Adhesive Tape in Episiotomy Repair

Study Overview
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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.

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.

Official Title
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SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL

Conditions
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Episiotomy

Intervention / Treatment
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* Procedure: Skin adhesive tape


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Continuous skin suturing<br>will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture. | |
| Experimental: Adhesive tape<br>will be subjected to skin repair after episiotomy with skin adhesive tape. | Procedure: Skin adhesive tape<br> <br> * Other names: (® Steri-Strip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 10 days | 
| Postoperative pain | pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale . | 2 hours after procedure | 
| Postoperative pain | pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale . | 6 hours after procedure | 
| Postoperative pain | pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale . | 12 hours after procedure | 
| Postoperative pain | pain experience will be evaluated by Wong-Baker faces pain rating scale . | 10 days after procedure | 
| timing of procedure | timing of both procedures will be recorded and documented | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Episiotomy, continuous suture, Skin adhesive tape