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NCT04256824 Clinical Trial

Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds

Surgical Site Infection Clinical Trial

Official title:
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04256824
Other study ID # PR2019-27
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 5, 2020
Est. completion date January 30, 2024

Study information
Verified date September 2023
Source ClinAmygate
Contact Emad R Issak, Diploma
Phone 00201272228989
Email dr.emad.r.h.issak@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery

Description:

Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.

Recruitment information / eligibility
Status Recruiting
Enrollment 430
Est. completion date January 30, 2024
Est. primary completion date October 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - age: 18-75 - clean-contaminated wound surgery 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

Related Conditions & MeSH terms

Intervention

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

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

Sponsors (6)
Lead Sponsor Collaborator
ClinAmygate Al Safwa Hospital, Al Zohour Hospital, Al-Menia Univeristy Hospital, Misr University for Science and Technology, MSKMC Univeristy Hospital

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 Incidence of surgical site infection Incidence of surgical site infection within 30 days 30 days
Secondary Hospital stay duration of hospital stay 30 days
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