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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:
ClinicalTrials.gov Identifier:
NCT00196508
First Posted: September 20, 2005
Last Update Posted: October 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ethicon, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00196508     History of Changes
Other Study ID Numbers: 200-04-001
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 16, 2007
Last Verified: June 2006

Keywords provided by Ethicon, Inc.:
Childbirth