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PEP on a Skin Graft Donor Site Wound

NCT04664738 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-09-08

No results posted yet for this study

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.

Conditions

  • Skin Graft

Interventions

BIOLOGICAL

10% PEP

PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.

DRUG

TISSEEL

Fibrin sealant made from pooled human plasma

BIOLOGICAL

20% PEP

PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.

Sponsors & Collaborators

  • ProPharma Group

    collaborator INDUSTRY

  • Rion Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Sabbah, MD · Rion Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2023-08-09
Completion
2024-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664738 on ClinicalTrials.gov