Amnion Wound Covering for Enhanced Wound Healing

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.

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

Details

• Lead Sponsor: Wake Forest University Health Sciences

Criteria

Inclusion Criteria:

• The subject requires autologous primary skin graft with two donor sites in similar areas, each measuring at least 25 cm2 with the likely depth of 0.012 inches and separated by a 5 cm gap. It is preferable that the two sites be on right and left sides of the body, but it is not an exclusion if they must be on the same side.

• Eligible primary wound sites may be traumatic or chronic, and will be at least 50 cm2 (that will receive the donor graft) to allow assessment of two separate experimental donor sites of 25 cm2.

• The subject is between the ages of 18 and 85 years of age.

• The subject is willing to complete all follow-up evaluations required by the study protocol.

• The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless medically necessary.

• The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.

• The subject and/or guardian is able to read and understand instructions and give informed, voluntary, written consent.

• The subject is able and willing to follow the protocol requirements

Exclusion Criteria:

• The subject's primary wound site is less than 50 cm2The subject's primary wound site is not deemed appropriate for skin graft based upon the investigator's clinical experience

• The subject has a microbiologically proven pre-existing local or systemic bacterial infection.

• The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.

• Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure.

• Hepatic disease or altered liver function as defined by ALT or AST value >3 times the upper limit of normal and/or T. Bilirubin >1.5 mg/dL at screening

• Renal disease or altered renal function as defined by serum creatinine > 2 mg/dL at screening, or end-stage renal disease.

• Hemoglobin <10.0 or >19.0 g/dL

• Known coagulopathy or platelet disorder, or INR > 1.6 , PTT > 38 sec; PLT < 50,000 at screening

• The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with wound healing including but not limited to: current malignancy, uncontrolled diabetes (HbA1c >8) or diabetic ulcers, autoimmune disease or other immunocompromised diseases, renal impairment or ESRD, liver disease, hematological