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Biological Therapeutic

PEP for Skin Graft Donor Site Wounds

Phase 1

Waitlist Available

Led By Steven Moran, MD

Research Sponsored by Rion Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study donor sites are ≥ 1 cm apart

Requiring at least two 20-40 cm2 split-thickness skin grafts by a licensed surgeon or dermatologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test the safety of a new biological agent, PEP, on people with skin graft donor site wounds.

Who is the study for?

Adults aged 18-75 needing skin grafts can join this trial. They must be healthy, not pregnant or breastfeeding, and not have allergies to certain medical products like aprotinin or adhesive dressings. Participants should not have severe diseases, active cancer treatments except localized radiation away from the graft site, significant burns, infections like MRSA, HIV, hepatitis B/C or poorly controlled diabetes.Check my eligibility

What is being tested?

The study tests the safety of PEP (a biological therapeutic) on skin graft donor wounds. Patients will receive either 10% PEP or 20% PEP along with TISSEEL (a fibrin sealant) to see how well they heal compared to standard care.See study design

What are the potential side effects?

Possible side effects may include reactions at the application site such as redness, itching or swelling; allergic responses if sensitive to ingredients in PEP or TISSEEL; and general discomfort associated with wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You are able to safely have a procedure to remove a small piece of skin for transplantation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel

Maximum Tolerated Dose (MTD) of PEP / PEP-Tisseel

Secondary outcome measures

Long Term safety of PEP / PEP-Tisseel

Other outcome measures

Exploratory Endpoint

Side effects data

From 2020 Phase 2 trial • 15 Patients • NCT03276975

14%

Asymptomatic self-limited hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Simulated Patching Procedure

Targeted Epidural Patching of CSF Leaks With Autologous Blood and Fibrin Glue

Trial Design

3Treatment groups

Experimental Treatment

Group I: 20% PEP onlyExperimental Treatment1 Intervention

Cohort 2: Subjects will receive 20% PEP to the skin graft donor wound

Group II: 20% PEP and TISSEELExperimental Treatment2 Interventions

Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound.

Group III: 10 % PEP onlyExperimental Treatment1 Intervention

Cohort 1: Subjects will receive 10% PEP to the skin graft donor wound.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TISSEEL

2017

Completed Phase 2

~20

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rion Inc.Lead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

ProPharmaUNKNOWN

1 Previous Clinical Trials

42 Total Patients Enrolled

ProPharma GroupUNKNOWN

3 Previous Clinical Trials

77 Total Patients Enrolled

Media Library

10% PEP (Biological Therapeutic) Clinical Trial Eligibility Overview. Trial Name: NCT04664738 — Phase 1

Skin Grafting Research Study Groups: 10 % PEP only, 20% PEP only, 20% PEP and TISSEEL

Skin Grafting Clinical Trial 2023: 10% PEP Highlights & Side Effects. Trial Name: NCT04664738 — Phase 1

10% PEP (Biological Therapeutic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04664738 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has TISSEEL received governmental affirmation for its efficacy?

"The safety of TISSEEL is rated a 1 on the scale, as this Phase 1 trial has only limited evidence backing its efficacy and security."

Answered by AI

Could you elucidate what conditions TISSEEL is typically employed to treat?

"TISSEEL is a common solution for fibrinogen deficiency, yet it can also be utilized to control hemostasis, myringoplasty and other forms of bleeding."

Answered by AI

Are there remaining opportunities to partake in this research?

"As advertised on clinicaltrials.gov, this medical trial is not presently enrolling patients; the original posting for this research occurred on March 16th 2021 and the most recent edit was June 3rd 2022. Although no positions are available through this study, 19 other trials at different sites remain actively recruiting participants."

Answered by AI

How many participants are currently enrolled in this experiment?

"Unfortunately, this particular medical study is no longer recruiting. It was published on March 16th 2021 and last updated June 3rd 2022. Should you be seeking alternate research opportunities, there are currently 4 clinical trials related to skin grafts that welcome participants plus 15 studies utilizing TISSEEL in the approval process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PEP on a Skin Graft Donor Site Wound

Steven L. Moran 2021. "PEP on a Skin Graft Donor Site Wound". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04664738.