Amnion Membrane Powder Mohs Study

Inclusion Criteria:

• The subject requires Mohs surgery on the scalp, with the resulting wound extending to the subgalea (all subcutaneous fat removed) and a surface area of at least 4cm2.
• 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 otherwise directed by the study surgeon or their surrogate
• 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/are 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 wound site is smaller than 4cm2.
• The subject's wound site does not extend to the subgalea.
• The subject has invasive melanoma or high-risk squamous cell carcinoma (defined by poor differentiation, presence of perineural invasion) in which the standard of care is to be referred for adjuvant radiation oncology
• 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 that would preclude the indicated 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 ESRD.
• Hemoglobin <10.0 or >19.0 g/dL
• Untreated 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 complete re-epithelialization including but not limited to untreated malignancy, uncontrolled diabetes (HbA1c >10), autoimmune disease or other immunocompromised diseases, hematological diseases, peripheral artery diseases, and /or malnourishment with an albumin < 2.5.
• The subject currently uses illicit substances or has drug or alcohol dependency.
• The subject is unable to follow the protocol.
• The subject is taking medication known to have an effect on wound healing or skin pigmentation within 30 days prior to surgery (e.g. corticosteroids, retinoids etc.)
• The subject has a known hypersensitivity to Compound Sodium Lactate for Irrigation (Hartmann's) solution.
• The subject is pregnant or lactating or intends to become pregnant during the study.
• The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.