Drug Resistance, Bacterial, Postoperative Wound Infection
Conditions
Keywords
Antibiotic Prophylaxis
Brief summary
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
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.
Interventions
DRUGLocal application of collagen-gentamicin
Application of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure
PROCEDUREFixation of the sternotomy with more than six wires
At least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure
Sponsors
University Hospital, Linkoeping
Region Örebro County
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Sweden
Outcome results
None listed