Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

Not Applicable

Completed

• Conditions: Mediolateral Episiotomy After Delivery
• Interventions: Procedure: octyl-2-cyanoacrylate adhesive glue; Procedure: Subcuticular suture of perineal skin

• Registration Number: NCT00840788
• Lead Sponsor: Hospital Sao Joao

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-05
• Study Completion: 2007-01
• Status Verified: 2009-02
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Last Update Submitted: 2009-02-09
• Study First Posted: 2009-02-10
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin adhesive	octyl-2-cyanoacrylate adhesive glue	perineal skin repair with octyl-2-cyanoacrylate skin adhesive
subcuticular suture	Subcuticular suture of perineal skin	continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910

Primary Outcome Measures

Name	Time	Method
Self-assessed perineal pain	First 30 days after delivery

Secondary Outcome Measures

Name	Time	Method
Total time spent with repair of episiotomy	within 1 hour after birth
Pain during procedure	within 1 hour after birth
Difficulties reported during procedure	within 1 hour after birth
Number of sutures and adhesive devices used	within 1 hour after birth
Wound complications	42-68 hours after delivery
Need to seek health facilities	30 days after delivery
Return of sexual activity	30 days after delivery

Trial Locations

Locations (1)

Servico de Ginecologia e Obstetricia, Hospital de S, Joao; 🇵🇹 Porto, Portugal