Surgical site infection wound infection
Conditions
Interventions
Pre-OP consists of a solution (5ml) of colistin sulphate 20 mg/ml and
tobramycin 16 mg/ml. The intervention starts 3 days prior to elective surgery
and is administered four times daily for 3 consecu
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 years of age or older) 2. Patients undergoing elective colorectal surgery.;Abovementioned patients may not meet any of the exclusion criteria
Exclusion criteria
Exclusion criteria: Patients who meet one or more of the following criteria will not be eligible to participate in this study:;1. Patients younger than 18 years of age 2. Legally incapacitated patients or patients who refuse to sign informed consent. 3. Patients with an inability to take oral medication 4. Patients who have undergone abdominal surgery within 30 days before randomisation 5. Patients who have a known and documented allergy to any of the medications or agents used (i.e. colistin, tobramycin or other aminoglycoside antibiotics) 6. Patients diagnosed with myasthenia gravis 7. Pregnant women and nursing mothers 8. Patients undergoing colorectal surgery in an emergency setting (i.e. not elective) 9. Patients with a stoma 10. Patients who already participated in the PreCaution trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the effect of Pre-OP, in addition to standard perioperative intravenous antimicrobial prophylaxis, in patients undergoing elective colorectal surgery, on the cumulative incidence of deep SSI and/or mortality within 30 days after colorectal surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the effect of Pre-OP, in addition to standard perioperative intravenous antimicrobial prophylaxis, in patients undergoing elective colorectal surgery on: - The cumulative incidence of deep SSI within 30 days after surgery - The all-cause mortality within 30 days after surgery - The cumulative incidence of superficial incisional SSI within 30 days after surgery - The cumulative incidence of anastomotic leakage - The all-cause mortality within 6 months after surgery - The cumulative incidence of relaparotomy within 30 days after surgery - The cumulative incidence of bacteraemia within 30 days after surgery - The cumulative incidence of infections within 30 days after surgery with highly-resistant Enterobacteriaceae (HRE) or Clostridium difficile - The presence of HRE in the intestinal flora 30 days after surgery - The postoperative length of hospital stay, including readmissions within 6 months after surgery - The postoperative length of ICU stay, including readmissions within 6 months after surgery - The in-hospital use of antibiotics within 30 days after surgery - The in-hospital costs up to 6 months after surgery - The quality of life up to 6 months after surgery 2. To identify risk factors for SSI and assess whether these are dependent on: - The type of surgery (e.g. colon versus rectum) - The use of Pre-OP (active study medication versus placebo) | — |
Countries
Netherlands
Outcome results
None listed