Comparing Pelashield and Xeroform Dressings for Skin Grafts

This study is comparing a new skin graft dressing called Pelashield to a standard dressing called Xeroform. If you are having a split-thickness skin graft (where a thin layer of skin is taken from one area to cover another), and your donor site (where the skin is taken from) is large enough, you might be able to join. The study wants to see if Pelashield helps with pain better and how it affects the appearance of the donor site compared to Xeroform. Researchers will measure your pain at 1, 4, and 8 hours after the dressing is applied. The study plans to enroll 40 people, but its current status is unclear.

Study design
This is a randomized study where you will be your own control. Half of your skin graft donor site will receive Pelashield and the other half will receive Xeroform, and you won't know which is which.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain will be measured at 1, 4, and 8 hours after dressing application.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07734519

Pelashield vs Xeroform

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~40 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:PelashieldXeroform

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Score
Measured over Hour 1
+4 more outcomes measured
Skin Graft
1 sites across 1 states
North Carolina1
  • John K. Bailey, MD · PRINCIPAL_INVESTIGATOR · Atrium Health Wake Forest Baptist

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Eligibility criteria

Inclusion

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

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
  • Pain ScoreHour 1

    The patient will serve as their own control and 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. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.

  • Pain ScoreHour 4

    The patient will serve as their own control and 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. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.

  • Pain ScoreHour 8

    The patient will serve as their own control and 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. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.

  • Pain ScoreHour 12

    The patient will serve as their own control and 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. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.

  • Pain ScoreHour 24

    The patient will serve as their own control and 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. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.