Back to results

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

Primary Purpose

Surgical Site Infection

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Vicryl Plus

Vicryl

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Surgical site infection, Antimicrobial triclosan-coated polyglactin 910 suture, Length of hospital stay, SSI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Al-Zeraaein Hospital
Cairo University Kasr Al-Aini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Study group

Control group

Arm Description

The study group in which Triclosan-coated polyglactin 910 antimicrobial sutures will be used.

The control group in which polyglactin 910 antimicrobial sutures will be used.

Outcomes

Primary Outcome Measures

Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria

Secondary Outcome Measures

Post-operative hospital stay in days

Full Information

NCT ID

NCT01019447

First Posted

November 23, 2009

Last Updated

June 21, 2011

Sponsor

Cairo University

Collaborators

Amygate Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT01019447

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cairo University

Collaborators

Amygate Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infection

Keywords

Surgical site infection, Antimicrobial triclosan-coated polyglactin 910 suture, Length of hospital stay, SSI

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

701 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Active Comparator

Arm Description

The study group in which Triclosan-coated polyglactin 910 antimicrobial sutures will be used.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

The control group in which polyglactin 910 antimicrobial sutures will be used.

Intervention Type

Other

Intervention Name(s)

Vicryl Plus

Other Intervention Name(s)

Triclosan-coated polyglactin 910 antimicrobial sutures

Intervention Description

Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)

Intervention Type

Other

Intervention Name(s)

Vicryl

Other Intervention Name(s)

Polyglactin 910 antimicrobial sutures

Intervention Description

Polyglactin 910 antimicrobial sutures (Vicryl)

Primary Outcome Measure Information:

Title

Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria

Time Frame

30 days (or 1 year in case of prosthesis)

Secondary Outcome Measure Information:

Title

Post-operative hospital stay in days

Time Frame

30 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ibrahim Ga Ibrahim, MD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Al-Zeraaein Hospital

City

Cairo

Country

Egypt

Facility Name

Cairo University Kasr Al-Aini Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs