PEP on a Skin Graft Donor Site Wound

• Status: Enrolling by invitation
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of a biological agent called PEP in people who have a skin graft donor site wound.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steven L. Moran
• Collaborator: Rion LLC
• Treatments: Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

• Males and females 18 years of age or older.

• Requiring at least two 40 cm^2 or larger split-thickness skin grafts by a Mayo Clinic plastic surgeon or dermatologist.

• Skin graft that meets all of the following criteria:

• Each graft site has a size of 40 cm^2 (7.6 cm x 5.26 cm);

• Located anywhere on the body (with exception of oral mucosal membranes);

• Split-thickness skin graft wound depth of between 8/1000-14/1000 inch.

• Ability to safely undergo skin graft harvest procedure.

• Capacity to provide informed consent

• Ability to comply with protocol.

• 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.

• Patient lives within 150 miles radius of study site and is able and willing to return to study site for all follow-up visits.

Exclusion Criteria:

• Actively undergoing cancer treatment.

• Known history of MRSA (methicillin-resistant staphylococcus aureus).

• Known hypersensitivity to aprotinin (Trasylol®).

• Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody or HIV.

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

• 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.

• Patients on systemic immunosuppression, or have systemic autoimmune or chronic inflammatory disease.

• Subjects with hepatic impairment.

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

• Patients with poorly controlled diabetes mellitus (HbA1C ≥ 8%).

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

• Currently on or planned to receive hyperbaric wound therapy.

• Pregnant or lactating female patients.

• Prisoners.