Status:
UNKNOWN
PEP on a Skin Graft Donor Site Wound
Lead Sponsor:
Rion Inc.
Collaborating Sponsors:
ProPharma Group
Conditions:
Skin Graft
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Main Criteria for Inclusion:
- Males and females 18-75 years of age.
- Requiring at least two 20-40 cm2 split-thickness skin grafts by a licensed surgeon or dermatologist
- Skin graft that meets all the following criteria:
- 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)
- Located anywhere on the body (with exception of oral mucosal membranes)
- Split-thickness skin graft wound depth of between 8/1000-14/1000 inch
- Study donor sites are ≥ 1 cm apart
- 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
- Subject is able and willing to return to study site for all follow-up visits
- Main Criteria for Exclusion:
- 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)
- 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 human immunodeficiency virus (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
- Participation in another interventional clinical study or trial in the past 30 days or concurrent participation in another interventional clinical study or trial
- Subjects with poorly controlled diabetes mellitus (Hemoglobin A1c \[HbA1c\] ≥ 8%)
- Subjects with known peripheral neuropathy, or known concomitant vascular problems (such as peripheral artery disease, arterial insufficiency, or venous hypertension) or calciphylaxis
- Subjects with burns covering ≥ 30% of Total Body Surface Area
- Currently on or planned to receive hyperbaric wound therapy
- Pregnant or lactating female subjects
- Sexually active woman of childbearing potential who is unwilling to use approved contraception method for 3 months after receiving dose of investigational drug
- Prisoners
Exclusion
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04664738
Start Date
March 16 2021
End Date
February 2 2024
Last Update
September 8 2023
Active Locations (2)
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1
International Research Partners
Doral, Florida, United States, 33122
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905