The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study
- Conditions
- Rectal cancer, Anal canal cancer
- Registration Number
- JPRN-UMIN000042658
- Lead Sponsor
- Tokyo Medical and Dental University Department of Gastrointestinal Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
Not provided
Patients who meet any of the following conditions are not eligible (1) Patients with previous hypersensitivity to SBT/ABPC or CMZ (2) Emergency surgery (3) Patients with poorly controlled diabetes (HbA1c over 8.0), chronic renal failure requiring dialysis, and patients requiring immunosuppressive drugs (4) Patients with a systemic active infection or fever (>38 degrees Celsius) and suspected infection (5) Patients who are either pregnant, likely to be pregnant, within 28 days after delivery, or breastfeeding (6) Serious organ failure (7) As a result of preoperative explanations, cases of disagreement (8) Any other patient whom the principal investigator or the researcher determines to be unsuitable for the safe conduct of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of perineal wound infection within 30 days after surgery
- Secondary Outcome Measures
Name Time Method 1 Incidence of all SSI(surgical site infection) 2 Percentage of all complications, excluding SSI, within 30 days of surgery. 3 Methicillin-resistant Staphylococcus Aureus (MRSA) detection rate 4 Post-operative hospital stay