Effects of Triclosan-coated Sutures in Cardiac Surgery
This study has been completed.
Sponsor:
Sahlgrenska University Hospital, Sweden
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
| Tracking Information | |||||
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| First Received Date ICMJE | September 29, 2010 | ||||
| Last Updated Date | December 19, 2012 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Proportion of subjects with leg wound infection. [ Time Frame: 60 days ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01212315 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Culture-proven and antibiotic-treated wound infection after heart surgery [ Time Frame: Within 60 days after heart surgery ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Triclosan-coated Sutures in Cardiac Surgery | ||||
| Official Title ICMJE | Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Postoperative Wound Infection | ||||
| Intervention ICMJE | 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:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 392 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01212315 | ||||
| Other Study ID Numbers ICMJE | 001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Anders Jeppssons, Sahlgrenska University Hospital, Sweden | ||||
| Study Sponsor ICMJE | Sahlgrenska University Hospital, Sweden | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sahlgrenska University Hospital, Sweden | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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