Cesarean SectionPhase 3barbedNCT02962011
Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
A Phase 3 study testing Knotless barbed suture and polyglactin 910 in people with Cesarean Section, run by Ziv Hospital at 1 site in Israel.
Trial summary
This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Knotless barbed suture and polyglactin 910
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2016to Aug 2017
- Phase
- Phase 3
- 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
- elective cesarean
- elective repeat cesarean
Who cannot join
- emergent or urgent cesarean
- PROM
- chorioamninitis
- placental abruption
- placenta previa or accreta
- known uterine fibroids
- women with known medical problems such as coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
This was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained
- Conditions
- Cesarean Section
- Being tested
- Knotless barbed suture, polyglactin 910
- Keywords
- Cesarean, incision, suture,
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knotless barbed sutureDevice
Also called Stratafix
uterine incision closure
polyglactin 910Device
Also called Vicryl
uterine incision closure
| Study group | Role | What they receive |
|---|---|---|
| Knotless barbed suture | Experimental | Not described Receives: Device: Knotless barbed suture |
| polyglactin 910 | Active comparator | Vicryl Receives: Device: polyglactin 910 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine incision closure time
uterine incision closure time
Measured: 5 months
Secondary outcomes (2)
uterine incision blood loss
uterine incision blood loss
Measured: 5 months
hemostatic suture use
hemostatic suture use
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Mar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Knotless barbed suture vs conventional suture of uterine incision
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Peleg, Ziv Hospital
- Investigators
- David Peleg, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962011
- Sponsor's protocol ID
- ZIVH
- Acronym
- barbed
- Status last verified
- Jun 2018
- First submitted
- 9 Nov 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Peleg D, Ahmad RS, Warsof SL, Marcus-Braun N, Sciaky-Tamir Y, Ben Shachar I. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at cesarean delivery. Am J Obstet Gynecol. 2018 Mar;218(3):343.e1-343.e7. doi: 10.1016/j.ajog.2018.01.043. Epub 2018 Feb 5.
PubMed 29496259
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Barbed and Non-barbed Suture for Uterine Incision Closure at Cesarean Section
- ClinicalTrials.gov ID
- NCT02962011
- Acronym / sponsor ID
- barbed / ZIVH
- Conditions
- Cesarean Section
- Keywords
- Cesarean, incision, suture,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Nov 2016 (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 was an unblinded randomized controlled trial. Women were randomized to uterine closure with the knotless barbed suture (Stratafix PDS, Ethicon) or Vicryl (Ethicon) at the time of elective cesarean. The primary outcome was closure time of the uterine incision. Also measured were blood loss during incision closure and the use of additional hemostatic sutures. Informed consent was obtained
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Knotless barbed suture vs conventional suture of uterine incision
| Arm | Type | Receives |
|---|---|---|
| Knotless barbed suture | Experimental | Device: Knotless barbed suture |
| polyglactin 910 | Active comparator | Device: polyglactin 910Vicryl |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- elective cesarean
- elective repeat cesarean
Key exclusion criteria (7 listed)
- emergent or urgent cesarean
- PROM
- chorioamninitis
- placental abruption
- placenta previa or accreta
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 |
|---|---|---|
| Knotless barbed sutureAlso: Stratafixuterine incision closure | Device | Knotless barbed suture |
| polyglactin 910Also: Vicryluterine incision closure | Device | polyglactin 910 |
Primary outcome
Uterine incision closure time
Time frame: 5 months
uterine incision closure time
2 secondary outcomes
uterine incision blood loss
Time frame: 5 months
hemostatic suture use
Time frame: 5 months
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 Jun 2018.
- Derived from this study: PubMed 29496259Peleg D, Ahmad RS, Warsof SL, Marcus-Braun N, Sciaky-Tamir Y, Ben Shachar I. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at cesarean delivery. Am J Obstet Gynecol. 2018 Mar;218(3):343.e1-343.e7. doi: 10.1016/j.ajog.2018.01.043. Epub 2018 Feb 5.
- Individual participant dataSharing planned: Undecided
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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.
David Peleg principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Knotless barbed suture and polyglactin 910 in people with Cesarean Section, run by Ziv Hospital at 1 site in Israel.
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 2 inclusion and 7 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 Jun 2018. 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 Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Uterine incision closure time (time frame: 5 months). 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 NCT02962011, which also lists 1 linked publication.
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 Jun 2018.