NCT01212315

Brief Summary

The purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
392

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

March 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

3.3 years

First QC Date

September 29, 2010

Last Update Submit

December 19, 2012

Conditions

Postoperative Wound Infection

Keywords

Wound infectionSSISuture

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with leg wound infection.

    Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.

    Within 60 days after heartsurgery

Secondary Outcomes (1)

  • Culture-proven and antibiotic-treated wound infection after heart surgery

    Within 60 days after heart surgery

Study Arms (2)

Control group

NO INTERVENTION

Ordinary sutures (Vicryl / Monocryl) is used for wound closure

Group A

ACTIVE COMPARATOR

Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure

Device: Triclosan coated sutures

Interventions

Triclosan coated suturesDEVICE

Subcutaneous and cutaneous sutures coated with triclosan (Vicryl Plus / Monocryl Plus) are used to close the incisions after vein harvesting and sternotomy. All wounds are inspected before discharge from hospital and the patients are instructed to contact the study coordinator if any suspected infection occurs. In addition, all patients are controlled after thirty days by a nurse and contacted by telephone sixty days after surgery to assess postoperative infections by a predefined questionnaire. Infection symptoms are graded according to the Asepsis score and the CDC classification. Patient records including bacterial cultures and antibiotic treatment are collected for all patients with suspected infections.

Also known as: Monocryl Plus suture, Vicryl Plus suture
Group A

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.

You may not qualify if:

  • Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (2)

  • Steingrimsson S, Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial. Eur J Clin Microbiol Infect Dis. 2015 Dec;34(12):2331-8. doi: 10.1007/s10096-015-2485-8. Epub 2015 Oct 2.

    PMID: 26432552DERIVED

  • Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial. Eur J Cardiothorac Surg. 2013 Nov;44(5):931-8. doi: 10.1093/ejcts/ezt063. Epub 2013 Feb 22.

    PMID: 23435526DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionWound Infection

Interventions

Sutures

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Anders Jeppsson, MD PhD

    Sahlgrenska Univerity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Cardiothoracic surgery

Study Record Dates

First Submitted

September 29, 2010

First Posted

September 30, 2010

Study Start

March 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

SE(1)