Adhesive Tape in Episiotomy Repair

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Episiotomy

Treatments: Procedure: Skin adhesive tape

Study type: Interventional

Funder types: Other

Identifiers

NCT02608671

Adhesive tape&episiotomy

Details and patient eligibility

About

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

Full description

Episiotomy is the most common operating procedure that most obstetricians will perform in their lifetime. Because it is so common and considered minor surgery, teaching students or interns the principles and techniques usually is left to the most junior of residents

The optimal method for episiotomy and perineal trauma repair following childbirth remains open to debate and a great cause of concern to doctors, midwives, and the public

Apparently, the ideal method for perineal repair should be quick, painless, easy to perform and preferably, without increase in pain and dyspareunia during the puerperium

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primiparous.
• First and second degree perineal tear.
• Normal not instrumental vaginal delivery; spontaneous not induced.
• Patient willingness to randomize to episiotomy repair technique.

Exclusion criteria

• Previously existing local infections or lesions.
• Third and forth degrees perineal tear.
• Maternal diseases interfere with wound healing or causing excessive bleeding (coagulopathy, collagen disease, diabetes mellitus, known immunodeficiency, immunosuppressive treatment).
• Known hypersensitivity to adhesive materials
• Maternal unwillingness to undergo randomization.
• Participation in another intervention-trial with interference of intervention and/or outcome of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups

Continuous skin suturing

No Intervention group

Description:

will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.

Adhesive tape

Experimental group

Description:

will be subjected to skin repair after episiotomy with skin adhesive tape.

Treatment:

Procedure: Skin adhesive tape