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

NCT ID: NCT00196508

Last Updated: 2007-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Episiotomy Perineal Tear

Keywords

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Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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High Viscosity DERMABOND

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Bessemer, Alabama, United States

Site Status

Phoenix OB-GYN Associates

Moorestown, New Jersey, United States

Site Status

McDonald Murrmann Women's Clinic

Memphis, Tennessee, United States

Site Status

Tidewater Physicians for Women

Norfolk, Virginia, United States

Site Status

Virginia Beach Obstetrics & Gynecology

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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200-04-001

Identifier Type: -

Identifier Source: org_study_id