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. 2020 Apr 21;2020(4):CD003769. doi: 10.1002/14651858.CD003769.pub5

Kochhar 2014.

Study characteristics
Methods
  • Double‐blind RCT

  • Enrolment period: August 2007 to December 2012

  • Country: India

  • Single centre

Participants
  • N: 217 participants

  • Age (years; mean ± SD): PG: 37.42 ± 9.9; CG: 37.42 ± 11.5

  • % Men: 95.7% (overall study population)

  • Inclusion criteria: unilateral or bilateral inguinal hernia, age 15 to 70 years

  • Exclusion criteria: Patients allergic to the given antibiotic, recurrent hernia, strangulated hernia, pregnancy or lactation, an immune compromised state, antibiotic treatment within last 5 days, existing indication for antibiotic prophylaxis (i.e. valvular heart disease)

  • BMI: not reported

  • Skin antiseptic: not reported

  • Operative time: not reported

  • Method of repair: Lichtenstein technique with monofilament polypropylene mesh (hernioplasty)

  • Drain use: not reported

  • ASA class: not reported

  • Anaesthesia method: not reported

  • Hospitalisation method: inpatient

  • Length of hospital stay: 1 day

  • Surgeon: not reported

Interventions
  • Prophylactic group (PG):

    • N: 109

    • antibiotic: amoxicillin clavulanic acid

    • dose: 1.2 g

    • number of doses: 1

    • route of administration: intravenous

    • timing of administration: just before operation

  • Control group (CG):

    • N = 108

    • substance: equal volume of sterile saline

Outcomes
  • Wound infection definition: ASEPSIS criteria purulent discharge, erythema, wound breakdown)

  • Follow‐up: 1 and 4 weeks

  • SSSI N infected/N patients (%): PG: 4/106 (3.8%); CG: 5/106 (4.7%)

  • DSSI: not reported (reported: "not necessary to remove any mesh")

  • Adverse effects: not reported

Notes
  • Participants < 18 years old were included in this study

  • Staphylococcus aureus, E. coli, Klepsiella pneumoniae bacteria were isolated from the wound infections

  • Funding: nil.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “All patients were randomized to either intravenous placebo (control group) or antibiotic prophylaxis (study group) by block randomization”. No information on how randomisation was accomplished. However, the block randomisation method indicates that the randomisation methodology has been performed carefully to minimise bias.
Allocation concealment (selection bias) Unclear risk No information available
Blinding of participants and personnel (performance bias)
All outcomes Low risk No information available, but performance bias is unlikely in this setting
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: “Surgeon who was not involved in surgery followed the case after 1 and 4 weeks post‐operatively”
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing outcome data balanced in numbers across intervention groups, with similar reason for missing data. The proportion of missing outcomes was considered not enough to have had a clinically relevant impact on the intervention effect estimate.
Quote: “Out of the total study population 3 patients from the study and 2 patients from the control group were excluded postoperatively for development of URI and thus requirement of antibiotics.” Available‐case analysis was performed.
Selective reporting (reporting bias) Low risk The study protocol was not available but report includes all expected outcomes, including specification of SSSI
Other bias Low risk The study appears to be free of other sources of bias