| Study characteristics |
| Methods |
|
| 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 |
N: 100
antibiotic: amoxicillin‐clavulanate
dose: 1.2 g
number of doses: 1
route of administration: intravenous
timing of administration: induction
|
| 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 |
|
| 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. |