NCT00196508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

October 16, 2007

Status Verified

June 1, 2006

First QC Date

September 13, 2005

Last Update Submit

October 13, 2007

Conditions

EpisiotomyPerineal Tear

Keywords

Childbirth

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • 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

Interventions

High Viscosity DERMABONDDEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Bessemer, Alabama, 35021, United States

Location

Phoenix OB-GYN Associates

Moorestown, New Jersey, 08057, United States

Location

McDonald Murrmann Women's Clinic

Memphis, Tennessee, 38120, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

Virginia Beach Obstetrics & Gynecology

Virginia Beach, Virginia, 23454, United States

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

April 1, 2005

Study Completion

January 1, 2006

Last Updated

October 16, 2007

Record last verified: 2006-06

Locations

US(5)