Postoperative Wound Infection
Conditions
Keywords
Wound infection, SSI, Suture
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.
Interventions
DEVICETriclosan 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.
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with leg wound infection. | 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
| Measure | Time frame |
|---|---|
| Culture-proven and antibiotic-treated wound infection after heart surgery | Within 60 days after heart surgery |
Countries
Sweden
Outcome results
None listed