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

NCT00196508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2007-10-16

No results posted yet for this 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.

Conditions

  • Episiotomy
  • Perineal Tear

Interventions

DEVICE

High Viscosity DERMABOND

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2006-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00196508 on ClinicalTrials.gov