Cesarean Section; InfectionPhase 4NCT05330650
Evaluation of Triclosan Coated Suture in Obstetrical Surgery
A Phase 4 study testing Coated Vicryl+ and Vicryl in people with Cesarean Section; Infection, run by Tunis University at 1 site in Tunisia.
Trial summary
A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021. The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery. 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
- Cesarean Section; Infection
- What is being tested?
- Coated Vicryl+ and Vicryl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2020to 30 Jun 2021
- 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
- Pregnant women with indicated cesarean delivery and who have signed a written consent.
Who cannot join
- Cases with incomplete follow up
- Breach of operative protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study
A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021.
The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.
- Conditions
- Cesarean Section; Infection
- Being tested
- Coated Vicryl+, Vicryl
- Keywords
- Surgical Site Infections, caesarean section, healthcare costs
- Medical subject headings
- Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated Vicryl+Drug
We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.
VicrylDrug
We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Triclosan coated suture | Active comparator | Not described Receives: Drug: Coated Vicryl+ |
| Non coated suture | Active comparator | Not described Receives: Drug: Vicryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
Measured: 30 days
Secondary outcomes (2)
Health care costs attributable to surgical site infection
Evaluation of health care costs from Hospital perspective (USD)
Measured: 30 days
Wound healing time
Evaluation of healing time (days)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Nov 2020
- Primary completion31 May 2021
- Study completion30 Jun 2021
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 Section; InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajer BETTAIEB, Tunis University
- Investigators
- Chaouki Mbarki, Study director, Ben Arous Hospital, Tunis, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330650
- Sponsor's protocol ID
- TunisU 1
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mbarki W, Bettaieb H, Souayeh N, Laabidi I, Rouis H, Halouani S, Boufarghine R, Bouyahia M, Bouhmida R, Ouederni M, Ben Amor A, Chermiti A, Laamiri H, Lika A, Chaibi I, Oueslati H, Hsayaoui N, Mbarki C. Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650). PLoS One. 2022 Dec 15;17(12):e0278939. doi: 10.1371/journal.pone.0278939. eCollection 2022.
PubMed 36520813
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05330650
- Acronym / sponsor ID
- TunisU 1
- Conditions
- Cesarean Section; Infection
- Keywords
- Surgical Site Infections, caesarean section, healthcare costs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Apr 2022 (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.
A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021.
The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triclosan coated suture | Active comparator | Drug: Coated Vicryl+ |
| Non coated suture | Active comparator | Drug: Vicryl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women with indicated cesarean delivery and who have signed a written consent.
Key exclusion criteria (2 listed)
- Cases with incomplete follow up
- Breach of operative protocol
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 |
|---|---|---|
| Coated Vicryl+We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure. | Drug | Triclosan coated suture |
| VicrylWe used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure. | Drug | Non coated suture |
Primary outcome
Incidence of surgical site infection
Time frame: 30 days
2 secondary outcomes
Health care costs attributable to surgical site infection
Time frame: 30 days
Wound healing time
Time frame: 30 days
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 15 Apr 2022.
- Derived from this study: PubMed 36520813Mbarki W, Bettaieb H, Souayeh N, Laabidi I, Rouis H, Halouani S, Boufarghine R, Bouyahia M, Bouhmida R, Ouederni M, Ben Amor A, Chermiti A, Laamiri H, Lika A, Chaibi I, Oueslati H, Hsayaoui N, Mbarki C. Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650). PLoS One. 2022 Dec 15;17(12):e0278939. doi: 10.1371/journal.pone.0278939. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section; Infection
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Restoration of the Gut Microbiome After Cesarean Section
Microbial Colonization
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Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
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Surgical Site Infection (SSI)
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Intraperitoneal Saline Irrigation in Cesarean Section
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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.
Chaouki Mbarki study director
Ben Arous Hospital, Tunis, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coated Vicryl+ and Vicryl in people with Cesarean Section; Infection, run by Tunis University at 1 site in Tunisia.
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 2 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 15 Apr 2022. 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 Tunisia. 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 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?
Incidence of surgical site infection (time frame: 30 days). 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 NCT05330650, 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 15 Apr 2022.