Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

University Hospital Center of São João

Status: Completed

Conditions: Mediolateral Episiotomy After Delivery

Treatments: Procedure: octyl-2-cyanoacrylate adhesive glue; Procedure: Subcuticular suture of perineal skin

Study type: Interventional

Funder types: Other

Identifiers

NCT00840788

Episio- 01 - RCT

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Skin adhesive

Experimental group

Description:

perineal skin repair with octyl-2-cyanoacrylate skin adhesive

Treatment:

Procedure: octyl-2-cyanoacrylate adhesive glue

subcuticular suture

Active Comparator group

Description:

continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910

Treatment:

Procedure: Subcuticular suture of perineal skin