Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

Abstract

BackgroundDonor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds.MethodsA 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale). Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009.DiscussionThis study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s) that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such patients. Thus, we aim to contribute a well-designed trial, relevant to all clinicians involved in the care for donor site wounds, which will help enhance uniformity and quality of care for these patients.Trial registrationhttp://www.trialregister.nl, NTR1849. Date registered: June 9, 2009

Randomized clinical trial of donor-site wound dressings after split-skin grafting

“…The institutional review board of each contributing centre approved the study protocol, which has been published in detail elsewhere. Contrary to this protocol, the group ‘paraffin gauzes’ was renamed ‘gauzes’, because Adaptic ® (Systagenix, Gatwick, UK) was used in all but three patients (in whom Jelonet ® (Smith and Nephew Healthcare, Hull, UK) was applied).…”

Comparison of Three Different Methods of Dressing for Skin Graft Donor Site

“…Dressing adhesion to skin graft donor site, VAS score, and duration of dressing are presented in Table 2. The mean duration of hospitalization in group A was 17.96±1.4 days (range: 15-21 days), group B, 16.43±1.86 days (range: [13][14][15][16][17][18][19][20], and group C, 16.9±1.55 days (range: [14][15][16][17][18][19][20]. This figure was significantly higher in group A compared with group B and C (P<0.05), but there was no significant difference between groups B and C (P=0.6).…”

“…A partialthickness wound is created in the skin graft donor site that is healed by re-epithelialization. It takes 10-14 days to complete epithelialization [14,15].…”

Donor Site Healing Dynamics

“…37 Studies have demonstrated that full-thickness wounds in Duroc swine have a tendency toward fibro proliferative scaring, with more fibrosis, pigmentation, and contraction than other swine species. Our model allows for multiple biologic samples per wound as well as multiple wounds per animal.…”