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

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00196508
First received: September 13, 2005
Last updated: October 13, 2007
Last verified: June 2006

September 13, 2005
October 13, 2007
April 2005
Not Provided
  • 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
  • High Viscosity DERMABOND 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 up to 6 weeks post-partum.
Complete list of historical versions of study NCT00196508 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Not Provided
Not Provided
 
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Episiotomy
  • Perineal Tear
Device: High Viscosity DERMABOND
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
January 2006
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00196508
200-04-001
Not Provided
Not Provided
Ethicon, Inc.
Not Provided
Not Provided
Ethicon, Inc.
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP