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NCT01019447 Clinical Trial

The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection

Surgical Site Infection Clinical Trial

Official title:
"The Impact of Using Triclosan-antibacterial Sutures on the Incidence of Surgical Site Infection" Prospective, Randomized, Controlled, Double Blind, Multi-centre Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01019447
Other study ID # INDV-0909001
Secondary ID
Status Completed
Phase Phase 4
First received November 23, 2009
Last updated June 21, 2011
Start date November 2009
Est. completion date March 2011

Study information
Verified date November 2009
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.

Recruitment information / eligibility
Status Completed
Enrollment 701
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients of different age

- Gender

- Risk factors and procedures candidate for surgical intervention during the period of the study

Exclusion Criteria:

- Patients with an established pre-operative infection at the operative site

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Vicryl Plus
Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)
• Vicryl
Polyglactin 910 antimicrobial sutures (Vicryl)

Locations
Country Name City State
Egypt Al-Zeraaein Hospital Cairo
Egypt Cairo University Kasr Al-Aini Hospital Cairo

Sponsors (2)
Lead Sponsor Collaborator
Cairo University Amygate Healthcare

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria 30 days (or 1 year in case of prosthesis) No
Secondary Post-operative hospital stay in days 30 days No
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