Biologic Glue for First Degree Perineal Tears

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ezra Yosi, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00746707
First received: September 3, 2008
Last updated: December 17, 2011
Last verified: December 2011
  Purpose

The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair


Condition Intervention
Grade 1 Perineal Tears
Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate
Procedure: 3. traditional suturing with vicryl rapid 2X0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Functional and cosmetic evaluation of perineal tear area. [ Time Frame: At least six weeks after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of pain at least six weeks after delivery [ Time Frame: At least six weeks after delivery ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
use of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women
Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate
adhesive of perineal tears
Active Comparator: 3
use of traditional suturing for perineal tear grade 1 in 50 women
Procedure: 3. traditional suturing with vicryl rapid 2X0
suturing of perineal tears grade one with vicryl rapid 2X0

Detailed Description:

This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears

Exclusion Criteria:

  • excessive bleeding,
  • chronic steroid treatment,
  • immunosuppressive treatment,
  • active infection,
  • allergy to Dermabond or Histoacryl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746707

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: yosef ezra, M.D. hadassha medical organization, jerusalem israel
  More Information

No publications provided

Responsible Party: Ezra Yosi, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00746707     History of Changes
Other Study ID Numbers: feigenberg HMO-CTIL
Study First Received: September 3, 2008
Last Updated: December 17, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
adhesive glue, perineal tear, suture

Additional relevant MeSH terms:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014