A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Had > 95 % Epithelialization at Day 10
研究概览
简要总结
The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well.
Treatment will be initiated in the operation room following debridement and split thickness grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be applied directly to study site. Secondary dressing will include covering with ace wrap.
Healing should be asses after 10-14 days.
详细描述
A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20 subjects from 2 centres in the US, presenting with the need for surgical intervention and grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site designated as a "study site".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical donor sites for deep partial-thickness or full-thickness burns
- •Burn of thermal origin
- •Both genders with an age ≥ 7 years at enrolment
- •Signed informed consent
- •Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.
排除标准
- •Any known or suspected systemic infection
- •Any known sensitivity to silver or other components/products used in this study.
- •Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a malignant disease in the past, was treated with the expectation of a cure and is currently disease-free, may be considered for study entry.
- •Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation.
- •Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
- •Requires immersion hydrotherapy at any time during study participation (note, showering hydrotherapy is allowed).
- •Subject unwilling to comply with 28 day follow-up.
- •Participation in another investigational study while participating in this study.
- •Bleeding disorders
研究组 & 干预措施
Mepilex Transfer Ag
Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
干预措施: Mepilex Transfer Ag (Device)
结局指标
主要结局
Percentage of Participants Who Had > 95 % Epithelialization at Day 10
时间窗: 10 days
次要结局
- Pain at Dressing Changes(28 days)