Pelashield vs Xeroform
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelashield, Xeroform.
- Who it may be relevant to
- Registry conditions: Skin Graft. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform
Overview
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).
Detailed description
A novel dressing (Pelashield) has been developed that provides wound coverage, incorporates silver for antimicrobial activity, and contains lidocaine for local analgesia. This dressing offers the potential for improved pain control, particularly for larger donor sites, and may facilitate outpatient management. However, because the dressing includes an absorbable film, there is potential for increased irritation or altered wound healing. To rigorously evaluate this product, this prospective randomized study is being done to assess both pain control and donor-site appearance outcomes. The patient will be used as their own control 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 (standard dressing used today). Patients will be blinded to treatment allocation. Outcome assessors for photographic evaluation will be blinded to treatment assignment. In patients with multiple donor sites, one donor site judged by the surgeon to be most suitable for standardized comparison will be selected as the study donor site.
Interventions
- Device Pelashield
Pelashield dressing will be applied to half of the skin graft donor site - Device Xeroform
Xeroform dressing will be applied to have of the skin graft donor site
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Patient and Observer Scar Assessment Scale [Time frame: Week 4, Month 3]
- Erythema Index [Time frame: Month 3]
- Melanin Index [Time frame: Month 3]
- Scar Tissue Compliance [Time frame: Month 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Atrium Health Wake Forest Baptist — Winston-Salem
Identifiers
NCT: NCT07734519 · IRB00147578