PEP on a Skin Graft Donor Site Wound

NCT ID: NCT04664738

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2024-02-02

Brief 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.

Conditions

Skin Graft

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

10 % PEP only

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

Group Type: EXPERIMENTAL

10% PEP

Intervention Type: BIOLOGICAL

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

20% PEP only

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

Group Type: EXPERIMENTAL

20% PEP

Intervention Type: BIOLOGICAL

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

20% PEP and TISSEEL

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

Group Type: EXPERIMENTAL

TISSEEL

Intervention Type: DRUG

Fibrin sealant made from pooled human plasma

20% PEP

Intervention Type: BIOLOGICAL

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

Interventions

10% PEP

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

Intervention Type: BIOLOGICAL

TISSEEL

Fibrin sealant made from pooled human plasma

Intervention Type: DRUG

20% PEP

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

Intervention Type: BIOLOGICAL

Other Intervention Names

fibrin sealant

Eligibility Criteria

Inclusion Criteria

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

6. Ability to comply with protocol

7. Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests

8. Subject is able and willing to return to study site for all follow-up visits

Main Criteria for Exclusion:

1. Actively undergoing chemotherapy treatment (localized radiation treatment is allowed if it is not on the skin graft donor site and no active cancer is present)

2. Known history of MRSA (methicillin-resistant Staphylococcus aureus)

3. Known hypersensitivity to aprotinin (Trasylol®)

4. Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody or human immunodeficiency virus (HIV)

5. Any known allergy or sensitivity to adhesive dressings (e.g., Tegaderm)

6. Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study

7. Participation in another interventional clinical study or trial in the past 30 days or concurrent participation in another interventional clinical study or trial

8. Subjects with poorly controlled diabetes mellitus (Hemoglobin A1c [HbA1c] ≥ 8%)

9. Subjects with known peripheral neuropathy, or known concomitant vascular problems (such as peripheral artery disease, arterial insufficiency, or venous hypertension) or calciphylaxis

10. Subjects with burns covering ≥ 30% of Total Body Surface Area

11. Currently on or planned to receive hyperbaric wound therapy

12. Pregnant or lactating female subjects

13. Sexually active woman of childbearing potential who is unwilling to use approved contraception method for 3 months after receiving dose of investigational drug

14. Prisoners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ProPharma Group

INDUSTRY

Sponsor Role: collaborator

Rion Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Sabbah, MD

Role: STUDY_DIRECTOR

Rion Inc.

Locations

International Research Partners

Doral, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://riontx.com/

Rion company website

Other Identifiers

18-004995

Identifier Type: OTHER

Identifier Source: secondary_id

PRO-00068

Identifier Type: -

Identifier Source: org_study_id