Chahed et al. 2014; Tunisia |
80 pts aged 3 months to 15 years, presenting within 48 hours of injury (mean TBSA 26%); SAP1 (ampicilline -clavulanic acid) = 25; SAP2 (oxacilline) = 20; NP = 35 |
Single-blind, prospective, randomized clinical trial; Level II |
Any infection (SAP1 vs SAP2 vs NP) |
Any infection: SAP1 5 pts (20%); SAP2 3 pts (15%); and NP 8 pts (23%) (p=0.70)
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This single-blind RCT showed no evidence for a reduction in any infection with the use of SAP. There was no mention of allocation concealment or intention to treat analysis. Clinicians were not blinded to SAP use. Biopsies were only done for clinical signs of infection (i.e. not on pre-selected intervals) and wound infection was not examined as a specific outcome. The study did not report patient characteristics to evaluate adequacy of randomization, the reason for markedly different numbers of patients in each group or follow-up characteristics. Patients with long pre-hospital times were excluded. |
Ugburo et al. 2004; Nigeria |
61 pts with burn presenting within 24 hours and without inhalation injury (mean TBSA 44%); SAP1 (ampicillin & cloxacillin) = 21; SAP2 (erythromycin and genticin) = 20; NP = 20 |
Prospective, randomized clinical trial; Level II |
Time to wound infection (SAP1 vs SAP2 vs NP); Proportion of infected wounds with P. aeruginosa or other organisms isolated |
Days to wound infection: SAP1 5.70 ±70, SAP2 5.75 ± 1.62 and IO 5.6 ± 1.90 (p>0.05);
P. aeruginosa isolated: SAP1 = 53% (p>0.14), SAP2 69% (p<0.001) and NP 43%. |
This RCT showed no evidence for a reduction in wound infection with use of prophylactic antibiotics. However, there was an association between SAP2 use and more frequent infection with P. aeruginosa. All groups were treated similarly and robust methods for wound infection diagnosis were used. There was no mention of allocation concealment, blinding, or intention to treat analysis. Biopsies were only done for clinical signs of infection, not on preselected intervals. The study did not report number of infections in each group or follow-up characteristics. Patients with long pre-hospital times were excluded. |
Ergün et al. 2004; Turkey |
77 pts under age 9 years, presenting within 5 days of injury (mean TBSA 14.9); SAP (mixed agents) = 47; NP = 30 |
Retrospective cohort study; Level IV |
Wound infection (SAP vs NP); LOS (SAP vs NP) |
Wound infection: SAP 10 pts (21%) vs 5 pts (17%) (p>0.05), there was no correlation with infection and day of admission (p>0.05); LOS: SAP 21.7 ± 16.4 days and NP 13.5 ± 10 days (p<0.05; see comment). |
This retrospective cohort study showed no evidence for a reduction in wound infection with use of SAP. The results are confounded by: a larger TBSA in the SAP group (mean 17.8 vs 10.4 in the NP group; p<0.01), which confounds LOS; antibiotic agent(s) used was not standardized; and, the definition of infection was a positive wound swab culture and foul smelling fluid or discoloration and clinical signs of infection. Patients were excluded |