Steristrips Adhesive Tape Versus Subcuticular Suture for Episiotomy Repair in Primigravid Obese Women

Study Overview
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Brief Summary
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This study will be done to question the superiority of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women..

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 an increase in pain and dyspareunia during the puerperium This study will be commenced to question the advantage of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women.

Official Title
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Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial

Conditions
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Episiotomy Wound

Intervention / Treatment
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* Procedure: Adhesive tape
* Procedure: Continuous subcuticular skin suturing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primigravidae 18 years or older. Spontaneous not induced full term normal not instrumental vaginal delivery with mediolateral episiotomy. First and 2nd-degree perineal tear. BMI≥30 Exclusion Criteria: • patients who had an instrumental delivery. 3rd and fourth-degree perineal tears. those with local infectious lesions in the area to be repaired. preexisting medical disorders as diabetes mellitus, severe pulmonary disease and collagen disease. Immunosuppressive treatment. known hypersensitivity to adhesive tape or materials. Maternal unwillingness to undergo randomization.

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 |
| --- | --- |
| Experimental: Adhesive tape<br>will be subjected to skin repair after episiotomy with skin adhesive tape. | Procedure: Adhesive tape<br>* will be subjected to skin repair after episiotomy with skin adhesive tape.<br>|
| Active Comparator: Continuous subcuticular skin suturing<br>will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture. | Procedure: Continuous subcuticular skin suturing<br>* will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pain 6h postoperatively | the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. | 6 hours after the procedure | 
| Severity of pain 12 hours postpartum | the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity. VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. | 12 hours after 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 home visits for those may not be able to come back for the second visit. | 7-10 days after delivery | 
| Severity of pain 10 days postpartum | pain experience will be evaluated by visual analog scale | 10 days after procedure | 
| timing of procedure | timing of both procedures will be recorded and documented | During the procedure | 
| Severity of pain immediately after episiotomy repair | pain experience will be evaluated immediately after the procedure by the visual analog scale(VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. | immediately after the procedure |