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

Phase 3

Completed

• Conditions: Episiotomy; Perineal Tear

• Registration Number: NCT00196508
• Lead Sponsor: Ethicon, Inc.

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 sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-01
• Status Verified: 2006-06
• Last Update Submitted: 2007-10-13
• Last Update Posted: 2007-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of perineal skin opening requiring re-closure post-partum
Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth

Secondary Outcome Measures

Name	Time	Method
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
Perineal skin closure cosmesis
Patient satisfaction

Trial Locations

Locations (4)

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