A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
The purpose of this research study is to compare the effects (good or bad) of a new skin graft dressing (PelashieldTM) compared to the one traditionally used (Xeroform).
详细描述
A novel dressing (Pelashield) has been developed that provides wound coverage, incorporates silver for antimicrobial activity, and contains lidocaine for local analgesia. This dressing offers the potential for improved pain control, particularly for larger donor sites, and may facilitate outpatient management. However, because the dressing includes an absorbable film, there is potential for increased irritation or altered wound healing. To rigorously evaluate this product, this prospective randomized study is being done to assess both pain control and donor-site appearance outcomes. The patient will be used as their own control and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform (standard dressing used today). Patients will be blinded to treatment allocation. Outcome assessors for photographic evaluation will be blinded to treatment assignment. In patients with multiple donor sites, one donor site judged by the surgeon to be most suitable for standardized comparison will be selected as the study donor site.
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
- Double (Participant, 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
- •Undergoing split-thickness skin graft harvest, with a donor site sufficiently large to allow division into two comparable halves for randomized dressing application.
- •Donor site located in an area amenable to standardized photography and serial appearance assessment.
- •Ability to provide informed consent.
- •Willingness and ability to participate in scheduled follow-up visits for donor-site assessment, including standardized photography.
- •Donor-site management expected to follow the standardized study dressing protocol for the duration of the early healing period.
排除标准
- •Inability, or anticipated inability, to reliably report pain within 1hour (or in recovery room) after surgery
- •Known allergy or hypersensitivity to lidocaine, silver-containing dressings, or other components of the study dressings.
- •Donor sites that are too small, irregularly shaped, or anatomically unsuitable to allow division into two comparable treatment halves.
- •Pre-existing skin disease at or adjacent to the donor-site region that may affect wound healing or scar appearance
- •Clinical situations in which the treating surgeon anticipates that protocol-based donor-site care cannot be maintained, including cases requiring non-standard dressings or adjunctive local therapies.
- •Anticipated inability to complete follow-up assessments, including inability to obtain evaluable standardized photographs at key time points.
- •Severe uncontrolled systemic conditions likely to significantly impair wound healing, at the discretion of the investigator (e.g., severe immunosuppression or other conditions making reliable donor-site healing unlikely).
- •Allergy to any local anesthetic
- •Allergy or sensitivity to silver
- •Pregnancy
研究组 & 干预措施
Xeroform
standard of care skin graft dressing
干预措施: Xeroform (Device)
结局指标
主要结局
Pain Score
时间窗: Hour 1
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
时间窗: Hour 4
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
时间窗: Hour 8
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
时间窗: Hour 12
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
时间窗: Hour 24
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
次要结局
- Patient and Observer Scar Assessment Scale(Week 4, Month 3)
- Erythema Index(Month 3)
- Melanin Index(Month 3)
- Scar Tissue Compliance(Month 3)