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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07734519). StuddyBuddy aggregates publicly available trial information.