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

Goyal 2011.

Study characteristics
Methods
  • RCT

  • Enrolment period: 1 year (not specified)

  • Country: India

  • Single centre

Participants
  • N: 200 participants

  • Age (years): range 11 to 90 yrs, with 70.5% of the patients in the 31 to 70 years age group (overall population)

  • % Men: not reported; both male and female were included

  • Inclusion criteria: any type of primary inguinal hernia.

  • Exclusion criteria: patients with complicated, strangulated hernia, those having local skin infection, systemic infection, diabetes or history of antibiotic use within previous week

  • BMI: not reported

  • Skin antiseptic: 10% povidone iodine

  • Operative time: not reported

  • Method of repair: Lichtenstein technique (hernioplasty)

  • Drain use: not reported

  • ASA class: not reported

  • Anaesthesia method: not reported

  • Hospitalisation: inpatient

  • Length of hospital stay: 1 day

  • Surgeon: not reported

Interventions
  • Prophylactic group (PG):

    • N: 100

    • antibiotic: amoxicillin‐clavulanate

    • dose: 1.2 g

    • number of doses: 1

    • route of administration: intravenous

    • timing of administration: induction

  • Control group (CG):

    • N: 100

    • substance: equal volume of sterile saline

Outcomes
  • Wound infection definition: serous discharge, seroma formation, erythema and stitch abscess.

  • Follow‐up: 8 days

  • SSSI N infected/N patients (%) PG: 1/100 (1%); CG: 3/100 (3%) (SSSI cases had erythema or stitch abscess, cases with serous discharge were considered not having wound infection)

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

  • Adverse effects: not reported

Notes
  • Patients aged < 18 years included

  • Funding was not reported.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Patients were randomized in two groups by random number table method, Group 1 as cases, Group 2 as controls”
Allocation concealment (selection bias) Unclear risk Insufficient information available.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Insufficient information available, but performance bias is unlikely in this setting
Quote: "Group 1 was given IV injection of 1,2 gr amoxicillin‐clavulanate in 20 ml saline at the time of induction, while the other group was given 20 ml of sterile saline as placebo”
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information available
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Low risk The study protocol was not registered, 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.