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

This study has been completed.

First Received: September 13, 2005 Last Updated: October 13, 2007 History of Changes

Sponsored by:	Ethicon, Inc.
Information provided by:	Ethicon, Inc.
ClinicalTrials.gov Identifier:	NCT00196508

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Virginia Beach Obstetrics & Gynecology
Virginia Beach, Virginia, United States, 23454
Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Ethicon, Inc.

More Information

No publications provided

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

Keywords provided by Ethicon, Inc.:

Childbirth

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on May 07, 2009