Adhesive Tape in Episiotomy Repair

Ain Shams University320 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

320

Conditions

Episiotomy

Interventions

Skin adhesive tapePROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

postoperative pain

pain experience will be evaluated during the procedure,, 6 hours and 12 hours after the procedure by Wong-Baker faces pain rating scale . During the second visit 7-10 days after delivery; pain and patient satisfaction will be evaluated and recorded, data may be collected by phone for those may not be able to come back for the second visit.

Time frame: During the procedure

Secondary Outcomes

wound healing.

During the second visit 7-10 days after delivery; wound healing will be evaluated and recorded by Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA), data may be collected by phone for those may not be able to come back for the second visit.

Time frame: 10 days

wound sepsis

During the second visit 7-10 days after delivery; wound sepsis will be evaluated and recorded by wound sepsis score, data may be collected by phone for those may not be able to come back for the second visit.

Time frame: 10 days

Postoperative pain

pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale .

Time frame: 2 hours after procedure

Postoperative pain

pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale .

Time frame: 6 hours after procedure

Postoperative pain

pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale .

Time frame: 12 hours after procedure

Postoperative pain

Data from ClinicalTrials.gov

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