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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Hadassah Medical Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

ClinicalTrials.gov processed this record on September 16, 2014