SiSi-trial.

Recruiting

• Conditions: 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; in days), readmission, reoperation, antibiotics during hospital stay and at home (in days).

• Registration Number: NL-OMON28917
• Lead Sponsor: Atrium MC

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 608

Inclusion Criteria

All patients undergoing longitudinal femoral exposure for a vascular procedure of 18 years and older.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).