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PEP on a Skin Graft Donor Site Wound | Clinical Trials | Clareo Health

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PEP on a Skin Graft Donor Site Wound

A Phase I Open-Label Trial to Determine the Safety of PEP on a Skin Graft Donor Site Wound

NCT04664738•Rion Inc.

Summary

The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds.

Detailed Description

This is an open label phase 1b study of PEP (a leukocyte depleted blood preparation derived from human U.S. sourced pooled apheresed platelets) in patients with at least two donor split-thickness skin graft wounds. One donor site will be treated with the standard post-operative dressing, while the other site will be treated with PEP or PEP+TISSEEL and covered with a standard dressing. TISSEEL is a commercially available fibrin sealant.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Main Criteria for Inclusion:
•1. Males and females 18-75 years of age.
•2. Requiring at least two 20-40 cm2 split-thickness skin grafts by a licensed surgeon or dermatologist
•3. Skin graft that meets all the following criteria:
•1. Each graft site has a size of 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure)
•2. Located anywhere on the body (with exception of oral mucosal membranes)
•3. Split-thickness skin graft wound depth of between 8/1000-14/1000 inch
•4. Study donor sites are ≥ 1 cm apart
•4. Ability to safely undergo skin graft harvest procedure
•5. Capacity to provide informed consent
+18 more criteria

Locations (2)

International Research Partners

Doral, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

March 16, 2021

Primary Completion Date

August 9, 2023

Completion Date

February 2, 2024

Last Updated

September 8, 2023

Enrollment

ACTUAL participants

Conditions

Skin Graft

Interventions

10% PEP

BIOLOGICAL

TISSEEL

DRUG

20% PEP

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PEP on a Skin Graft Donor Site Wound

Inclusion Criteria

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