Trials / Completed
CompletedNCT00196508
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 118 (planned)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | High Viscosity DERMABOND |
Timeline
- Start date
- 2005-04-01
- Completion
- 2006-01-01
- First posted
- 2005-09-20
- Last updated
- 2007-10-16
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00196508. Inclusion in this directory is not an endorsement.