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: Isolation of bacteria in colony forming units (CFU), length of hospital stay (LOS
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 MC
Eligibility
Inclusion criteria
Inclusion criteria: All patients undergoing longitudinal femoral exposure for a vascular procedure of 18 years and older.
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.
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 |
|---|---|
| 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). | — |
Contacts
Public ContactMarit Albada, van
Outcome results
None listed