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The current protocol did not satisfy IRB requirements
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This is a comparison trial with novel application of AmnioFix and a control arm. Patients electively being treated with facial lasers will be assigned to receive AmnioFix in addition to the normal standard of care placed on half of their face after laser procedure, and normal post laser standard of care alone on the other half of their face. The investigators will investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic factors. The study is designed to compare AmnioFix to the current standard of laser care.
AmnioFix is a dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. Amniotic membrane is a unique material and its composition contains collagen types I, III, IV, V, and VII. Amniotic membrane is composed of structural extracellular matrix (ECM), that also contains specialized proteins fibronectin, laminins, proteoglycans and glycosaminoglycans. In addition, amniotic membrane contains essential, active, healing growth factors such as epidermal growth factor (EGF), transforming growth factor beta (TGF-b), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF).
The study is designed to compare AmnioFix to the current standard of laser care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care plus AmnioFix | Other | All patients will receive the standard of care alone on half of their face, and AmnioFix in addition to the standard of care on the other half of their face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AmnioFix plus Standard of Care | Device | Patients will receive the standard of care alone on half of their face, and AmnioFix in addition to the standard of care on the other half of their face. The standard of care after ablative resurfacing is conservative wound care which may include flexible wound care dressings and/or emollients. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of reepithelialization | Subjects' healing and recovery is the primary outcome measure. Reepithelialization will be assessed at each follow up visit, considering the following: erythema, edema/induration, and oozing/drainage. | 28 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Dermatology | San Francisco | California | 94115 | 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 | Procedure | Patients will receive the standard of care dressing only, on their face. The standard of care after ablative resurfacing is conservative wound care which may include flexible wound care dressings and/or emollients. |
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