EpisiotomyPhase 4NCT02608671
Adhesive Tape in Episiotomy Repair
A Phase 4 study testing Skin adhesive tape in people with Episiotomy, run by Ain Shams University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy
- What is being tested?
- Skin adhesive tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 1 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primiparous.
- First and second degree perineal tear.
- Normal not instrumental vaginal delivery; spontaneous not induced.
- Patient willingness to randomize to episiotomy repair technique.
Who cannot join
- 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.
About this study
Official title: SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL
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.
Read the 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.
- Conditions
- Episiotomy
- Being tested
- Skin adhesive tape
- Keywords
- Episiotomy, continuous suture, Skin adhesive tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin adhesive tapeProcedure or surgery
Also called (® Steri-Strip
| Study group | Role | What they receive |
|---|---|---|
| Continuous skin suturing | No intervention | will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture. |
| Adhesive tape | Experimental | will be subjected to skin repair after episiotomy with skin adhesive tape. Receives: Procedure: Skin adhesive tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure
Secondary outcomes (7)
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.
Measured: 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.
Measured: 10 days
Postoperative pain
pain experience will be evaluated 2 hours after the procedure by Wong-Baker faces pain rating scale .
Measured: 2 hours after procedure
Postoperative pain
pain experience will be evaluated 6 hours after the procedure by Wong-Baker faces pain rating scale .
Measured: 6 hours after procedure
Postoperative pain
pain experience will be evaluated 12 hours after the procedure by Wong-Baker faces pain rating scale .
Measured: 12 hours after procedure
Postoperative pain
pain experience will be evaluated by Wong-Baker faces pain rating scale .
Measured: 10 days after procedure
timing of procedure
timing of both procedures will be recorded and documented
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion1 Jan 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Lobna Ahmed Nabil, Dr. Ahmed Sherif, Dr. Mohamed Mahmoud El Sherbiny, Prof. Mohamed Ashraf Mohamed Farouk Kortam, Dr.Haitham Torky
- Responsible party
- Principal investigator, Ahmed Abass, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608671
- Sponsor's protocol ID
- Adhesive tape&episiotomy
- Status last verified
- Jan 2021
- First submitted
- 9 Nov 2015
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25089271Ghosh 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: 10.4103/0976-237X.152938.
PubMed 25821376
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SKIN ADHESIVE TAPE COMPARED WITH CONTINUOUS SUTURE IN PERINEAL SKIN REPAIR AFTER EPISIOTOMY: RANDOMIZED TRIAL
- ClinicalTrials.gov ID
- NCT02608671
- Acronym / sponsor ID
- Adhesive tape&episiotomy
- Conditions
- Episiotomy
- Keywords
- Episiotomy, continuous suture, Skin adhesive tape
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Lobna Ahmed Nabil, Dr. Ahmed Sherif, Dr. Mohamed Mahmoud El Sherbiny, Prof. Mohamed Ashraf Mohamed Farouk Kortam, Dr.Haitham Torky
- Study start
- Dec 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous skin suturing | No intervention | –will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture. |
| Adhesive tape | Experimental | Procedure: Skin adhesive tapewill be subjected to skin repair after episiotomy with skin adhesive tape. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primiparous.
- First and second degree perineal tear.
- Normal not instrumental vaginal delivery; spontaneous not induced.
- Patient willingness to randomize to episiotomy repair technique.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin adhesive tapeAlso: (® Steri-Strip | Procedure or surgery | Adhesive tape |
Primary outcome
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.
7 secondary outcomes
wound healing.
Time frame: 10 days
wound sepsis
Time frame: 10 days
Postoperative pain
Time frame: 2 hours after procedure
Postoperative pain
Time frame: 6 hours after procedure
Postoperative pain
Time frame: 12 hours after procedure
Postoperative pain
Time frame: 10 days after procedure
timing of procedure
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Results publication: PubMed 25089271Feigenberg 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.
- Results publication: PubMed 25821376Ghosh 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: 10.4103/0976-237X.152938.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin adhesive tape in people with Episiotomy, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02608671, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.