Suture, ComplicationNCT04455321
The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study
A study testing Suture materials effect on istmocel in people with Suture, Complication and Istmocel, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of suture materials with different absorption times on istmocel. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Suture, Complication, Istmocel
- What is being tested?
- Suture materials effect on istmocel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 Jan 2021
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primary cesarean section
- single pregnancy
- 18-45 age
Who cannot join
- Diabetes mellitus disease
- inflammatory bowel disease
- systemic lupus erythematosus disease
- rheumatoid arthritis disease
- previous uterine surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Adana Dr. Turgut Noyan Hospital
Adana, 01000
About this study
This study aims to investigate the effect of suture materials with different absorption times on istmocel.
- Conditions
- Suture, Complication, Istmocel
- Being tested
- Suture materials effect on istmocel
- Keywords
- rapid, suture material, istmocel
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture materials effect on istmocelProcedure or surgery
Effect of suture materials with different absorption times on istmocel
| Study group | Role | What they receive |
|---|---|---|
| Vicryl | Active comparator | Single layer locked uterine closure with vicryl suture material Receives: Procedure: Suture materials effect on istmocel |
| rapide vicryl | Experimental | Single layer locked uterine closure with rapide vicryl suture material Receives: Procedure: Suture materials effect on istmocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Istmocel
Istmocel area measurement with saline-infusion ultrasonography
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start15 Mar 2020
- Primary completion1 Aug 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture, ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selçuk Yetkinel, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455321
- Sponsor's protocol ID
- KA19/170
- Status last verified
- Feb 2021
- First submitted
- 29 Jun 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04455321
- Acronym / sponsor ID
- KA19/170
- Conditions
- Suture, Complication, Istmocel
- Keywords
- rapid, suture material, istmocel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 2 Jul 2020 (actual)
- 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 aims to investigate the effect of suture materials with different absorption times on istmocel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
| Arm | Type | Receives |
|---|---|---|
| Vicryl | Active comparator | Procedure: Suture materials effect on istmocelSingle layer locked uterine closure with vicryl suture material |
| rapide vicryl | Experimental | Procedure: Suture materials effect on istmocelSingle layer locked uterine closure with rapide vicryl suture material |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- primary cesarean section
- single pregnancy
- 18-45 age
Key exclusion criteria (5 listed)
- Diabetes mellitus disease
- inflammatory bowel disease
- systemic lupus erythematosus disease
- rheumatoid arthritis disease
- previous uterine surgery
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 |
|---|---|---|
| Suture materials effect on istmocelEffect of suture materials with different absorption times on istmocel | Procedure or surgery | Vicryl, rapide vicryl |
Primary outcome
Istmocel
Time frame: Six months
Istmocel area measurement with saline-infusion ultrasonography
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 9 Feb 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture materials effect on istmocel in people with Suture, Complication and Istmocel, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 9 Feb 2021. 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 Turkey (Türkiye). 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?
Istmocel (time frame: Six months). 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 9 Feb 2021.