PAPRAC
Trial question
Is 24-hour perioperative antibiotic prophylaxis noninferior to extended-duration perioperative antibiotic prophylaxis in patients undergoing cystectomy with urinary diversion?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 193
193 patients (59 female, 134 male).
Inclusion criteria: adult patients undergoing elective open cystectomy with urinary diversion.
Key exclusion criteria: contraindications to the class of drugs used; pregnancy or lactation; unable to follow study procedures.
Interventions
N=95 24-hour PAP (perioperative antibiotic prophylaxis for 24 hours).
N=98 extended PAP (perioperative antibiotic prophylaxis until catheters and stents are removed).
Primary outcome
Rate of surgical site infection within 90 days
8.4%
12.2%
12.2 %
9.1 %
6.1 %
3.0 %
0.0 %
24-hour
PAP
Extended
PAP
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of surgical site infection within 90 days (8.4% vs. 12.2%; ARD -3.8, 90% CI -11.1 to 3.4).
Secondary outcomes
No significant difference in death during follow-up (6.3% vs. 5.1%; RR 1.24, 95% CI -42.84 to 45.32).
No significant difference in median length of hospital stay with surgical site infection (19 days vs. 22 days; AD -3 days, 95% CI -36.38 to 30.38).
Significant decrease in median perioperative antibiotic prophylaxis duration (1 days vs. 8 days; AD -7 days, 95% CI -11.15 to -2.85).
Safety outcomes
No significant differences in adverse events, ≥ 1 febrile UTIs.
Significant difference in asymptomatic bacteriuria (25.3% vs. 16.2%).
Conclusion
In adult patients undergoing elective open cystectomy with urinary diversion, 24-hour PAP was noninferior to extended PAP with respect to the rate of surgical site infection within 90 days.
Reference
Maria C Thurnheer, Astrid Schürmann, Markus Huber et al. Perioperative Antibiotic Prophylaxis Duration in Patients Undergoing Cystectomy With Urinary Diversion: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2439382.
Open reference URL