Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

NCT ID: NCT00840788

Last Updated: 2009-02-10

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-01-31

Brief Summary

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Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.

Detailed Description

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Conditions

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Mediolateral Episiotomy After Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Skin adhesive

perineal skin repair with octyl-2-cyanoacrylate skin adhesive

Group Type EXPERIMENTAL

octyl-2-cyanoacrylate adhesive glue

Intervention Type PROCEDURE

use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy

subcuticular suture

continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910

Group Type ACTIVE_COMPARATOR

Subcuticular suture of perineal skin

Intervention Type PROCEDURE

Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair

Interventions

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octyl-2-cyanoacrylate adhesive glue

use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy

Intervention Type PROCEDURE

Subcuticular suture of perineal skin

Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair

Intervention Type PROCEDURE

Other Intervention Names

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Dermabond Vicryl

Eligibility Criteria

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Inclusion Criteria

* vaginal delivery
* episiotomy performed
* no further perineal or vaginal lesions present

Exclusion Criteria

* previously existing local infections or lesions
* body mass index \> 35 (Kg/m2)
* severe pulmonary disease
* collagen disease
* known immunodeficiency
* diabetes mellitus
* immunosuppressive treatment
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Porto

OTHER

Sponsor Role collaborator

Hospital Sao Joao

OTHER

Sponsor Role lead

Responsible Party

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Servico de Ginecologia e Obstetricia, Hospital de S. Joao

Principal Investigators

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Diogo Ayres-de-Campos, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto

Locations

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Servico de Ginecologia e Obstetricia, Hospital de S, Joao

Porto, Porto District, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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Episio- 01 - RCT

Identifier Type: -

Identifier Source: org_study_id

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