Pelashield vs Xeroform

Официальное название

A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство Pelashield
  Pelashield dressing will be applied to half of the skin graft donor site
• Устройство Xeroform
  Xeroform dressing will be applied to have of the skin graft donor site

Первичные конечные точки

• Pain Score [Срок оценки: Hour 1]
• Pain Score [Срок оценки: Hour 4]
• Pain Score [Срок оценки: Hour 8]
• Pain Score [Срок оценки: Hour 12]
• Pain Score [Срок оценки: Hour 24]

Вторичные конечные точки (4)

• Patient and Observer Scar Assessment Scale [Срок оценки: Week 4, Month 3]
• Erythema Index [Срок оценки: Month 3]
• Melanin Index [Срок оценки: Month 3]
• Scar Tissue Compliance [Срок оценки: Month 3]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Atrium Health Wake Forest Baptist — Winston-Salem

Идентификаторы

NCT: NCT07734519 · IRB00147578

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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