Postoperative Wound Infection Clinical Trial
Official title:
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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