Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Delayed Injury/Scar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in scar contracture, as measured by change in scar surface area size
研究概览
简要总结
The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:
- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture?
Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk.
Participants will:
- Receive fat grafting at time of scar revision.
- Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.
详细描述
Soft-tissue injuries from blasts, burns, or multiple traumas can cause severe damage, leading to loss of function, lower quality of life, long recovery times, and inability to work. When these injuries involve deep burns or full-thickness tissue loss in areas that move a lot, they are especially difficult to treat due to the risk of scarring, stiffness, and tissue sticking together. There is a need for a reliable, single-stage treatment that can provide soft, flexible tissue reconstruction with minimal risk, cost, and, complexity. To address this issue, the investigators propose a fat-based approach to reconstruction. Fat tissue is easily available from the patient's own body and carries many benefits in reconstructive surgery. Our team has shown that using a layer of fat immediately in treatment creates a soft, vascular layer that reduces scarring, improves tissue volume, and supports a one-stage, multi-layer reconstruction without the need for complex surgery or causing harm to the donor area. The purpose of this study is to compare this reconstructive approach under the following conditions:
• Demonstrate non-inferiority of autologous layered composite grafting to full-thickness skin grafting for delayed reconstruction of post-burn/trauma scar contracture.
Evaluators including dedicated observers will be blinded to treatment group/strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The proposed study will include adult patients 18 years of age or older,
- •male or female,
- •civilian, military, active duty or retired veterans
- •presenting for scar contracture release and reconstruction at any level.
- •Additional inclusion criteria includes willingness to be randomized to receive a fat graft.
排除标准
- •Age < 18 years of age,
- •active infection,
- •medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety,
- •unwilling or unable to comply with study procedures,
- •radiation to the site of interest,
- •prisoners and/or vulnerable populations.
- •In addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.
研究组 & 干预措施
Delayed Full Thickness Skin Graft (FTSG) Reconstruction
In this Arm, the investigators will assess FTSGs for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a FTSG.
干预措施: Full Thickness Skin Graft (FTSG) (Procedure)
Delayed Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Graft)
In this Arm, the investigators will assess Autologous Layered Composite Grafting for reconstruction of defects after burn scar revision of the face, neck, or extremities. Participants will receive any release and/or preparation of the scar/wound bed as would be standard of care and will then receive reconstruction with a Autologous Layered Composite Graft.
干预措施: Base of wound fat graft with Split Thickness Skin Graft (STSG) Reconstruction (Autologous Layered Composite Grafting). (Procedure)
结局指标
主要结局
Change in scar contracture, as measured by change in scar surface area size
时间窗: From surgery to 9-month clinical endpoint.
Contracture as measured by change in surface area of reconstruction between time of surgery and 9-month clinical endpoint/maturation of reconstruction. These data will be derived by serial photography.
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).(From surgery to 9-month clinical endpoint.)
- Total score on the Patient and Observer Scar Assessment Scale (POSAS): Pigmentation, Pliability, Vascularity, Thickness, Relief, and Surface Area, collected at the 9 month follow up visit. Remove(From surgery to 9-month clinical endpoint.)
- Number of Operative Encounters(From surgery to 9-month clinical endpoint.)
- Percent Graft Take(From surgery to 9-month clinical endpoint.)
- Time to Final Healing/Graft Take(From surgery to 9-month clinical endpoint.)
- Tissue Thickness(From surgery to 9-month clinical endpoint.)
- Pliability (Tensiometry/Cutometry)(From surgery to 9-month clinical endpoint.)
- Tissue Adhesion/Mobility(From surgery to 9-month clinical endpoint.)
研究者
Francesco Egro
Director of Burn Reconstruction
University of Pittsburgh