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The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human dehydrated amnion/chorion allofraft | Experimental | Closed hemorrhoidectomy patched with human dehydrated amnion chorion allograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human dehydrated amnion chorion allograft | Other | Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reported Patient Pain | The primary endpoint of the study is the change in patient reported pain across four categories from baseline within the 60 day follow-up period. In every patient diary, subjects will be asked to assess their pain on a 10 point Likert scale under the following conditions
| 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Fetterolf, MD | MiMedx Group, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder Valley Surgical Associates | Boulder | Colorado | 80303 | United States |
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