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

Surgical Site Infection Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255927
• Other study ID #: PR2019-26
• Status: Completed
• Phase: Phase 4
• Start date: February 5, 2020
• Est. completion date: April 20, 2022

Study information

• Verified date: May 2022
• Source: ClinAmygate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 912
• Est. completion date: April 20, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Laparoscopic Surgery
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection

Intervention

Drug:
• Coated Vicryl plus
Vicryl plus (Coated Polyglactin 910 with Triclosan)
• Coated vicryl
Vicryl (Coated Polyglactin 910 without Triclosan)

Locations

Country	Name	City	State
Egypt	Misr Univeristy for Science and Technology Hospital	Giza

Sponsors (4)

Lead Sponsor	Collaborator
ClinAmygate	Al Safwa Hospital, Fayoum University Hospital, Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ahmed I, Boulton AJ, Rizvi S, Carlos W, Dickenson E, Smith NA, Reed M. The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019 Sep 3;9(9):e029727. doi: 10.1136/bmjope — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	port site infection (PSI)	the incidence of port site infection (PSI)	30 days
Secondary	hospital stay	Post-operative hospital stay in days	30 days