Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery (LOGIX)

Region Örebro County

Status: Completed

Conditions: Drug Resistance, Bacterial; Postoperative Wound Infection

Treatments: Procedure: Fixation of the sternotomy with more than six wires; Drug: Local application of collagen-gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00484055

OFR02

Details and patient eligibility

About

The aim of the present study is to evaluate a new technique for prevention of sternal wound infection consisting of local application of collagen-gentamicin in addition to routine i.v. antibiotic prophylaxis.

The technique has been evaluated in a previous randomised study. The aim of the present study is to evaluate the technique after it has been introduced in clinical practise to monitor the bacterial antibiotic susceptibility and to verify that the suggested reduction in sternal wound infection still exits.

Full description

A new technique for prevention of sternal wound infections after cardiac surgery is studied. Local application directly in the surgical wound of aminoglycoside antibiotics (gentamicin) bound to collagen reduced the incidence of wound infection with more than 50 % in a previous prospective randomised trial.

As the technique has been introduced in clinical practise two questions need to be monitored:

• Are there signs of change in the bacteria that cause the wound infections with a shift over time towards more gentamicin resistant agents?
• Is the effect of the prophylaxis still comparable to that which was seen in the previous study?

Furthermore, results from the previous study indicated that the effect of the local antibiotic was better when combined with an extra rigid sternal wound infection, defined as at least one extra steel wire for sternal fixation.

The study is conducted at those two Swedish cardiothoracic surgery centers where it was first studied. There are thus two objectives of the study: first to analyze the microbiologic findings of the sternal wound infections that occur, and secondly to monitor the incidence of sternal wound infection (especially deep infections) when the local collagen-gentamicin prophylaxis is used in daily routine in combination with a specific surgical technique for optimization of the strength of sternal fixation.

Enrollment: 1,358 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive cardiac surgery patients operated via median sternotomy

Exclusion criteria

• Existing inclusion of the patient in another study of treatment aimed at reducing postoperative SWI.
• Known allergy or other contraindication to gentamicin or bovine collagen.
• Pregnancy or breast feeding
• Treatment with aminoglycosides during the last week

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,358 participants in 1 patient group

treatment

Active Comparator group

Description:

Use of local CollagenGentamicin and enhanced sternal fixation according to the Clinical routine introduced 4 years earlier as a result of a previous RCT on 2000 patients. In that sense these patients did not receive any intervention but just the standard treatment introduced 4 years earlier. The aim of the study was to PROSPECTIVELY include a defined number of patients to compare their complication rate with that from aControl Group of patients från a previous RCT to verify that the effect of the treatment was stable over time. As the study did not include any intervention compared to the present standard treatment at that time ethical approval was Exempt.

Treatment:

Drug: Local application of collagen-gentamicin

Procedure: Fixation of the sternotomy with more than six wires