PREVENTION OF SURGICAL SITE INFECTION AT THE GROIN AFTER FEMORAL ARTERIAL EXPOSURE USING LOCAL GENTAMYCIN SPONGE PROSPECTIVE, RANDOMISED, CONTROLLED TRIA

Recruiting

Conditions: Surgicale site infection
wound infection
10003184

Registration Number: NL-OMON38160

Lead Sponsor: Atrium Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 608

Inclusion Criteria

All patients undergoing femoral incision for primary arterial repair.
Patients are 18 years or older, and both sexes can participate.
Signed informed consent

Exclusion Criteria

Patients known with a sensitivity or allergy to gentamicin.
Patients pregnant or breast feeding.
In case of bilateral groin dissection for vascular surgery, the left groin is excluded.
Patients undergoing femoral incision for endovascular procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of surgical site infection (SSI), including prosthetic graft<br /><br>infection classified according to Szilagyi, through 30 days postoperatively by<br /><br>a committee blinded to study allocation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Length of the incision (measured postoperatively and photographed).<br /><br>Quantitative microbial count of skin flora immediately post-incision between<br /><br>two treatment groups when purulent fluid evacuates from the wound. (Isolation<br /><br>of bacteria in colony forming units (CFU))<br /><br>Creatinine, Leukocyte numbers and CRP measured at day 1 post-operative, at<br /><br>discharge and at 2 weeks.<br /><br>Bypass patency was confirmed by noninvasive hemodynamic Doppler studies on the<br /><br>first postoperative day and by duplex 6 weeks after index operation.<br /><br>Postoperative complications are recorded.<br /><br>Length of hospital stay.<br /><br>Re-admission and reoperation.<br /><br>Use of intravenous or oral antibiotic during hospital stay and at home</p><br>