Key result
Prophylactic antibiotic treatment with sulbactam/ampicillin did not significantly reduce the overall incidence of wound complications compared to no prophylaxis in patients undergoing thyroid surgery (OR 0.84).
Why the study?
Does sulbactam/ampicillin prophylaxis prevent post-operatory wound infections in patients undergoing thyroidectomy?
RCT (n=500)
Double-blind
Random numbers generated by a computer
Yes
Does sulbactam/ampicillin prophylaxis prevent post-operatory wound infections in patients undergoing thyroidectomy?
Odds Ratio: 0.84 (95% CI 0.39–1.26)
p-value: p=0.23
Routine antibiotic prophylaxis with sulbactam/ampicillin does not appear beneficial for low-risk patients undergoing thyroidectomy, supporting current international guidelines.
No benefit from sulbactam/ampicillin prophylaxis in thyroid surgery; confirms guidelines against routine use in low-risk patients.
Post-operatory wound infections are a very uncommon finding after thyroidectomy. For these reasons international guidelines do not routinely recommend systemic antibiotic prophylaxis. The benefits of this antibiotic prophylaxis is not supported by clinical evidence in the literature. We have conducted a multicentric randomized double-blind trial on 500 patients who had undergone thyroidectomy for goitre or thyroid carcinoma. The 500 patients enrolled in the study (mean age 47 years) were randomized in two subgroups of 250 patients. 250 patients were treated with standard antibiotic prophylaxis with sulbactam/ampicillin 1 fl (3 gr.) 30 min before surgery. No antibiotic prophylaxis was instituted in the remainder 250 patients. Our RCT showed that prophylactic antibiotic treatment is not beneficial in patients younger than eighty years old, with no concomitant metabolic, infective and hematologic disease, with no cardiac valvulopathies, not under steroidal or immunosuppressive treatment, and not severely obese. Our study should be regarded only as a preliminary RCT, and should be followed by a study in which a larger number of patients should be enrolled so that statistically significant data can be obtained.
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Avenia et al. (2009) conducted an RCT in Goitre or thyroid carcinoma (n=500). Sulbactam/ampicillin vs. No antibiotic prophylaxis was evaluated on Comprehensive analysis of all wound complications (OR 0.84, 95% CI 0.39-1.26, p=0.23). Prophylactic antibiotic treatment with sulbactam/ampicillin did not significantly reduce the overall incidence of wound complications compared to no prophylaxis in patients undergoing thyroid surgery (OR 0.84).
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