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Completed

NCT Number: NCT02608671

Adhesive Tape in Episiotomy Repair

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin adhesive tape

Procedure

Other names: (® Steri-Strip

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Dr. Ahmed Sherif
  • Dr. Mohamed Mahmoud El Sherbiny
  • Dr.Haitham Torky
  • Lobna Ahmed Nabil
  • Prof. Mohamed Ashraf Mohamed Farouk Kortam

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2015
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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