Autologous Point-of-Care Adipose Therapy for Reconstruction and Regeneration of Traumatized Skin: Recent Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are:
- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction?
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 immediate fat grafting into the wound.
- 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 efficacy of immediate autologous adipose and autologous layered Composite Grafting in acute functional soft-tissue reconstruction.
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 unilateral or bilateral fasciotomy of the extremity at any level necessary
- •secondary to non-infectious etiology,
- •unilateral or bilateral traumatic full-thickness skin loss of the face, head, neck or extremities necessitating reconstruction, and/or
- •full or partial thickness burn injury of the face, neck, or extremity requiring excision and/or reconstruction.
- •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
Acute Split Thickness Skin Graft (STSG) Reconstruction
In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by immediate STSG.
干预措施: Split Thickness Skin Graft (STSG) (Procedure)
Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting).
In this Arm, the investigators will evaluate full thickness defects generated after fasciotomy, trauma debridement, and/or burn excision of the face, neck, or extremities. These wounds represent common, full-thickness injuries, which require prolonged recovery and dressing changes as bridge to either skin graft or delayed closure and commonly are associated with contour irregularities, adhesions, and contracture. The investigators will assess current standard of care dressing changes followed by base of wound fat graft with STSG reconstruction (Autologous Layered Composite Grafting).
干预措施: Base of wound fat graft with STSG Reconstruction (Autologous Layered Composite Grafting). (Procedure)
结局指标
主要结局
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.
时间窗: From surgery to 9-month clinical endpoint.
POSAS measures subjective assessment on a 1-10 scale from normal skin to worst scar imaginable across 6 metrics (surface area, vascularity, pigmentation, thickness, pliability and relief). The lowest sum score, reflecting normal skin, is 6 and the highest score, reflecting the worst imaginable scar, is 60.
次要结局
- Photographic Appearance of Wound(From surgery to 9-month clinical endpoint.)
- Area of Wound(From surgery to 9-month clinical endpoint.)
- Tissue Thickness(From surgery to 9-month clinical endpoint.)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).(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.)
- Pliability (Tensiometry/Cutometry)(From surgery to 9-month clinical endpoint.)
- Tissue Mobility (Resistance to Adhesion)(From surgery to 9-month clinical endpoint.)
研究者
Francesco Egro
Director of Burn Reconstruction
University of Pittsburgh