Biologic Glue for First Degree Perineal Tears

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00746707

Enrollment

102

Registered

2008-09-04

Start date

2008-09-30

Completion date

2011-08-31

Last updated

2011-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grade 1 Perineal Tears

Keywords

adhesive glue, perineal tear, suture

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.

Interventions

DEVICE1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate

adhesive of perineal tears

PROCEDURE3. traditional suturing with vicryl rapid 2X0

suturing of perineal tears grade one with vicryl rapid 2X0

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Functional and cosmetic evaluation of perineal tear area.	At least six weeks after birth

Secondary

Measure	Time frame
Assessment of pain at least six weeks after delivery	At least six weeks after delivery

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026