A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth

Completed · Phase 3

Conditions studied: Episiotomy, Perineal Tear

In brief

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.

Key facts

Study ID

NCT00196508

Run by

Ethicon, Inc.

People needed

118

Starts

2005-04-01

Expected to finish

2006-01-01

Last updated by the study team

2007-10-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Bessemer, Alabama, United States
• Phoenix OB-GYN Associates — Moorestown, New Jersey, United States
• McDonald Murrmann Women's Clinic — Memphis, Tennessee, United States
• Tidewater Physicians for Women — Norfolk, Virginia, United States
• Virginia Beach Obstetrics & Gynecology — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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