A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth

Ethicon, Inc.4 sites in 1 country118 target enrollmentApril 2005

ConditionsEpisiotomy Perineal Tear

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Episiotomy
Sponsor: Ethicon, Inc.
Enrollment: 118
Locations: 4
Primary Endpoint: Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

January 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ethicon, Inc.

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

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