Nelson EA, Dumville JC (2012) Compression for venous leg ulcers. Cochrane Database Syst Rev 2012(11): CD000265. doi: 10.1002/14651858. CD000265.pub3 Persoon A, Heinen M, van der Vleuten C, de Rooij MJ, van de Kerkhof PC, van Achterberg T (2004) Leg ulcers: a review of their impact on daily life. J Clin Nurs 13: 341–54 Petursson P (2005) GPs’ reasons for ‘non-pharmacological’ prescribing of antibiotics: a phenomenological study. Scand J Prim Health Care 23: 120–5 Price PE, Fagervik-Morton H, Mudge EJ et al (2008) Dressing-related pain in patients with chronic wounds: an international patient perspective. Int Wound J 5(2): 159–171. doi: 10.1111/j.1742-481X.2008.00471.x Tennvall GR, Andersson K, Bjellerup M, Hjelmgren J, Oien R (2004) Treatment of venous leg ulcers can be better and cheaper: annual costs calculation based on an inquiry study. Lakartidningen 101(17): 1506–10–13. (In Swedish.) Törnvall E,Wilhelmsson S (2010) Quality of nursing care from the perspective of patients with leg ulcers. J Wound Care 19(9): 388–95 Van Hecke A, Grypdonk M, Defloor T (2008) Intervention to enhance patient compliance with leg ulcer treatment: a review of the literature. J Clin Nurs 17: 29–39
The results of this study show a high incidence of ulcer pain (57%) confirming that pain has a significant impact on patients with venous leg ulcers
The results further suggest that the presence of ulcer pain increases the prescription of antibiotics but does not affect the use of compression therapy
A national quality registry, such as the Registry of Ulcer Treatment (RUT), is a valuable clinical tool, showing the importance of accurate diagnosis and, hence, effective treatment
The large study population in RUT makes further clinical trials and research possible, which could lead to additional knowledge of the complexity of wound management
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Product Focus feature title to go here
Clinical focus
S6
Ulcer pain in patients with venous leg ulcers related to antibiotic treatment and compression therapy Abstract
Key words: Wound management Healing time
Health-related quality of life
Nina Åkesson
Registered Nurse, Blekinge Centre of Competence, Karlskrona, Sweden
Rut Frank Öien email: [email protected] General Practitioner, Blekinge Centre of Competence, Karlskrona, Sweden
Henrik Forssell
© 2014 MA Healthcare Ltd
Associate Professor, Blekinge Centre of Competence, Karlskrona, Sweden
Cecilia Fagerström
Department of Health, Blekinge Institute of Technology, Karlskrona, Sweden and Blekinge Center of Competence, Karlskrona, Sweden Accepted for publication 1 August 2014
difference between the two groups concerning compression therapy (85% vs. 88%), but 12% of patients in the ‘pain’ group did not get their prescribed compression compared with 6% of patients in the ‘no pain’ group. The groups did not differ significantly in terms of ulcer duration, ulcer size or healing time. This study shows a high incidence of ulcer pain, confirming that pain has a great impact on patients with venous leg ulcers. Results further suggest that the presence of ulcer pain increases the prescription of antibiotics but does not affect the use of compression therapy. Several advantages were found from using a national quality registry. The registry is a valuable clinical tool showing the importance of accurate diagnosis and effective treatment. Wound healing
Hard-to-heal ulcers
L
eg ulcers are a common health problem, causing great costs to society (Tennvall et al, 2004) and great suffering for the affected patients (Maddox, 2012). Ulcer pain in patients with venous leg ulcers is an underestimated problem in health care (Hofman et al, 1997; Persoon et al, 2004; Maddox, 2012), making it an important area for improvement in wound management. Several studies have examined patients’ perceptions of ulcer pain and its impact on quality of life, but research into the relationship between ulcer pain and wound healing is still lacking (Hofman et al, 1997). Studies on the relationships between pain and antibiotic treatment and between pain and compression therapy are also sparse.
Venous leg ulcers The complex issue of clinically assessing an ulcer infection is well known in wound management (Cutting and White, 2005; European Wound Management Association, 2006). Venous leg ulcers are often characterised by swollen ulcer edges, redness around the ulcer area, oedema, exudate, and pain—the same signs that indicate a clinical infection. When
2014 MA MA Healthcare Healthcare Ltd Ltd ©© 2014
The aim of this study was to compare venous leg ulcer patients with and without ulcer pain to see whether ulcer pain affected the use of antibiotic treatment and compression therapy throughout healing. A total of 431 patients with venous leg ulcers were included during the study period. Every patient was registered in a national quality registry for patients with hard-to-heal leg, foot, and pressure ulcers. A high incidence of ulcer pain (57%) was found when the patients entered the study. Patients with ulcer pain had been treated more extensively with antibiotics both before and during the study period. Throughout healing there was a significant reduction of antibiotic use among patients in the ‘no pain’ group, from 44% to 23% (P=0.008). There was no significant
Community Wound Care March September 2014 2014 sh Journal of Community Nursing. Downloaded from magonlinelibrary.com by 147.188.128.074 on August 24, 2015. For personal use only. No other uses without permission. . All rights rese
Clinical focus: Leg ulcer pain study
pain or another of these signs becomes more prominent, and the healing process is delayed, an infection may be suspected. If the patient is treated by several caregivers and there is a lack of continuity of medical care, the patient is often prescribed antibiotics (Petursson, 2005). Lack of continuity of care could be the reason why GPs prescribe antibiotics in a ‘non pharmacological’ manner (Petursson, 2005), which is reflected by the fact that so many leg ulcer patients (68–78%) are treated with antibiotics (André et al, 2006). Previous studies have shown poor compliance to compression therapy, with pain being the main reason not to comply with the prescribed compression (Van Hecke et al, 2008; Moffatt et al, 2009). Pain is also a strong indicator of an arterial ulcer, and so the arterial circulation must be thoroughly assessed before initiating compression therapy (Hofman et al, 1997; Anderson, 2008). There is, as yet, no evidence regarding whether patients with painful venous leg ulcers are more often treated with antibiotic treatment and receive less compression therapy, and so such a connection cannot be ruled out. Increased knowledge of the impact of ulcer pain in clinical practice and the consequences for treatment strategies seems to be of the utmost importance for these patients.
Aims of study The aim of this study was to compare venous leg ulcer patients with and without ulcer pain to ascertain whether ulcer pain affected the use of antibiotic treatment and compression therapy throughout healing. The Swedish Registry of Ulcer Treatment (RUT) (www.rut-europe.eu) is able to present long-term data for more than 2500 patients (as of August 2014) on ulcer assessment, treatment strategies, and healing time. Hence, it is eminently suitable for the purposes of this study.
Method Study population Data were analysed for every patient with a venous leg ulcer (n=431) registered in RUT and healed during the study period (1 May 2009–2 February 2013).Venous ulcers constituted 35% of diagnoses among the 1216 fully healed patients in the RUT. The data covered 40 different Swedish units: 30 primary care units (75%), nine dermatology departments, and one community unit.
The Swedish Registry of Ulcer Treatment Earlier studies have noted that patients with hard-to-heal ulcers are often treated without a proper diagnosis, leading to suboptimal treatment (Hofman et al, 1997; Hjelm et al, 2000; Öien and Tennvall, 2006). This was the motivation behind the development of RUT, a quality registry introduced nationally in May 2009 as a tool for clinical assessment of hard-to-heal ulcers, treatment strategies and continuity of care (Öien, 2009). Patients with hard-to-heal leg, foot or pressure ulcers are registered by a nurse or physician on two occasions. The
first registration includes variables for assessment of the ulcer diagnosis, arterial circulation and treatment strategies. The second registration includes data on ulcer healing or negative clinical events such as amputation or death. The variables in RUT cover the patient’s history, ulcer history, medical status and ulcer treatment. There are 52 mandatory variables in RUT. For this study the following variables were chosen from the first registration: ulcer pain, degree of pain, sleep, ulcer duration, ulcer size, treatment with antibiotics due to ulcer infection, and prescribed compression treatment. From the second registration the following variables were chosen to reflect the healing process: healing time, number of dressing changes, compression therapy, and antibiotic treatment during the study period.
Pain Ulcer pain was documented using a visual analogue scale running from 0 (no pain) to 10 (the worst possible pain). Patients experiencing pain were asked whether the pain disturbed their sleep (‘yes’ or ‘no’).
Arterial circulation The patient’s arterial circulation was assessed by palpating the arteria dorsalis pedis and arteria tibialis posterior and measuring the ankle–brachial pressure index with a handheld Doppler. An ankle–brachial index greater than 0.9 was considered to indicate a venous ulcer. The Doppler was also used to measure deep or superficial venous insufficiency (vena saphena magna, vena saphena parva and vena poplitea). The diagnosis was determined from the variables reported in RUT in combination with the clinical examination.
Ulcer duration Ulcer duration was noted in days from the onset of the ulcer to the date of when the patient was included in the study (i.e. at the first registration). Healing time was defined as the number of days taken for the ulcer to heal.
Ulcer size Ulcer size was measured in cm2, either with a digital planimeter (Visitrak) or by multiplying the length and width of the ulcer. If the patient had more than one ulcer, the total ulcer size was documented.
Ulcer infection Ulcer infection was documented when the ulcer showed more pronounced pain, exudate, redness around the ulcer, or oedema, and healing was delayed as a result. In such cases the responsible physician ordered more frequent dressing changes and antimicrobial treatment for the next 1–2 weeks, during which time the patient was followed closely by their assigned ‘ulcer nurse’. If this strategy did not clear the infection, antibiotics were prescribed according to the result of the swab.
Antibiotic treatment Antibiotic treatment due to ulcer infection was registered
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Clinical focus: Leg ulcer pain study
for the period between the onset of the ulcer and the first registration in RUT, and again for the period between the first registration and the second registration (covering the time of the healing process).
Table 1. Patient demographic: ulcer pain at the first registration (%)
N=431
Analysis
Ulcer pain 245 (57)
No ulcer pain 186 (43)
Data were analysed for every patient with a venous leg ulcer (n=431) registered in RUT and healed during the study period (1 May 2009–2 February 2013). The inclusion criteria therefore covered all the mandatory variables for registration in RUT, one of which is pain. It was found that 57% of the patients with a venous ulcer had experienced pain when entering the study, so the patients were divided into two groups: the ‘pain’ group and the ‘no pain’ group. Using the variables in the registry, the groups were analysed from two perspectives: antibiotic treatment before entering the study and during the study period, and compression therapy during the study period.
Gender
Data analysis
Yes (%)
211 (49)
130 (53)
81 (44)
Statistical analysis was performed using Stata V13.1 (StataCorp LP, College Station, Texas, USA). Categorical variables were compared between groups using Pearson’s chi-squared test. Differences in groups were analysed using the two-sample Wilcoxon rank-sum test (Mann–Whitney U-test). A P-value of less than 0.05 was considered to indicate statistical significance.
No (%)
220 (51)
115 (47)
105 (56)
P-value
0.405*
Women (%)
276 (64)
161 (66)
115 (62)
Men (%)
155 (36)
84 (34)
71 (38)
Median age, years (IQR)
80 (69–88)
80 (68–88)
80 (70–87)
0.836†
Median ulcer duration, weeks (IQR)
12 (6–24)
12 (6–20)
12 (6–24)
0.486†
Median ulcer size, cm2 (IQR)
2.9 (1–8.9)
3.6 (1–11.6)
2.5 (0.7–6)
0.010†
Treatment with antibiotics before registration
0.050*
Prescribed compression
0.185*
Yes (%)
412 (96)
237 (97)
175 (94)
No (%)
19 (4)
8 (3)
11 (6)
Chi-squared test
*
†Two-sample Wilcoxon range test (Mann–Whitney)
The study results are mainly based on a master’s thesis carried out at the Blekinge Institute of Technology. All data were anonymised, and the material was reviewed in accordance with current practice concerning master’s theses.
Results
IQR = interquartile range
Figure 1. Pain measured by visual analogue scale in patients with ulcer pain
The study population comprised a total of 431 patients (64% women, 36% men) with a median age of 80 years (Table 1). There were 245 patients in the ‘pain’ group and 186 in the ‘no pain’ group.
Ulcer pain Ulcer pain was reported by 57% (245/431) of the patients (Table 1). The median visual analogue scale (VAS) value was 5, and one third of the patients evaluated their pain at 7 or more. Figure 1 shows the VAS distribution for the 218 patients who had evaluated their pain using the VAS scale. Not all patients with pain were able to report a VAS score, as some patients (n=27) reported pain but could not specify a value due to difficulties in understanding the VAS scale. Of the 245 patients with documented pain, 53% reported sleeping disturbances due to ulcer pain (data not shown).
Ulcer duration and ulcer size Median ulcer duration before registration in RUT was 12 weeks for both groups, with a maximum of 27 years for
40
30
20
10
0
1
2
3
4 5 6 7 8 Visual analogue scale
9
10
patients in the ‘pain’ group and 12 years for patients in the ‘no pain’ group (Table 1). Median ulcer size at registration in RUT was 3.6 cm² (maximum 400 cm2) in the ‘pain’ group and 2.5 cm2 (maximum 224 cm2) in the ‘no pain’ group.
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Ethical approval
Frequency
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Clinical focus: Leg ulcer pain study
Table 2. Patient demographics at ulcer healing (second registration) (%)
N= 431
Ulcer pain 245 (57)
No ulcer pain 186 (43)
P-value
Median healing time, days (IQR)
91 (51–189)
90 (56–174)
92 (47–192)
0.991*
Median frequency of dressing changes (IQR)
15 (7–30)
14 (7–28)
16 (6–32)
0.263*
Treatment with antibiotics
0.008†
Yes (%)
126 (29)
84 (34)
42 (23)
No (%)
305 (71)
161 (66)
144 (77)
Compression therapy
0.486†
Yes (%)
372 (86)
209 (85)
163 (88)
No (%)
59 (14)
36 (15)
23 (12)
*
Two-sample Wilcoxon rank-sum test (Mann-Whitney)
† Chi-squared test IQR = interquartile range
Healing time and dressing changes Table 2 shows the results at ulcer healing (the second registration in RUT). Median healing time was 90 days in the ‘pain’ group and 92 days in the ‘no pain’ group; that is, 13 weeks in both groups (P=0.991). When the ulcer duration (i.e. the time before entering the study) was added to the healing time in the study, the total ulcer healing time amounted to 24 weeks in both groups. Taking into account the difference in ulcer size between the ‘pain’ group and the ‘no pain’ group, after adjustment for ulcer size no significant difference in healing time was found between the groups. The frequency of dressing changes did not differ between the two groups, with a median of 1.1 and 1.2 dressing changes per week (P=0.263).
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Antibiotic treatment Patients with ulcer pain were more likely to have been treated with antibiotics before the study period (53%) in comparison to those with no pain (44%); the same pattern was evident for treatment during the study period (34% versus 23%). Furthermore, for patients in the ‘no pain’ group, antibiotic treatment was reduced from 44% to 23% during the study period, which constitutes a significant difference (P=0.008). Finally, the patients treated with antibiotics before the study period were more likely to receive antibiotic treatment during the study period (42%) compared to patients with no antibiotic treatment before registration in RUT (17%) (P=0.001).
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Compression therapy There was no significant difference between the two groups concerning compression therapy, which was administered to 85% of patients in the ‘pain’ group and 88% of patients in the ‘no pain’ group (Table 2). However, this therapy was prescribed to 97% and 94% of patients, respectively, during the healing process and so 12% of patients in the ‘pain’ group did not get their prescribed compression compared with 6% of patients in the ‘no pain’ group.
Discussion A high percentage of ulcer pain (57%) was found in patients with venous ulcers, which is in accordance with previous findings (Lindholm et al, 1992). Despite the high percentage, and the fact that pain has a negative impact on the quality of life of patients with hard-to-heal ulcers, earlier researchers have found that ulcer pain is often neglected by staff (Van Hecke et al, 2008; Törnvall and Wilhelmsson, 2010). It has been demonstrated that health professionals must ask every patient about ulcer pain and not rely on the patient to tell them, since many patients with hard-to-heal ulcers often accept pain as a normal and expected dimension of having an ulcer (Krasner, 1998; Husband, 2001). The main finding in this study was that patients with venous leg ulcers and ulcer pain differed significantly from patients with venous ulcers and no ulcer pain, in that patients with ulcer pain were more likely to be treated with antibiotics during the healing process, both before and during the study period. For patients in the ‘no pain’ group, antibiotic treatment was significantly reduced during the study period—a finding that has not been previously discussed in the literature to the best of the authors’ knowledge. Ulcer pain could indicate arterial insufficiency, but this was ruled out by the fact that every patient was assessed by a physician and diagnosed with a venous ulcer. Ulcer pain could also be related to an ulcer infection, with painful ulcers being infected to a greater extent than painfree ulcers. However, this latter possibility is contradicted by the results of Hofman et al (1997), who showed that, in patients with a painful venous leg ulcer, there were no signs of infection. A reduction was noted in antibiotic treatment for patients in the total group, from nearly 50% before the patients entered the study to 29% between registration and healing. This is still a high percentage, considering that only 4% of leg ulcer patients actually need antibiotics (Nelzen et al, 1994; Öien and Åkesson, 2012). The high rate of oral antibiotic treatment for patients outside the registry may be explained by the fact that many of these patients do not have access to specialised leg ulcer teams with continuity of care.
Use of database It is likely that the use of the RUT was an important contributing factor to the reduction in antibiotic treatment,
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Clinical focus: Leg ulcer pain study
as it gives staff a practical tool for structured wound management and treatment strategies including continuity of care until ulcer healing (Öien, 2009).
Ulcer pain and healing time The median estimated value of ulcer pain on the VAS was 5, and one third of the patients rated their pain at 7 or higher. The majority of the study’s patients with ulcer pain (53%) declared that the ulcer pain caused sleeping disturbances; this finding was also noted by Hofman et al (1997), who reported that 63.8% of patients had disturbed sleep due to pain. It is interesting that, although data on ulcer pain prior to inclusion is missing, the median ulcer duration before registration in RUT was 12 weeks—patients could have experienced pain for the entirety of this time. However, the median healing time was 13 weeks in both the ‘pain’ and ‘no pain’ groups. This finding contrasts with some of the literature that reports that painful ulcers have longer healing times (Krasner, 1998).
Compression Another important result is that a high proportion of the patients not only were prescribed compression (96%) but also received such treatment (86%), which can be explained by the fact that every patient had an assessed diagnosis of venous ulcer. This is in contrast with previous studies which have shown that diagnosis is often lacking for patients with hard-to-heal ulcers (Hjelm et al, 2000; Öien and Tennvall, 2006), and that only 58–67% of patients with venous ulcers were treated with compression (Price et al, 2008;Van Hecke, 2008). The overwhelming majority of patients in this study had been prescribed compression by a GP. It is likely that this made it easier for nurses to motivate the patient to accept compression, as pointed out in earlier studies (Annells et al, 2008). Only a slight difference was found in compression treatment between the two groups: 85% for patients with pain and 88% for patients without pain. This difference might indicate that patients with painful venous ulcers did not receive optimal compression, which is known to be the single most important treatment for venous ulcers (O’Meara et al, 2012). Previous studies have shown poor compliance to compression therapy, with pain being the main reason not to comply with the prescribed compression (Van Hecke, 2008; Moffatt et al, 2009). For patients with painful venous insufficiency, compression therapy in itself can be pain relieving (Nemeth et al, 2004). Since the degree of compression was not considered in this study, it is possible that the patients with ulcer pain received a lower grade of compression than patients without ulcer pain. Earlier researchers have found that healing time was shorter for patients treated with a higher degree of compression (O’Meara et al, 2012). In the present study the median healing time was the same for the two groups; if patients with ulcer pain had received a lower degree of compression, this would not be the case.
Strengths and weaknesses of study The patient demographic in this study was consistent with most other studies (Lindholm et al, 1992; Tennvall et al, 2004),
suggesting that inclusion in the registry was not biased. There are several advantages to retrieving data from a national quality registry such as RUT, as it includes a large study population and variables that could clarify the complex issue of wound management. However, one weakness of the study is that the registry does not include data on how many occasions the patients were given antibiotic treatment, or on what kind of compression therapy was used. Another weakness could be that the population group consisted of patients with healed venous ulcers. The study did not consider patients with unhealed ulcers, patients who had undergone amputation, or patients who had died. Thus, the results are representative only for patients with healed venous ulcers. Further research into the relationship between ulcer pain and compression therapy might shed some light on important factors for patient compliance towards compression treatment.
Conclusion The results of this study show a high incidence of ulcer pain, confirming that pain has a significant impact on patients with venous leg ulcers. The results further suggest that the presence of ulcer pain increases the prescription of antibiotics but does not affect the use of compression therapy. There were also several advantages discovered from using a national quality registry such as the RUT. The registry is a valuable clinical tool, showing the importance of accurate diagnosis and, hence, effective treatment. The large study population in RUT makes further clinical trials and research possible, which could lead to additional knowledge of the complexity of wound management. CWC
Declaration of interest This study was partly funded by the Council of Sciences in Blekinge County. The authors have no conflicts of interest to declare. Anderson I (2008) Mixed aetiology: complexity and comorbidity in leg ulceration. Br J Nurs 17(15): S17–S23 André M, Eriksson M, Odenholt I (2006) Treatment of patients with skin and soft tissue infections: results from the STRAMA survey of diagnoses and prescriptions among general practitioners. Lakartidningen 103: 3165–7. (In Swedish.) Annells M, O’Neill J, Flowers C (2008) Compression bandaging for venous leg ulcers: the essentialness of a willing patient. J Clin Nurs 17(3): 350–9. doi: 10.1111/j.13652702.2007.01996.x Cutting KF, White RJ (2005) Criteria for identifying wound infection: revisited. Ostomy Wound Manage 51(1): 28–34 European Wound Management Association (2006) Position Document: Management of Wound Infection. http://tinyurl.com/lguau2t (accessed 31 July 2014) Hjelm K, Nyberg P, Apelquist J (2000) Chronic leg ulcers in Sweden: a survey of wound management. J Wound Care 11: 131–6 Hofman D, Ryan TJ, Arnold F et al (1997) Pain in venous leg ulcers. J Wound Care 6(5): 222–4 Husband LL (2001) Shaping the trajectory of patients with venous ulceration in primary care. Health Expect 4: 189–198 Krasner D (1998) Painful venous ulcers: themes and stories about living with the pain and suffering. J Wound Ostomy Continence Nurs 25: 158–68 Lindholm C, Bjellerup M, Christensen OB, Zederfeldt B (1992) A demographic survey of leg and foot ulcer patients in a defined population. Acta Derm Venereol 72: 227–30 Maddox D (2012) Effects of venous leg ulceration on patients’ quality of life. Nurs Stand 26(38): 42–9 Moffatt C, Kommala D, Dourdin N, Choe Y (2009) Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention or recur-
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Clinical Clinicalfocus: focus: Leg Legulcer ulcerpain painstudy study
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KEY POINTS
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The results of this study show a high incidence of ulcer pain (57%) confirming that pain has a significant impact on patients with venous leg ulcers
The results further suggest that the presence of ulcer pain increases the prescription of antibiotics but does not affect the use of compression therapy
A national quality registry, such as the Registry of Ulcer Treatment (RUT), is a valuable clinical tool, showing the importance of accurate diagnosis and, hence, effective treatment
The large study population in RUT makes further clinical trials and research possible, which could lead to additional knowledge of the complexity of wound management
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