BACKGROUND: There are few randomized clinical trials that prove the effectiveness of antibiotic prophylaxis (AP) to prevent pediatric surgical site infections (SSI). We undertook this study to determine the effectiveness of AP vs. traditional scheme of antibiotics. METHODS: We carried out a randomized clinical trial at the General Surgery Department of a Tertiary Care Children's Hospital in Mexico City. There were 187 consecutive patients, age 18 years or less, with clean or clean-contaminated procedures performed between January 2005 and December 2006. Exclusion criteria included previous scar on operated site, receiving antibiotics, or no informed consent. Cefalotin or clindamycin plus amikacin was administered 2 h before incision, continued for just 24 h in the experimental group (EG) vs. cefalotin or clindamycin plus amikacin administered just before, during or after incision and continuing for 5 days (control group, CG). RESULTS:Sixteen patients were excluded. EG included 26 clean and 54 clean-contaminated procedures, and in the CG there were 27 and 64 procedures, respectively. EG had a lower incidence of SSI (1/80 [1.2 %] vs. 10/91 [10.9 %], RR 9.7, (95% CI: 1.2-77.9, p = 0.009). The difference is based mainly on the clean-contaminated procedures. CONCLUSIONS: AP administered 2 h before incision and continuing for 24 h significantly decreases the risk of SSI compared to CG in clean-contaminated procedures.
RCT Entities:
BACKGROUND: There are few randomized clinical trials that prove the effectiveness of antibiotic prophylaxis (AP) to prevent pediatric surgical site infections (SSI). We undertook this study to determine the effectiveness of AP vs. traditional scheme of antibiotics. METHODS: We carried out a randomized clinical trial at the General Surgery Department of a Tertiary Care Children's Hospital in Mexico City. There were 187 consecutive patients, age 18 years or less, with clean or clean-contaminated procedures performed between January 2005 and December 2006. Exclusion criteria included previous scar on operated site, receiving antibiotics, or no informed consent. Cefalotin or clindamycin plus amikacin was administered 2 h before incision, continued for just 24 h in the experimental group (EG) vs. cefalotin or clindamycin plus amikacin administered just before, during or after incision and continuing for 5 days (control group, CG). RESULTS: Sixteen patients were excluded. EG included 26 clean and 54 clean-contaminated procedures, and in the CG there were 27 and 64 procedures, respectively. EG had a lower incidence of SSI (1/80 [1.2 %] vs. 10/91 [10.9 %], RR 9.7, (95% CI: 1.2-77.9, p = 0.009). The difference is based mainly on the clean-contaminated procedures. CONCLUSIONS: AP administered 2 h before incision and continuing for 24 h significantly decreases the risk of SSI compared to CG in clean-contaminated procedures.