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

Perineal Tear Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196508
• Other study ID #: 200-04-001
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 13, 2007
• Start date: April 2005
• Est. completion date: January 2006

Study information

• Verified date: June 2006
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Episiotomy
• Perineal Tear

Intervention

Device:
• High Viscosity DERMABOND

Locations

Country	Name	City	State
United States	McDonald Murrmann Women's Clinic	Memphis	Tennessee
United States	Phoenix OB-GYN Associates	Moorestown	New Jersey
United States	Tidewater Physicians for Women	Norfolk	Virginia
United States	Virginia Beach Obstetrics & Gynecology	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth
Primary	The incidence of perineal skin opening requiring re-closure post-partum
Secondary	Presence and extent of clinically relevant skin openings
Secondary	Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area
Secondary	Perineal skin closure cosmesis
Secondary	Patient satisfaction