Donovan Michelle L, Muller Michael J, Simpson Claire, Rudd Michael, Paratz Jennifer
Occupational Therapy Department, Royal Brisbane and Women's Hospital, Level 2, Dr James Mayne Building, Herston, QLD, 4029, Australia.
Burns, Trauma & Critical Care Research Centre, School of Medicine, University of Queensland, Herston, QLD, 4029, Australia.
Trials. 2016 Apr 26;17(1):214. doi: 10.1186/s13063-016-1329-x.
Pressure garment therapy (PGT) is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24-40 mmHg) in these garments can support scar minimisation, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4-6 mmHg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been twofold. IPGs for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggests that IPGs also make a difference to some patient's scar outcomes for donor sites. This study protocol outlines a randomised controlled trial designed to test the effectiveness of this treatment on reducing scarring to burn donor sites.
METHODS/DESIGN: This study is a single-centre, single (assessor)-blinded, randomised control trial in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post-operatively (on day 5). Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months.
This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a potentially cost-effective scar prevention for patients with donor sites to the thigh. No known studies of this nature have been carried out to date, and there is a need for rigorous clinical evidence for low-pressure support garments for donor site scar minimisation.
Australian New Zealand Clinical Trials Registry identifier ACTRN12610000127000 . Registered 8 Mar 2010.
压力衣疗法（PGT）在烧伤瘢痕和植皮治疗中已被临床医生广泛接受并普遍使用。这些压力衣产生的中到高压力（24 - 40毫米汞柱）有助于使瘢痕最小化，并且已有充分的证据证明其在这一特定应用中的有效性。然而，专门用于烧伤供皮区的压力衣疗法（供皮区同样会形成瘢痕）却缺乏充分的文献记载。本研究方案旨在调查低压（4 - 6毫米汞柱）临时压力衣对供皮区愈合及瘢痕形成的影响。临时压力衣（IPG）的主要作用似乎是固定供皮区敷料，但其作用似乎是双重的。用于供皮区的IPG使用方式并不一致，其重点在于固定伤口敷料而非瘢痕管理。然而，一些传闻和观察证据表明，IPG对某些患者供皮区的瘢痕形成结果也有影响。本研究方案概述了一项随机对照试验，旨在测试这种治疗方法对减少烧伤供皮区瘢痕形成的有效性。
方法/设计：本研究是一项针对大腿部有烧伤供皮区患者的单中心、单（评估者）盲、随机对照试验。患者将被随机分配至对照组（供皮区不施加压力）或实验组（供皮区施加压力）作为对照治疗。将在基线时比较两组患者的重要预后指标：供皮区位置、深度、大小、年龄以及植皮后的时间（5天）。IPG治疗将在术后（第5天）进行。每两周进行一次随访评估并更换压力衣，为期2个月。
本研究聚焦于烧伤瘢痕管理的一个独特领域，即使用低压管状支撑压力衣来减少供皮区瘢痕。专门针对供皮区瘢痕管理的此类疗法在文献中报道较少。本研究旨在测试一种对大腿部有供皮区的患者可能具有成本效益的瘢痕预防方法。迄今为止，尚未开展过此类性质的已知研究，并且需要有关于低压支撑压力衣减少供皮区瘢痕的严格临床证据。
澳大利亚新西兰临床试验注册中心标识符ACTRN12610000127000。于2010年3月8日注册。
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