Biologic Glue for First Degree Perineal Tears
Not Applicable
Completed
- Conditions
- Grade 1 Perineal Tears
- Interventions
- Device: 1. Dermabond Topical Skin Adhesive 2-Octyl CyanoacrylateProcedure: 3. traditional suturing with vicryl rapid 2X0
- 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.
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
- Arm && Interventions
Group Intervention Description 1 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate use of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women 3 3. traditional suturing with vicryl rapid 2X0 use of traditional suturing for perineal tear grade 1 in 50 women
- 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