Amnion Membrane Powder Mohs Study
ConditionWound Heal
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
The purpose of this research study is to test the safety of the amnion membrane powder to see if it improves wound healing in patients undergoing Mohs surgery on the scalp.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Amnion Membrane Powder
- Standard of Care
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov