SiSi-trial.

Rationale:

Despite the routine use of prophylactic systemic antibiotics, inguinal surgical site infection still occurs in 4-44[1-5]% in patients undergoing femoral exposure for central or peripheral arterial disease and is associated with significant excess morbidity, mortality, and costs. A large, 2-center, randomized trial in Sweden reported in 2005 that a gentamicin-collagen sponge, a surgically implantable topical antibiotic, reduced surgical site infection by 50% in patients undergoing cardiac bypass surgery.


The aim of this study is to test the hypothesis that a gentamicin-collagen sponge reduces the incidence of surgical site infection (SSI) in patients undergoing inguinal dissection for vascular reconstruction.



Objective:

Primary endpoint: 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. The primary study comparison will be done in the intention-to-treat population.

Secondary endpoints: Creatinin, Leukocyte numbers and CRP, Isolation of bacteria in colony forming units (CFU), length of hospital stay (LOS; in days), readmission, reoperation, antibiotics during hospital stay and at home (in days).



Study design:

The study is designed as a prospective, randomized, controlled trial.



Study population:

All patients undergoing femoral exposure for a vascular procedure of 18 years and older. Excluding endovascular approach. 608 patients will be recruited.



Intervention:

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.



Main study parameters/endpoints:

The main study parameter is the incidence of surgical site infections at the groin at day 30. A reduction of 50% is hypothesized.

The main study parameter is the incidence of surgical site infections at the groin at day 30. A reduction of 50% is hypothesized.

1. Pre-op;

2. Operation;

3. Day 1;

4. Discharge;

5. Week 2;

6. Week 4;

7. Week 6.

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.