Cesarean SectionNCT02288013
Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study
A study testing Closure of uterine incision at C section in people with Cesarean Section, run by Mohamed Zayed at 1 site in Egypt.
Trial summary
Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Closure of uterine incision at C section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Dec 2014
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All pregnant patients with an indication for delivery by C section
Who cannot join
- Patient refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Cairo University
Cairo, Cairo Governorate, 11559
About this study
Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.
Read the detailed description
A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.
- Conditions
- Cesarean Section
- Being tested
- Closure of uterine incision at C section
- Keywords
- Cesarean section, uterine closure technique, materials used
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of uterine incision at C sectionProcedure or surgery
Closure of uterine incision at Cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Stratafix Tissue control device | Other | Closure of Uterine incision at C section Receives: Procedure: Closure of uterine incision at C section |
| Vicryl suture | Other | Closure of uterine incision at C section Receives: Procedure: Closure of uterine incision at C section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed to close the uterine incision
A model is set to evaluate success and failure according the ime needed to close the uterine incision if more or less than 6 minutes
Measured: 6 minutes
Secondary outcomes (1)
blood loss during uterine closure
Measured: intraoperative during uterine closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Zayed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Johnson & Johnson Medical Companies
- Responsible party
- Sponsor-investigator, Mohamed Zayed, Cairo University
- Investigators
- Mohamed Z Ahmed, MD PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288013
- Sponsor's protocol ID
- IIS 13-207
- Status last verified
- Jan 2016
- First submitted
- 5 Nov 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study
- ClinicalTrials.gov ID
- NCT02288013
- Acronym / sponsor ID
- IIS 13-207
- Conditions
- Cesarean Section
- Keywords
- Cesarean section, uterine closure technique, materials used
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mohamed ZayedUniversity, hospital or other
- Collaborators
- Cairo University, Johnson & Johnson Medical Companies
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Nov 2014 (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.
Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.
Detailed description
A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratafix Tissue control device | Other | Procedure: Closure of uterine incision at C sectionClosure of Uterine incision at C section |
| Vicryl suture | Other | Procedure: Closure of uterine incision at C sectionClosure of uterine incision at C section |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant patients with an indication for delivery by C section
Key exclusion criteria (1 listed)
- Patient refusing to participate in the study
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 |
|---|---|---|
| Closure of uterine incision at C sectionClosure of uterine incision at Cesarean section | Procedure or surgery | Stratafix Tissue control device, Vicryl suture |
Primary outcome
Time needed to close the uterine incision
Time frame: 6 minutes
A model is set to evaluate success and failure according the ime needed to close the uterine incision if more or less than 6 minutes
1 secondary outcome
blood loss during uterine closure
Time frame: intraoperative during uterine closure
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 27 Jan 2016.
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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.
Mohamed Z Ahmed, MD PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of uterine incision at C section in people with Cesarean Section, run by Mohamed Zayed at 1 site in Egypt.
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 1 inclusion and 1 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Time needed to close the uterine incision (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2016.