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Effects of Triclosan-coated Sutures in Cardiac Surgery

NCT ID: NCT01212315

Last Updated: 2012-12-20

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

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Postoperative Wound Infection

Keywords

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Wound infection SSI Suture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group A

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

Group Type ACTIVE_COMPARATOR

Triclosan coated sutures

Intervention Type DEVICE

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.

Interventions

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Triclosan coated sutures

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.

Intervention Type DEVICE

Other Intervention Names

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Monocryl Plus suture Vicryl Plus suture

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Jeppssons

Professor, Cardiothoracic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Jeppsson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Univerity Hospital

Locations

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Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 26432552 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23435526 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id