Text Size

Effects of Triclosan-coated Sutures in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Jeppssons, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01212315
First received: September 29, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Wound Infection
 Device: Triclosan coated sutures
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Proportion of subjects with leg wound infection. [ Time Frame: Within 60 days after heartsurgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 60 days after heart surgery ] [ Designated as safety issue: No ]

Enrollment: 392
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Ordinary sutures (Vicryl / Monocryl) is used for wound closure
Active Comparator: Group A
Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure
 Device: 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.
Other Names:
  • Monocryl Plus suture
  • Vicryl Plus suture

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212315

Locations
Sweden
Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Anders Jeppsson, MD PhD Sahlgrenska Univerity Hospital
  More Information

No publications provided

Responsible Party: Anders Jeppssons, Professor, Cardiothoracic surgery, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01212315     History of Changes
Other Study ID Numbers: 001
Study First Received: September 29, 2010
Last Updated: December 19, 2012
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Sahlgrenska University Hospital, Sweden:
Wound infection
SSI
Suture

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Triclosan
Hexachlorophene
Fatty Acid Synthesis Inhibitors
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 22, 2013