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

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00196508
First received: September 13, 2005
Last updated: October 13, 2007
Last verified: June 2006
  Purpose

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.


Condition Intervention Phase
Episiotomy
Perineal Tear
Device: High Viscosity DERMABOND
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 118
Study Start Date: April 2005
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196508

Locations
United States, Alabama
Bessemer, Alabama, United States, 35021
United States, New Jersey
Phoenix OB-GYN Associates
Moorestown, New Jersey, United States, 08057
United States, Tennessee
McDonald Murrmann Women's Clinic
Memphis, Tennessee, United States, 38120
United States, Virginia
Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502
Virginia Beach Obstetrics & Gynecology
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Ethicon, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00196508     History of Changes
Other Study ID Numbers: 200-04-001
Study First Received: September 13, 2005
Last Updated: October 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Ethicon, Inc.:
Childbirth

ClinicalTrials.gov processed this record on November 20, 2014