Biologic Glue for First Degree Perineal Tears

Hadassah Medical Center

Status: Completed

Conditions: Grade 1 Perineal Tears

Treatments: Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate; Procedure: 3. traditional suturing with vicryl rapid 2X0

Study type: Interventional

Funder types: Other

Identifiers

NCT00746707

feigenberg HMO-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

1

Experimental group

Description:

use of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women

Treatment:

Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate

3

Active Comparator group

Description:

use of traditional suturing for perineal tear grade 1 in 50 women

Treatment:

Procedure: 3. traditional suturing with vicryl rapid 2X0