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

Phase 4

Completed

• Conditions: Laparoscopic Surgery; Surgical Site Infection; Surgical Wound
• Interventions: Drug: Coated Vicryl plus; Drug: Coated vicryl

• Registration Number: NCT04255927
• Lead Sponsor: ClinAmygate

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.

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-04
• Study Start: 2020-02-05
• Study First Posted: 2020-02-05
• Primary Completion: 2022-03-10
• Study Completion: 2022-04-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 912

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coated Polyglactin 910 with Triclosan	Coated Vicryl plus	Coated Polyglactin 910 with Triclosan
Coated Polyglactin 910 without Triclosan	Coated vicryl	Coated Polyglactin 910 without Triclosan

Primary Outcome Measures

Name	Time	Method
port site infection (PSI)	30 days	the incidence of port site infection (PSI)

Secondary Outcome Measures

Name	Time	Method
hospital stay	30 days	Post-operative hospital stay in days

Trial Locations

Locations (1)

Misr Univeristy for Science and Technology Hospital; 🇪🇬 Giza, Egypt