Evaluation of Triclosan Coated Suture in Obstetrical Surgery
1 other identifier
interventional
318
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedApril 15, 2022
April 1, 2022
7 months
March 21, 2022
April 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of surgical site infection
30 days
Secondary Outcomes (2)
Health care costs attributable to surgical site infection
30 days
Wound healing time
30 days
Study Arms (2)
Triclosan coated suture
ACTIVE COMPARATORNon coated suture
ACTIVE COMPARATORInterventions
We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.
We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.
Eligibility Criteria
You may qualify if:
- Pregnant women with indicated cesarean delivery and who have signed a written consent.
You may not qualify if:
- Cases with incomplete follow up
- Breach of operative protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tunis Universitylead
Study Sites (1)
Obstetrics and Gynecology Departement
Ben Arous, 2096, Tunisia
Related Publications (1)
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.
PMID: 36520813DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chaouki Mbarki
Ben Arous Hospital, Tunis, Tunisia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 21, 2022
First Posted
April 15, 2022
Study Start
November 1, 2020
Primary Completion
May 31, 2021
Study Completion
June 30, 2021
Last Updated
April 15, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share