Results of a Prospective Randomized Controlled Trial of Early Ambulation for Patients With Lower Extremity Autografts David John Lorello, PT, DPT,*‡ Michael Peck, MD, ScD, FACS,† Marlene Albrecht, RN,† Karen J. Richey, RN, BSN,† Melissa A. Pressman, PhD†

It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community. The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days. (J Burn Care Res 2014;35:431–436)

It is common practice to keep immobile a burn patient who has undergone autografting to the lower extremity (LE). The time frame varies from institution to institution, with some burn centers keeping their patients immobile for 5 days and longer.1 Determining when a patient can ambulate after a skin graft to the LE was dependent upon the establishment of circulation to the newly grafted area.2 Typically, the majority of revascularization takes between 4 to 6 days.3 Before revascularization there is a fear of increased risk of graft failure because of increased edema in the dependent limb, or as a result of shearing forces to the graft itself. From the *Department of Physical Therapy, Midwestern University, Glendale, Arizona; and the †Department of Surgery, Burn and Trauma, ‡The Arizona Burn Center at Maricopa Medical Center, Phoenix. Address correspondence to David J. Lorello, PT, DPT, Midwestern University, 19555 N. 59th Avenue, Glendale, Arizona 85308., Reprints address: Michael Peck, MD, ScD, FACS, The Arizona Burn Center, 2601 E Roosevelt, Phoenix, AZ 85008. Copyright © 2014 by the American Burn Association 1559-047X/2014 DOI: 10.1097/BCR.0000000000000014

There is, however, an inherent risk from immobility itself. As far back as 1944 many have commented on the risks associated with bed rest.4 In healthy subjects, short periods of bed rest have been associated with losses in muscle strength, decreases in orthostatic tolerance, tachycardia, and decreased stroke volume and cardiac output.5–7 Research has also shown muscle atrophy, insulin resistance, increased ectopic fat storage, and decreased high-density lipoprotein cholesterol can occur with immobility.8,9 Combined with the sequelae associated with burn injury, patients with even small TBSA burns have a chance to develop some measure of disability. Past research has shown the ability to mobilize patients before postoperative day (POD) 5.10–16 However, most of the previous studies used the Unna boot for compression on LE grafts.11–15,17 The Unna boot is a zinc-oxide–impregnated gauze that, when wrapped around an affected limb, provides compression through its semirigid construction. It also provides the grafted area protection from shearing. The Unna boot has been used extensively throughout the wound care community for the healing of venous 431



Journal of Burn Care & Research September/October 2014

432   Lorello et al

stasis ulcers.18,19 There is no significant difference in the healing rates of venous stasis ulcers between limbs wrapped with the Unna’s boot compared with limbs donned with compression stockings or wrapped in elastic bandages.18,19 Researchers also found that the Unna boot was more difficult to apply correctly and took a longer time to apply.18,19 Patients complained of more pain during application and removal, and the boot does not accommodate a high volume of exudate or to increases in limb size resulting from edema.18,19 In 2012 Nedelec et al20 published practice guidelines for burn survivors with LE autografts. They concluded that early ambulation could be safely initiated after LE skin grafting with the use of external compression.20 However, their findings could not include randomized controlled trials in the burn population, as none exist. To answer the question of whether or not patients with LE autografts can safely ambulate on POD 1 without increased risk of graft failure, our burn center initiated a prospective randomized controlled trial. Using physician evaluation of photographs taken of the subjects’ autografts on POD 5, we hypothesize that those subjects who ambulate on POD 1 will have no greater loss of autograft than those subjects who remain on bed rest until POD 5.

METHODS Our center’s Institutional Review Board approved this study. Patients aged 18 years and older with LE who were ambulatory were identified by the physical therapy team. Those patients who were determined as requiring autografts to heal and were ambulating a minimum of twice per day with the help of physical therapy before autograft placement were considered eligible for inclusion. Exclusion criteria are listed in Table 1. Subjects who met inclusion criteria consented to participate in the study before surgery. Data collected in the study are listed in Table 2. The clinical management of patients was consistent with previously published standard operating Table 1. Exclusion criteria • Patients under the age of 18 years • Patients with diabetes mellitus (including those patients presenting with a history of diabetes and those with an increased level of HgB A1C during their current hospitalization) • Patients with peripheral vascular disease • Patients with lower extremity pitting edema ≥ 2+ • Patients who develop cellulitis before surgery • Patients who are nonambulatory before surgery

Table 2. Data collected • Demographics: name, age, sex, height, weight, mechanism of injury, location(s) of burns, TBSA burned • Pain: using the visual analog scale. Subject will report graft and donor site pain • Surgical data: TBSA grafted, skin graft mesh ratios, percentage of graft take • Presurgery activity: minutes per treatment session with physical therapy • Postsurgical activity: minutes per treatment session with physical therapy • Postoperative day ambulation was started • Postoperative day of patient discharge • Total length of stay • Complications  Deep vein thrombosis  Pulmonary embolism  Urinary tract infection  Graft loss requiring surgery  Graft infection •  Length of stay

procedures.21 Patients with deep partial-thickness (deep second-degree) or full-thickness (third-degree) burns were taken to the operating room within a week of injury for the initial excision of burns. On the basis of the depth and clinical assessment of the attending surgeon, burn wounds were covered after the initial excision with autograft, xenograft, or allograft. Patients with wounds covered in allografts or xenografts resumed all activity with physical therapy on POD 1. Patients with wounds covered with allograft or xenograft were returned to the operating room approximately 5 to 7 days after the first excision, at which time repeat allografting, repeat xenograft, or autografting was done. This cycle was continued until the wounds were autografted and successfully closed. Tangential excision was performed on the burn wounds of all subjects in this study, using either the Watson (Medicon, Tuttlingen, German) or Goulian (Oluşum® Surgical Instruments, Samsum, Turkey) hand-held dermatomes. Hemostasis was achieved with topical application of an electrolyte solution containing epinephrine and thrombin, and with the electrocautery. Split-thickness autografts were secured to the wound surface using a combination of fibrin sealant (ARTISS, Baxter Healthcare Corp., Deerfield, IL), staples, and interrupted 4-0 plain gut suture (Ethicon, LLC, Guaynabo, Puerto Rico). Soft silicone wound contact layer (Mepitel®, Molnlycke Health Care, Norcross, GA) was placed on the grafts, followed by gauze dressings saturated with antibiotic solution (either Sulfamylon 5% (UDL Laboratories, Rockford, IL) or Vashe Wound Therapy (PuriCore,

Journal of Burn Care & Research Volume 35, Number 5

Malvern, PA). Physical therapy was consulted for intraoperative placement of immobilizing splints. Our standard protocol for autografts that cross joints is to splint the joint. Burns that cross the knee are splinted in knee extension with the use of an off-the-shelf knee immobilizer. Those burns that cross the ankle are splinted in neutral dorsiflexion using a polyester and polyurethane resin casting tape (Delta-Cast® Conformable, Johnson and Johnson, NJ). The rigid nature of the casting tape does not allow weight bearing during ambulation, so those subjects who had burns that crossed the ankle joint were issued an assistive device (AD) and were taught how to ambulate maintaining non–weight-bearing (NWB) precautions on the LE with the grafted ankle. This would allow the subject to be mobile with the grafted ankle in a dependent position. At the conclusion of surgery, subjects were randomized into either the standard treatment group (STG) or the early ambulation group (EAG). Subjects who were randomly assigned to the STG followed a protocol of bed rest until POD 5. Subjects assigned to EAG began ambulating with physical therapy on POD 1.

Standard Treatment Group Fourteen subjects were randomized to the STG. Those subjects in the STG were seen on PODs 1 to 4 for positioning of the involved LE, correct fit of splint, and they were asked to rate any pain they were having in their graft and donor site per the visual analog scale (VAS). The VAS consists of a 10-cm line with terminal anchors. The anchors represent the subject’s pain with the left anchor (zero) representing “no pain,” and the right anchor (10) representing “the worst pain imaginable.” The subject pointed to an area on the line where he or she felt the pain was. The therapist used the corresponding number as the numerical value for the subject’s pain.

Early Ambulation Group Seventeen subjects were randomized to the EAG. Beginning on POD 1, they were seen by the physical therapy team for ambulation. Before ambulating, the treating physical therapist wrapped the grafted LE with compression bandages in a figure-of-eight pattern. Splints were also checked for correct fit. Subjects were asked to state any pain they were having in their graft and donor sites per the VAS. Those EAG subjects who were taught to use an AD before surgery were given the AD to ambulate. Each EAG subject ambulated with the help of physical therapy until the subject determined he or she could not ambulate any further.

Lorello et al   433

EAG subjects were also asked to rate their graft and donor site pain per the VAS while ambulating. All pain scores and minutes ambulated were recorded. On POD 5 any splints were removed and all subjects were allowed to ambulate with physical therapy. The treating therapist tracked the total minutes the subject was able to ambulate minus any breaks the subject required. All subjects were asked to rate their graft and donor site pain before ambulation and during ambulation. Subjects were discharged when it was determined that they were independent with ambulation and that they could safely perform any required dressing changes at home. Independent ambulation was defined as the subject ambulating a minimum of 150 feet without an AD, without loss of balance in a timely manner.

Photographs Pictures of graft sites were taken for all subjects on POD 3, POD 5, and first to third postdischarge follow-up appointments. A burn surgeon who was blinded to group was given all photographs and determined, if any, percentage of graft loss that occurred.

RESULTS A total of 41 patients were enrolled, however, only 31 of those patients were included in the data analysis. The 10 subjects who were not included had Table 3. Demographics and burn history Variables Age, mean (SD) BMI, mean (SD) Sex, %  M  F Flame burn, n (%) Scald burn, n (%) Contact burn, n (%) Other burn, n (%) TBSA, mean (SD) Mean % grafted Graft type, %  Sheet  Meshed Cross knee joint, %  Yes  No Cross ankle joint, %  Yes  No Surgeries, n (SD)

EAG

STG

P

35.4 (16.4) 28.4 (5.9)

43.6 (14.8) 27.7 (10.1)

.16 .81

71 29 7 (41.2) 7 (41.2) 1 (5.9) 1 (5.9) 3.59 (2.06) 1.5 (1.9)

93 7 4 (28.6) 4 (28.6) 5 (35.7) 1 (7.1) 4.07 (4.18) 2.6 (3.1)

.34

23.5 76.5

14.3 85.7

.75

23.5 76.5

28.6 71.4

.83

58.8 41.2 2.1 (0.6)

42.9 57.1 2.4 (1.0)

.60

EAG, early ambulation group; STG, standard treatment group.

.72 .72 .10 .56 .68 .13

.29



Journal of Burn Care & Research September/October 2014

434   Lorello et al

Table 4. Areas autografted Left Lower Extremity Subject EAG 2 3 7 8 11 13 19 20 21 23 27 28 29 30 33 34 40 STG 1 10 12 14 15 16 17 24 26 32 36 38 39 41

Toes

Foot

Ankle

X X

X X

Lower Leg

Right Lower Extremity Knee

Thigh

Toes

Foot

Ankle

X X

Lower Leg

Knee

Thigh

X X X

X X X

X X X X X

X

X X

X X

X X

X X X

X

X

X

X X X X X

X X

X

X

X X

X X

X

X X

X X

X

X

X X X X X

X X X X

X X X

X

X

EAG, early ambulation group; STG, standard treatment group.

either not returned after discharge, or were randomized to the STG and had ambulated before POD 5. Demographic and burn history data, as well as areas autografted are summarized in Tables 3 and 4, and the statistical analysis found no differences between groups (P>.05). As was hypothesized, the analysis found that on POD 5 (Table 5) there was no difference in the number of patients with graft loss in the EAG (2 subjects) and STG (3 subjects). However, there was a significant difference in the mean percentage of graft loss, with the STG having a higher percentage of graft loss than the EAG (EAG 1.0% [SD 0.00], STG 7.7% [SD 2.52], P=.0376; Table 5). There was also a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03],

STG 14.1 [SD 9.00], P=. 0235; Table 5). Subjects in the STG rated their donor site and graft site pain higher than the those in EAG, with significantly more pain of the graft site at rest (STG 3.5/10 [SD 3.14], EAG 1.3/10 [SD 1.98], P =.0243; Table 5). There was no difference in length of stay for either group. Once subjects were discharged they received care once per week in our outpatient burn clinic. The data analysis found no difference between groups for the number of subjects with graft loss or the percentage of graft loss. A summary of the data can be found in Table 6.

DISCUSSION There have been many studies that have demonstrated the safety of ambulating patients with LE

Journal of Burn Care & Research Volume 35, Number 5

Lorello et al   435

Table 5. POD 5 data

Variables Minutes of ambulation, mean (SD) Graft pain at rest, mean (SD) Donor pain at rest, mean (SD) Graft pain ambulating, mean (SD) Donor pain ambulating, mean (SD) Participants with graft loss, n (%) Percentage of graft loss, mean (SD) Length of stay, mean (SD)  Minimum days  Maximum days

Table 6. Postdischarge visit data

*P

Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risk...
253KB Sizes 0 Downloads 4 Views