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

NCT ID: NCT01019447

Last Updated: 2011-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

701 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

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

Group Type ACTIVE_COMPARATOR

Vicryl Plus

Intervention Type OTHER

Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)

Control group

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

Group Type ACTIVE_COMPARATOR

Vicryl

Intervention Type OTHER

Polyglactin 910 antimicrobial sutures (Vicryl)

Interventions

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Vicryl Plus

Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)

Intervention Type OTHER

Vicryl

Polyglactin 910 antimicrobial sutures (Vicryl)

Intervention Type OTHER

Other Intervention Names

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Triclosan-coated polyglactin 910 antimicrobial sutures Polyglactin 910 antimicrobial sutures

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amygate Healthcare

UNKNOWN

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Cairo University Kasr Al-Aini Hospitals

Principal Investigators

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Ibrahim Ga Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Al-Zeraaein Hospital

Cairo, Cairo Governorate, Egypt

Site Status

Cairo University Kasr Al-Aini Hospital

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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INDV-0909001

Identifier Type: -

Identifier Source: org_study_id

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