A Study to Determine the Safety of PEP in Skin Graft Wounds

Overview

About this study

The purpose of this study is to evaluate the safety of PEP in skin graft wounds.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Males and females 18 years of age or older.
  • Requiring at least two 20-40cm2 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 20-40cm^2 (but can be up to 90 cm^2 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.
  • 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 mile 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.

Eligibility last updated 2/2/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Steven Moran, M.D.

Open for enrollment

Contact information:

Sheri Ramaker R.N.

(507) 538-6984

ramaker.sheri@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20508610

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