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.
The primary objective of this prospective, non-randomized, controlled study is to assess the safety of the human amnion membrane powder for enhanced wound healing properties in patients undergoing Mohs surgery resulting in full thickness wounds. The secondary objective is to evaluate the efficacy of the product relative to the standard of care treatment in a control cohort of subjects. The treatment site will be the wound created by the Mohs surgery in the treatment group. The proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery
aquaphor ointment applied during MOHS scalp surgery
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Number of Participants with Infection
Number of participants that developed a wound infection
Time frame: Through week 16
Number of Participants with Allergic Reaction
Number of participants with an allergic reaction to the intervention
Time frame: Through week 16
Number of Treatment-Related Adverse Events
Number of treatment-related adverse events
Time frame: Through week 16
Number of Unscheduled Visits for Wound Bleeding
Number of participants that had an unscheduled visit for wound bleeding
Time frame: Through week 16
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Baseline
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 1
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 2
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 3
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 4
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 5
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 6
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 7
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 8
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 12
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Time frame: Week 16
Time Until Wound Closure
Number of days until wound was completely closed
Time frame: Through week 16
Time Until of Wound Closure
Number of days until wound was fully sealed
Time frame: Through week 16
Percentage of Re-epithelialization
Percentage of the wound with re-epithelialization
Time frame: Week 1, week 4, week 8, week 12, week 16