Episiotomy Clinical Trial
Official title:
SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL
Verified date | January 2021 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
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 |
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
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 |
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 |