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

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00196508
Collaborator
(none)
118
Enrollment
5
Locations
9
Duration (Months)
23.6
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High Viscosity DERMABOND
 Phase 3

Study Design

Study Type:
Interventional
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
Study Start Date :
Apr 1, 2005
Study Completion Date :
Jan 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth []

  2. The incidence of perineal skin opening requiring re-closure post-partum []

Secondary Outcome Measures

  1. Presence and extent of clinically relevant skin openings []

  2. Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area []

  3. Perineal skin closure cosmesis []

  4. Patient satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Bessemer Alabama United States 35021
2 Phoenix OB-GYN Associates Moorestown New Jersey United States 08057
3 McDonald Murrmann Women's Clinic Memphis Tennessee United States 38120
4 Tidewater Physicians for Women Norfolk Virginia United States 23502
5 Virginia Beach Obstetrics & Gynecology Virginia Beach Virginia United States 23454

Sponsors and Collaborators

  • Ethicon, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00196508
Other Study ID Numbers:
  • 200-04-001
First Posted:
Sep 20, 2005
Last Update Posted:
Oct 16, 2007
Last Verified:
Jun 1, 2006
Keywords provided by , ,
Childbirth

Study Results

No Results Posted as of Oct 16, 2007