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CompletedNCT00196508Updated Oct 16, 2007

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

A Phase 3 interventional study of High Viscosity DERMABOND in Episiotomy and Perineal Tear, sponsored by Ethicon, Inc.. Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-16.

Sponsored by Ethicon, Inc. · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Episiotomy
  • Perineal Tear

Keywords

  • Childbirth
03

In context

Lead sponsor

Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants

Interventions

  • DeviceHigh Viscosity DERMABOND
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

5 sites
  • Bessemer, Alabama 35021, United States
  • Phoenix OB-GYN Associates
    Moorestown, New Jersey 08057, United States
  • McDonald Murrmann Women's Clinic
    Memphis, Tennessee 38120, United States
  • Tidewater Physicians for Women
    Norfolk, Virginia 23502, United States
  • Virginia Beach Obstetrics & Gynecology
    Virginia Beach, Virginia 23454, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00196508
Lead sponsor
Ethicon, Inc.
First posted
Sep 20, 2005
Start date
Apr 2005
Completion
Jan 2006
Last update
Oct 16, 2007
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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