Surgicale site infection wound infection
Conditions
Interventions
The study arm will receive the implantable gentamicin collagen sponge and the
control arm will not receive a sponge at the end of the vascular procedure
before closing the groin
Sponsors
Atrium Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of surgical site infection (SSI), including prosthetic graft infection classified according to Szilagyi, through 30 days postoperatively by a committee blinded to study allocation | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of the incision (measured postoperatively and photographed). Quantitative microbial count of skin flora immediately post-incision between two treatment groups when purulent fluid evacuates from the wound. (Isolation of bacteria in colony forming units (CFU)) Creatinine, Leukocyte numbers and CRP measured at day 1 post-operative, at discharge and at 2 weeks. Bypass patency was confirmed by noninvasive hemodynamic Doppler studies on the first postoperative day and by duplex 6 weeks after index operation. Postoperative complications are recorded. Length of hospital stay. Re-admission and reoperation. Use of intravenous or oral antibiotic during hospital stay and at home | — |
Countries
Netherlands
Outcome results
None listed