A Phase 4 interventional study of Skin adhesive tape in Episiotomy, sponsored by Ain Shams University. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
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.
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.
will be subjected to skin repair after episiotomy with skin adhesive tape.
Procedure: Skin adhesive tape
Also known as: (® Steri-Strip
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.
Time frame: During the procedure
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.
Time frame: 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.
Time frame: 10 days
Postoperative pain
pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale .
Time frame: 2 hours after procedure
Postoperative pain
pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale .
Time frame: 6 hours after procedure
Postoperative pain
pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale .
Time frame: 12 hours after procedure
Postoperative pain
pain experience will be evaluated by Wong-Baker faces pain rating scale .
Time frame: 10 days after procedure
timing of procedure
timing of both procedures will be recorded and documented
Time frame: During the procedure
No study locations are listed for this record.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Ain Shams University