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Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.

Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255927
Enrollment
912
Registered
2020-02-05
Start date
2020-02-05
Completion date
2022-04-20
Last updated
2022-05-11

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

Conditions

Laparoscopic Surgery, Surgical Site Infection, Surgical Wound

Brief summary

Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Detailed description

In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Interventions

Vicryl plus (Coated Polyglactin 910 with Triclosan)

DRUGCoated vicryl

Vicryl (Coated Polyglactin 910 without Triclosan)

Sponsors

Misr University for Science and Technology
CollaboratorOTHER
Al Safwa Hospital
CollaboratorUNKNOWN
Fayoum University Hospital
CollaboratorOTHER
ClinAmygate
Lead SponsorOTHER

Study design

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

Intervention model description

randomized-controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* age 18-75 * candidate for laparoscopic surgical intervention during the period of the study were included.

Exclusion criteria

* Patient has immunodeficiency disorder. * Patient receiving anti-cancer / immunosuppressive therapy. * Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.

Design outcomes

Primary

MeasureTime frameDescription
port site infection (PSI)30 daysthe incidence of port site infection (PSI)

Secondary

MeasureTime frameDescription
hospital stay30 daysPost-operative hospital stay in days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026