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Evaluation of Triclosan Coated Suture in Obstetrical Surgery

Evaluation of Triclosan Coated Suture in Obstetrical Surgery: A Randomized Controlled Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05330650
Enrollment
318
Registered
2022-04-15
Start date
2020-11-01
Completion date
2021-06-30
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section; Infection

Keywords

Surgical Site Infections, caesarean section, healthcare costs

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.

Interventions

DRUGCoated Vicryl+

We used coated suture for : hystetrotomy reparation / aponeurosis and skin closure.

DRUGVicryl

We used non coated suture for : hystetrotomy reparation / aponeurosis and skin closure.

Sponsors

Tunis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women with indicated cesarean delivery and who have signed a written consent.

Exclusion criteria

* Cases with incomplete follow up * Breach of operative protocol

Design outcomes

Primary

MeasureTime frame
Incidence of surgical site infection30 days

Secondary

MeasureTime frameDescription
Health care costs attributable to surgical site infection30 daysEvaluation of health care costs from Hospital perspective (USD)
Wound healing time30 daysEvaluation of healing time (days)

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026