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临床试验/NCT02947737
NCT02947737已完成不适用

Investigating the Effects of Amniotic Membrane on Donor Site Healing and Postoperative Pain

Emory University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Change in postoperative pain

研究概览

简要总结

The purpose of this study is to compare the effectiveness of applying amniotic membrane dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. This study will enroll ten participants who undergoing a split thickness skin graft procedure with two or more donor sites. The amniotic membrane will be applied to one donor site and a dressing of xeroform and gentamicin will be applied to another other donor site. Each participant will receive both types of dressing and will serve as their own control. Postoperative follow up will follow standard of care, regardless of the dressing type. Dressings will be removed on postoperative day 4 and participants will return to be re-examined one week after being discharged from the hospital.

详细描述

The use of amniotic membrane in the treatment of wounds has been employed for almost 100 years, with reports of it being used in skin grafting for burns and ulcers in 1913. This study will investigate the use of amniotic membrane as a donor site dressing (the area where skin is removed to be transplanted to the recipient site). Donor sites are often a significant cause of postoperative pain for patients who have undergone skin grafts. Furthermore, donor sites that fail to re-epithelialize or scar may require additional excision and skin grafting on the donor site itself. There is a paucity of literature in the United States regarding the use of amniotic membrane as a donor site dressing, however, studies from other countries have demonstrated an increase in patient comfort and a faster time to re-epithelialization. Inherent to amniotic membrane that makes it an ideal dressing include the presence of extracellular matrix components create integrity, epithelial cells participate in the healing process, and defensins confer antibacterial properties. MiMedx produces AmnioFix® which is a dehydrated preserved amniotic membrane that will be used in the dressing of our donor sites in contrast to gentamicin and xeroform based dressings. This study will see if patients have improved cosmetic outcomes, less postoperative pain and a faster time to re-epithelialization at the donor site treated with amniotic membrane compared to the standard of care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing a split thickness skin graft procedure with two or more donor sites

排除标准

  • less than 18 years of age

结局指标

主要结局

Change in postoperative pain

时间窗: Postoperative days 1, 2 and 5

Participants will report their pain level for each donor site as a numeric score from 1 to 10.

Change in re-epithelialization

时间窗: Postoperative days 2 and 5

The percent of re-epithelialization for each donor site will be evaluated by burn unit surgeons on postoperative days 2 and 5.

Comparison of scarring between donor sites

时间窗: Postoperative day 5

Scarring on postoperative day 5 will be evaluated by burn unit surgeons

Comparison of hypopigmentation between donor sites

时间窗: Postoperative day 5

Hypopigmentation on postoperative day 5 will be evaluated by burn unit surgeons.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachael Williams

Assistant Professor

Emory University

研究点 (2)

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