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Effects of Triclosan-coated Sutures in Cardiac Surgery

Primary Purpose

Postoperative Wound Infection

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Triclosan coated sutures

About this trial

This is an interventional treatment trial for Postoperative Wound Infection focused on measuring Wound infection, SSI, Suture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Group A

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01212315

First Posted

September 29, 2010

Last Updated

December 19, 2012

Sponsor

Sahlgrenska University Hospital, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT01212315

Brief Title

Effects of Triclosan-coated Sutures in Cardiac Surgery

Official Title

Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The role of the suture material for the development of postoperative wound infection has been debated for many years. It has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after CABG.

6. Conditions and Keywords

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

Postoperative Wound Infection

Keywords

Wound infection, SSI, Suture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

392 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Triclosan coated sutures

Other Intervention Name(s)

Monocryl Plus suture, Vicryl Plus suture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of subjects with leg wound infection.

Description

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

Time Frame

Within 60 days after heartsurgery

Secondary Outcome Measure Information:

Title

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

Time Frame

Within 60 days after heart surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included. Exclusion Criteria: Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Jeppsson, MD PhD

Organizational Affiliation

Sahlgrenska Univerity Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

City

Gothenburg

ZIP/Postal Code

413 45

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

26432552

Citation

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.

Results Reference

derived

PubMed Identifier

23435526

Citation

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.

Results Reference

derived

Learn more about this trial

Effects of Triclosan-coated Sutures in Cardiac Surgery

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