Pelashield vs Xeroform

NCT07734519 | Not Yet Recruiting Phase 4 FDA Device

• 1 other identifier: IRB00147578
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Pelashield; Xeroform; donor site pain

Outcome Measures

Primary Outcomes (5)

• Pain Score

  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.

  Hour 1

• Pain Score

  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.

  Hour 4

• Pain Score

  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.

  Hour 8

• Pain Score

  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.

  Hour 12

• Pain Score

  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.

  Hour 24

Secondary Outcomes (4)

• Patient and Observer Scar Assessment Scale

  Week 4, Month 3

• Erythema Index

  Month 3

• Melanin Index

  Month 3

• Scar Tissue Compliance

  Month 3

Study Arms (2)

Pelashield

EXPERIMENTAL

Pelashield skin graft dressing

Device: Pelashield

Xeroform

ACTIVE COMPARATOR

standard of care skin graft dressing

Device: Xeroform

Interventions

Pelashield DEVICE

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

Pelashield

Xeroform DEVICE

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

Xeroform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• John K. Bailey, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

D'Ann Hershel

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)