Recruiting

PelashieldTM vs. Xeroform

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07734519

Conditions

Skin Graft

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelashield

Xeroform

Study Details

Brief 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).

Conditions

Skin Graft

Study ID

NCT07734519

Start date

Sep 30, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pelashield

Pelashield skin graft dressing

active comparator: Xeroform

standard of care skin graft dressing

Interventions

Pelashield

Pelashield dressing will be applied to half of the skin graft donor site

Xeroform

Xeroform dressing will be applied to have of the skin graft donor site

Primary outcome measure

  • Pain Score [ Time Frame: Hour 1 ]
  • Pain Score [ Time Frame: Hour 4 ]
  • Pain Score [ Time Frame: Hour 8 ]
  • Pain Score [ Time Frame: Hour 12 ]
  • Pain Score [ Time Frame: Hour 24 ]

Central Contacts and Locations

Central contacts

D'Ann Hershel

336-716-1659dann.hershel@advocatehealth.org

Locations

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

D'Ann Hershel

336-716-1659dann.hershel@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 1, 2026

Last verified

Jul, 2026

Keywords

  • Pelashield
  • Xeroform
  • donor site pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.