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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Local Application of Collagen-Gentamicin in Addition to Fixation of the Sternum With Extra Sternal Wires for Prevention of Sternal Wound Infection in Cardiac Surgery

Conditions
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Drug Resistance, Bacterial, Postoperative Wound Infection

Intervention / Treatment
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* Drug: Local application of collagen-gentamicin
* Procedure: Fixation of the sternotomy with more than six wires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment<br>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. | Drug: Local application of collagen-gentamicin<br>* Application of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure<br>* Other names: Collatamp-G;Procedure: Fixation of the sternotomy with more than six wires<br>* At least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients |  | Within 2 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute incidence of all SWI and of superficial SWI within 2 months and the relative (the ratio) incidences of superficial vs deep SW |  | 2 months postoperatively | 
| The total incidence of SWI that requires surgical revision of the wound |  | 2 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic Prophylaxis