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This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Viscosity DERMABOND | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth | ||
| The incidence of perineal skin opening requiring re-closure post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Presence and extent of clinically relevant skin openings | ||
| Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bessemer | Alabama | 35021 | United States | |||
| Phoenix OB-GYN Associates |
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| Perineal skin closure cosmesis |
| Patient satisfaction |
| Moorestown |
| New Jersey |
| 08057 |
| United States |
| McDonald Murrmann Women's Clinic | Memphis | Tennessee | 38120 | United States |
| Tidewater Physicians for Women | Norfolk | Virginia | 23502 | United States |
| Virginia Beach Obstetrics & Gynecology | Virginia Beach | Virginia | 23454 | United States |