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Official Journal of the Italian Society of Orthopaedics and Traumatology

Table 5 GRADE evidence profile

From: Preoperative antibiotic prophylaxis and the incidence of surgical site infections in elective clean soft tissue surgery of the hand and upper limb: a systematic review and meta-analysis

Assessment of certainty of evidence

Number of patients

Effect

  

Number of studies

Study design

Risk of bias

Inconsistency

Indirection of evidence

Imprecision

Other considerations

Administration of preoperative antibiotic prophylaxis

Placebo or no drug prophylaxis

Relative risk (95% CI)

Absolute risk (95% CI)

Certainty of evidence

Importance

Surgical site infections (follow-up: from 30 to 180 days)

10a

Observational studyb

Seriousc

Not seriousd

Not seriouse

Seriousf

None

1040/102,010 (1.0%)

7694/715,299 (1.1%)

RR 1.13 (0.91–1.39)

Plus 1 per 1000 (from minus 1 to plus 4)

LOW

Critical

Serious complications secondary to SSI—not measured

Only 7 out of 10 studies included in this meta-analysis reported serious complications of surgical wounds, which accounted for 23% (24 out of 104) of postoperative SSI cases.g

Critical

Minor complications of surgical wounds—not measured

Only 2 out of 10 studies included in the meta-analysis reported minor complications of surgical wounds. Of these, 0.89% (7 out of 780) of the patients showed these complications

Important

Adverse reactions and side effects to antimicrobials—not measured

Only 1 out of 10 studies included in the systematic review (but not in the meta-analysis due to the number of events = 0) reported adverse reactions and side effects to antibiotics. Patients who received preoperative antibiotics had significantly more adverse reactions and side effects related to the administration of these drugs than patients who did not receive antibiotic prophylaxis (16.2% versus 5.5%; p = 0.029, chi-squared test). Also, 1 out of 10 patients who use antimicrobials has adverse reactions and side effects to these drugs

Important

Comparative costs of preoperative antibiotic prophylaxis—not measured

Only 1 out of 10 studies included in the meta-analysis reported costs of preoperative antibiotic prophylaxis. For each patient, the total healthcare expenses in the first 30 days after surgery (including the date of the surgical procedure) is higher when preoperative intravenous antibiotics were administered when compared to cases that did not receive these medications (US $6070 versus US $4891, respectively; p < 0.001)

Important

  1. CI confidence interval, RR relative risk
  2. aTwelve studies were included in the systematic review; of these, ten were included in the meta-analysis and two studies found no patient with SSI in the case and/or control groups
  3. bOne out of ten studies included in the systematic review was a randomized, double-blind, placebo-controlled clinical trial; nine out of ten studies, on the other hand, were nonrandomized intervention studies, which together represented a weight of 96% in the meta-analysis.
  4. cOne out of ten studies included in the meta-analysis had a low risk of bias in the RoB 2.0 tool and nine out of ten studies had a moderate risk of bias in the ROBIS-I tool, mainly due to nonblinded measurement of the outcome by potentially biased raters
  5. dThe forest plot showed partial overlapping of the confidence intervals of the studies, which are more or less similar results. Also, the statistical analyses showed chi-squared = 16.01 (df = 9; p = 0.07), I2 = 44%, and Tau2 = 0.03. The prespecified sensitivity analysis showed that heterogeneity did not impact the results
  6. eAlthough one out of ten studies excludes patients with risk factors for the occurrence of SSI, such as immunosuppression and other comorbidities, and one out of ten studies has the diagnosis of SSI inferred by the use of oral antibiotics in the postoperative period or the need for surgical re-approach, both accounted for only 10.6% weight in the meta-analysis. Likewise, these exclusions from the meta-analysis did not impact the results
  7. fDespite the high number of participants (n = 817,309), the number of events (n = 8734), and narrow 95% confidence interval (0.91–1.40), the pooled effects estimates included RR = 1 and values compatible with reduction, increase, and also absence of effect, resulting in result uncertainty
  8. gSSIs were considered serious when their treatment demanded new surgical procedures and/or hospitalization