Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02608671
Other study ID # Adhesive tape&episiotomy
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2015
Est. completion date December 1, 2017

Study information

Verified date January 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date December 1, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Skin adhesive tape


Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
Ain Shams University Dr. Ahmed Sherif, Dr. Mohamed Mahmoud El Sherbiny, Dr.Haitham Torky, Lobna Ahmed Nabil, Prof. Mohamed Ashraf Mohamed Farouk Kortam

References & Publications (2)

Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26. — View Citation

Ghosh A, Nanjappa M, Nagaraj V, Rajkumar GC. Comparison between stainless steel staples and silk sutures for primary closure of skin in patients undergoing neck dissection: A comparative clinical study. Contemp Clin Dent. 2015 Mar;6(Suppl 1):S51-5. doi: 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Postoperative pain pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale . 2 hours after procedure
Secondary Postoperative pain pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale . 6 hours after procedure
Secondary Postoperative pain pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale . 12 hours after procedure
Secondary Postoperative pain pain experience will be evaluated by Wong-Baker faces pain rating scale . 10 days after procedure
Secondary timing of procedure timing of both procedures will be recorded and documented During the procedure
See also
  Status Clinical Trial Phase
Completed NCT02762357 - PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
Completed NCT00070720 - Improving Perinatal Care in Latin America Phase 4
Completed NCT03084549 - Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain Phase 3
Not yet recruiting NCT06415877 - The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training N/A
Recruiting NCT05345600 - MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery N/A
Active, not recruiting NCT02615236 - Prospective Evaluation of Perineal Ultrasound in Thr Delivery Room to Improve the Diagnosis of OASIS N/A
Recruiting NCT02847936 - Efficacy of Triclosan-coated Sutures in the Episiotomy Phase 4
Withdrawn NCT02796547 - Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery Phase 2
Completed NCT02905695 - Post-partum Perineal Pain - Chirocaine® Phase 4
Not yet recruiting NCT05905263 - The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels N/A
Not yet recruiting NCT03780530 - Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair Phase 3
Completed NCT02911779 - The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor N/A
Completed NCT05776849 - Flipped Classroom in Episiotomy Education N/A
Completed NCT00265421 - Study of Different Suturing Techniques for Perineal Repair After Delivery N/A
Completed NCT05486624 - The Effect of Reiki Application on Episiotomy and Perineal Pain N/A
Completed NCT00196508 - A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth Phase 3