colorectal surgery
Conditions
Interventions
Trade Name: Cefoxitin 1g
Product Name: Cefoxitin
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Cefoxitin
CAS Number: 33564-30-6
Current Sponsor code: Cefoxitin
Other descriptive name:
Sponsors
CHU de Poitiers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adult patients (=18 years) -Undergoing colorectal surgery (predictable duration > 90 min) -Patients benefiting from a Social Security system or benefiting from it through a third party -Free subject, without guardianship or curatorship or subordination -Having given their informed consent 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 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: -Patients with known history of hypersensitivity to cefoxitin or others beta-lactams -Patients with severe obesity (defined by a body mass index greater than 35 kg/m2) -Patients with severe renal insufficiency (clearance creatinine < 30ml/min) -Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis -Participation to another clinical trial aimed at reducing SSI -Patients already previously enrolled in this study -Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy) -Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery. ;Secondary Objective: 1.Incidence of individual types of SSI, 2.Incidence of surgical reintervention, 3.Incidence of anastomotic leak 4.Incidence of postoperative complication according to the Dindo and Clavien classification 5.Incidence of Clostridium difficile infection 6.Incidence of hospital readmission 7.Incidence of unexpected admission to the ICU 8.Duration of hospital stay 9.Postoperative mortality 10.Adverse events during the antibiotic administration ;Primary end point(s): Proportion of patients with any SSI within 30 days after surgery. ;Timepoint(s) of evaluation of this end point: 30 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection) 2.Proportion of patients with surgical reintervention 3.Proportion of patients with anastomotic leak 4.Proportion of patients with postoperative complication according to the Dindo and Clavien classification 5.Proportion of patients with Clostridium difficile infection 6.Hospital readmission censored at day 30 7.Unexpected admission to the ICU censored at day 30 8.Duration of hospital stay and hospital free days 9.All-causes mortality 10.Proportion of per operative adverse events ;Timepoint(s) of evaluation of this end point: at most in the 30 days after surgery. | — |
Countries
France
Contacts
Public ContactFanny ABRIAT
CHU de Poitiers
Outcome results
None listed