Pelashield vs Xeroform

Phase 4Not Yet RecruitingNCT07734519

Wake Forest University Health Sciences40 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Skin Graft

Interventions

PelashieldDEVICE

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

XeroformDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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.

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

D'Ann Hershel

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Patient and Observer Scar Assessment Scale

Patient and Observer Scar Assessment Scale (POSAS): Total score 6-60. Lower scores indicate scar characteristics more similar to normal skin; higher scores indicate poorer scar quality.

Time frame: Week 4, Month 3

Erythema Index

Erythema will be measured using the Mexameter. The device generates a reading in arbitrary instrument units (AU) also referred to as index units. Total range is 0 to 999. Higher erythema index values indicate greater redness of the skin.

Time frame: Month 3

Melanin Index

Melanin will be measured using the Mexameter. The device generates a reading in arbitrary instrument units (AU) also referred to as index units. Total range is 0 to 999. Higher melanin index values indicate greater concentration of melanin pigment in the skin.

Time frame: Month 3

Scar Tissue Compliance

Scar tissue compliance will be measured using suction-based deformation testing (BTC-2000). Compliance will be quantified as maximum tissue displacement (mm) in response to a standardized suction pressure. Greater displacement (mm) indicates greater tissue compliance (less stiffness).

Time frame: Month 3