Biologic Glue for First Degree Perineal Tears

Hadassah Medical Organization102 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

102

Conditions

Grade 1 Perineal Tears

Interventions

1. Dermabond Topical Skin Adhesive 2-Octyl CyanoacrylateDEVICE

adhesive of perineal tears

3. traditional suturing with vicryl rapid 2X0PROCEDURE

suturing of perineal tears grade one with vicryl rapid 2X0

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

Functional and cosmetic evaluation of perineal tear area.

Time frame: At least six weeks after birth

Secondary Outcomes

Assessment of pain at least six weeks after delivery

Time frame: At least six weeks after delivery

Data from ClinicalTrials.gov

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