Status:
COMPLETED
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
Lead Sponsor:
Ethicon, Inc.
Conditions:
Episiotomy
Perineal Tear
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Patient is at least 18 years of age.
- Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.
- Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.
- Patient has signed the informed consent form.
Exclusion
- Patient has peripheral vascular disease.
- Patient has insulin dependent diabetes mellitus.
- Patient has a blood clotting disorder that requires therapy.
- Patient has a personal or family history of keloid formation or hypertrophy.
- Patient has a known allergy to cyanoacrylates or formaldehyde.
- Patient has impaired wound healing by history. Patient is a chronic steroid user.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00196508
Start Date
April 1 2005
End Date
January 1 2006
Last Update
October 16 2007
Active Locations (5)
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1
Bessemer, Alabama, United States, 35021
2
Phoenix OB-GYN Associates
Moorestown, New Jersey, United States, 08057
3
McDonald Murrmann Women's Clinic
Memphis, Tennessee, United States, 38120
4
Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502