Quality Assurance & Process Innovation, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Trials. 2011 Oct 17;12:229. doi: 10.1186/1745-6215-12-229.
Donor 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.
A 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.
This 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.
http://www.trialregister.nl, NTR1849. Date registered: June 9, 2009.
游离皮片移植术后的供皮区创面是较为“标准”的创面。目前，有许多供皮区创面的敷料和外用药物可供选择。这导致了这些创面局部处理方法的巨大差异，而对于局部创面护理的最佳“标准”敷料尚不清楚。本方案描述了一项研究，旨在比较各种治疗方案对供皮区创面的效果。
这是一项在荷兰开展的 14 中心、6 臂随机临床试验。根据前期的效力分析和预计 15%的脱落率，我们需要每组 50 例患者（共 300 例），才能检测出愈合时间平均缩短 25%。采用计算机随机化以确保分组隐匿。纳入因任何原因需要游离皮片移植手术、且供皮区创面至少 10cm2 的成年患者，并为其使用以下敷料之一：水胶体、藻酸盐、薄膜、水纤维、硅酮敷料或凡士林纱布。本试验中不允许使用其他干预组的产品进行联合治疗。根据敷料制造商提供的方案，最佳应用和更换这些敷料。主要结局是完全愈合所需的天数和疼痛（使用视觉模拟评分）。次要结局包括不良事件、瘢痕、患者满意度和成本。不了解治疗分组的结局评估者将评估是否出现了结局。根据意向治疗原则进行分析结果。首例患者于 2009 年 10 月 1 日随机分组。
本研究将为供皮区创面不同治疗选择的效果提供全面的数据。在处理此类患者的临床医生中，将推广在有效性、满意度和成本方面占优势的敷料。因此，我们旨在提供一项精心设计的临床试验，该试验与所有参与供皮区创面护理的临床医生相关，这将有助于提高此类患者护理的一致性和质量。
