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Adhesive Tape in Episiotomy Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608671
Recruitment Status : Unknown
Verified January 2017 by Ahmed Abass, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
Lobna Ahmed Nabil
Dr. Ahmed Sherif
Dr. Mohamed Mahmoud El Sherbiny
Prof. Mohamed Ashraf Mohamed Farouk Kortam
Dr.Haitham Torky
Information provided by (Responsible Party):
Ahmed Abass, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Episiotomy Procedure: Skin adhesive tape Phase 4

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL
Study Start Date : December 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
No Intervention: Continuous skin suturing
will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.
Experimental: Adhesive tape
will be subjected to skin repair after episiotomy with skin adhesive tape.
Procedure: Skin adhesive tape
Other Name: (® Steri-Strip




Primary Outcome Measures :
  1. postoperative pain [ Time Frame: During the procedure ]

    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.



Secondary Outcome Measures :
  1. wound healing. [ Time Frame: 10 days ]
    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.

  2. wound sepsis [ Time Frame: 10 days ]
    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.

  3. Postoperative pain [ Time Frame: 2 hours after procedure ]
    pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale .

  4. Postoperative pain [ Time Frame: 6 hours after procedure ]
    pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale .

  5. Postoperative pain [ Time Frame: 12 hours after procedure ]
    pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale .

  6. Postoperative pain [ Time Frame: 10 days after procedure ]
    pain experience will be evaluated by Wong-Baker faces pain rating scale .

  7. timing of procedure [ Time Frame: During the procedure ]
    timing of both procedures will be recorded and documented



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications of Results:
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Responsible Party: Ahmed Abass, lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT02608671    
Other Study ID Numbers: Adhesive tape&episiotomy
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Keywords provided by Ahmed Abass, Ain Shams University:
Episiotomy
continuous suture
Skin adhesive tape