Biologic Glue for First Degree Perineal Tears

NCT ID: NCT00746707

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Grade 1 Perineal Tears

Keywords

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adhesive glue, perineal tear, suture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate

Intervention Type DEVICE

adhesive of perineal tears

3

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

Group Type ACTIVE_COMPARATOR

3. traditional suturing with vicryl rapid 2X0

Intervention Type PROCEDURE

suturing of perineal tears grade one with vicryl rapid 2X0

Interventions

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1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate

adhesive of perineal tears

Intervention Type DEVICE

3. traditional suturing with vicryl rapid 2X0

suturing of perineal tears grade one with vicryl rapid 2X0

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Ezra Yosi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yosef ezra, M.D.

Role: STUDY_DIRECTOR

hadassha medical organization, jerusalem israel

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26.

Reference Type DERIVED
PMID: 25089271 (View on PubMed)

Other Identifiers

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feigenberg HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id