Biologic Glue for First Degree Perineal Tears

Not Applicable

Completed

• Conditions: Grade 1 Perineal Tears

• Registration Number: NCT00746707
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-17
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional and cosmetic evaluation of perineal tear area.	At least six weeks after birth

Secondary Outcome Measures

Name	Time	Method
Assessment of pain at least six weeks after delivery	At least six weeks after delivery

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel