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Not Yet Recruiting
NCT07734519
Pelashield vs Xeroform
Conditions: Skin Graft
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Wake Forest University Health Sciences
Location: Atrium Health Wake Forest Baptist Winston-Salem North Carolina
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07734519). StuddyBuddy aggregates publicly available trial information.