ASSIT
Trial question
Is extended-course antibiotic prophylaxis superior to short-course antibiotic prophylaxis in patients with lower limb amputation?
Study design
Single center
Single blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 152
152 patients (42 female, 110 male)
Inclusion criteria: adult patients undergoing minor and major lower limb amputation
Key exclusion criteria: known allergy to chlorhexidine/alcohol/iodophors; severe sepsis secondary to gas gangrene requiring multiple operations and admission to ICU; toe amputations
Interventions
N=76 extended-course antibiotic prophylaxis (5-day antibiotic course)
N=76 short-course antibiotic prophylaxis (24-hour antibiotic course)
Primary outcome
Surgical site infections at 30 days
11.8
39.5
39.5 %
29.6 %
19.8 %
9.9 %
0.0 %
Extended-course antibiotic prophylaxis
Short-course antibiotic prophylaxis
Significant decrease ▼
NNT = 3
Significant decrease in surgical site infections at 30 days (11.8% vs. 39.5%; ARD -27.7, 95% CI -44.14 to -11.26)
Secondary outcomes
Significant decrease in impaired wound healing (22.4% vs. 58%; RR 0.39, 95% CI 0.16 to 0.62)
No significant difference in median duration of hospital stay (14 days vs. 15 days; AD -1 days, 95% CI -4.89 to 2.89)
Significant decrease in patients who had to return to the theater (6.6% vs. 21%; ARD -14.4, 95% CI -25.36 to -3.44)
Safety outcomes
No significant differences in death from any cause at 1 year, ICU admission, transfusion of blood products.
Conclusion
In adult patients undergoing minor and major lower limb amputation, extended-course antibiotic prophylaxis were superior to short-course antibiotic prophylaxis with respect to surgical site infections at 30 days.
Reference
Panayiotis Souroullas, Rachel Barnes, Daniel Carradice et al. Extended-course antibiotic prophylaxis in lower limb amputation: randomized clinical trial. Br J Surg. 2022 Apr 19;109(5):426-432.
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