.
Phase 1
- Conditions
- .Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2015-002559-84-FR
- Lead Sponsor
- CHU de Clermont-Ferrand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 920
Inclusion Criteria
.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 620
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
Exclusion Criteria
.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: .;Secondary Objective: .;Primary end point(s): .;Timepoint(s) of evaluation of this end point: .
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - To determine the relationship between the antibiotic prophylaxis strategy and the incidence of individual types of SSI (superficial incision infection, deep incision infection and organ-space infection) within 30 days after surgery<br>- To determine the safety of antibiotic prophylaxis (clinical adverse events)<br>- To describe the effect of SSI on postoperative complications, surgical reintervention, duration of hospital stay and postoperative mortality<br>- To determine the relationship between SSI and the time to introduction of adjuvant chemotherapy<br>;Timepoint(s) of evaluation of this end point: .