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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amnion Membrane Powder | Experimental | amnion membrane power applied during MOHS scalp surgery |
|
| Standard of Care | Active Comparator | aquaphor ointment applied during MOHS scalp surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amnion Membrane Powder | Drug | amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Infection | Number of participants that developed a wound infection | Through week 16 |
| Number of Participants with Allergic Reaction | Number of participants with an allergic reaction to the intervention | Through week 16 |
| Number of Treatment-Related Adverse Events | Number of treatment-related adverse events | Through week 16 |
| Number of Unscheduled Visits for Wound Bleeding | Number of participants that had an unscheduled visit for wound bleeding | Through week 16 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Baseline |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 1 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 2 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Until Wound Closure | Number of days until wound was completely closed | Through week 16 |
| Time Until of Wound Closure | Number of days until wound was fully sealed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary-Clare Day | Contact | 336-713-1343 | Maryclare.Day@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Christine Ahn, MD | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Drug | aquaphor ointment applied during MOHS scalp surgery |
|
| Week 3 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 4 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 5 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 6 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 7 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 8 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 12 |
| Pain Score | Participants asked rate their pain on a scale of 1-10 with 10 being worst pain. | Week 16 |
| Through week 16 |
| Percentage of Re-epithelialization | Percentage of the wound with re-epithelialization | Week 1, week 4, week 8, week 12, week 16 |