Pelashield vs Xeroform for donor-site dressings in skin graft patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 trial compares Pelashield to Xeroform for donor-site dressings in patients undergoing split-thickness skin grafts. Each participant acts as their own control, receiving Pelashield on one half of the donor site and Xeroform on the other half, with blinding of the patient and blinded outcome assessors. The study evaluates pain outcomes and donor-site appearance during early healing, using standardized photography and follow-up visits. Eligible participants must have donor sites large enough for two comparable halves and be able to comply with the protocol. The trial is conducted at a single center under Wake Forest University Health Sciences with Atrium Health Wake Forest Baptist as the site.

Why it matters

Who can join: the full rules

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

Where it's running

• Atrium Health Wake Forest Baptist
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: John K. Bailey, MD — Atrium Health Wake Forest Baptist
• Study coordinator: D'Ann Hershel
• Email: dann.hershel@advocatehealth.org
• Phone: 336-716-1659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.