Biologic Glue for First Degree Perineal Tears

Grade 1 Perineal Tears Clinical Trial

Official title:

Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746707
• Other study ID #: feigenberg HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: December 17, 2011
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grade 1 Perineal Tears

Intervention

Device:
• 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate
adhesive of perineal tears

Procedure:
• 3. traditional suturing with vicryl rapid 2X0
suturing of perineal tears grade one with vicryl rapid 2X0

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional and cosmetic evaluation of perineal tear area.		At least six weeks after birth	No
Secondary	Assessment of pain at least six weeks after delivery		At least six weeks after delivery	No