NCT01019447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
701

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

November 23, 2009

Last Update Submit

June 21, 2011

Conditions

Surgical Site Infection

Keywords

Surgical site infectionAntimicrobial triclosan-coated polyglactin 910 sutureLength of hospital staySSI

Outcome Measures

Primary Outcomes (1)

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

    30 days (or 1 year in case of prosthesis)

Secondary Outcomes (1)

  • Post-operative hospital stay in days

    30 days

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Other: Vicryl Plus

Control group

ACTIVE COMPARATOR

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

Other: Vicryl

Interventions

Vicryl PlusOTHER

Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)

Also known as: Triclosan-coated polyglactin 910 antimicrobial sutures
Study group
VicrylOTHER

Polyglactin 910 antimicrobial sutures (Vicryl)

Also known as: Polyglactin 910 antimicrobial sutures
Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients of different age
  • Gender
  • Risk factors and procedures candidate for surgical intervention during the period of the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Zeraaein Hospital

Cairo, Cairo Governorate, Egypt

Location

Cairo University Kasr Al-Aini Hospital

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Polyglactin 910

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyestersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ibrahim Ga Ibrahim, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 22, 2011

Record last verified: 2009-11

Locations

EG(2)