Can a new dressing make skin graft donor sites less painful?
NCT ID NCT07734519
First seen Jul 29, 2026 · Last updated Aug 26, 2026 · Updated 4 times
Summary
This trial tests whether a new dressing called Pelashield reduces pain and improves scar appearance compared to the standard Xeroform dressing at skin graft donor sites. Each participant will have their donor site split in half, with one half receiving Pelashield and the other Xeroform, allowing direct comparison. The study enrolls adults undergoing split-thickness skin grafts and measures pain scores and scar quality over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pelashield dressing (a new skin graft donor-site dressing) compared to Xeroform dressing
- What this could lead to
- If Pelashield reduces pain or improves scar appearance, it could become a better option for people undergoing skin grafts.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. The new dressing might not be better than the standard one.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
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