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Completed

NCT Number: NCT01212315

Effects of Triclosan-coated Sutures in Cardiac Surgery

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.

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Key information

Conditions

Postoperative Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triclosan coated sutures

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.

Other names: Monocryl Plus suture, Vicryl Plus suture

Primary outcomes

  1. Proportion of subjects with leg wound infection.

    Time frame: Within 60 days after heartsurgery

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

Secondary outcomes

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

    Time frame: Within 60 days after heart surgery

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2010
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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