Adhesive Tape in Episiotomy Repair

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

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Episiotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Continuous skin suturing

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Adhesive tape

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

Group Type EXPERIMENTAL

Skin adhesive tape

Intervention Type PROCEDURE

Interventions

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Skin adhesive tape

Intervention Type PROCEDURE

Other Intervention Names

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(® Steri-Strip

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes