Effects of Triclosan-coated Sutures in Cardiac Surgery

Sahlgrenska University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Wound Infection

Treatments: Device: Triclosan coated sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT01212315

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 392 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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392 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Group A

Active Comparator group

Description:

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

Treatment:

Device: Triclosan coated sutures