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

Andersen 1980.

Study characteristics
Methods
  • Triple‐blind RCT

  • Country: Denmark

  • Enrolment period: April 1973 to October 1975

  • Single centre study

Participants
  • N: 285 participants

  • Age (years; mean (range)): PG: 54 to 56 years (range 21 to 82); CG: 55 years (range 20 to 82)

  • % Men: PG: 72%; CG: 73%

  • Inclusion criteria: direct hernia

  • Exclusion criteria: allergy to penicillin

  • BMI: not reported.

  • Skin antiseptic: not reported.

  • Operative time: not reported.

  • Method of repair: Mc Vay technique (herniorrhaphy)

  • Drain use: removed at postoperative day 4

  • ASA class: not reported

  • Anaesthesia method: not reported

  • Hospitalisation method: inpatient

  • Length of hospital stay: not reported

  • Surgeon: not reported

Interventions
  • Prophylactic group (PG):

    • N: 135

    • Group 1: (n = 59) Ampicillin sodium powder 1 g in the subfascial layers and silk sutures in the fascia and peritoneum

    • Group 2: (n = 76) As Group 1 but polyglycolic acid instead silk sutures

    • Timing of administration: before closure fascial

  • Control group (CG):

    • N: 150

    • Group 3: (n = 86) No antibiotic therapy and silk sutures

    • Group 4: (n = 64) No antibiotic therapy and polyglycolic acid sutures

Outcomes
  • Wound infection definition: collection of pus in the wound that requires revision

  • Follow‐up: 1, 3, 6, 12 months

  • SSSI: N infected/N patients (%) PG: 5/135 (3.7%) (Group 1: 1/59; Group 2: 4/76); CG: 6/150 (4%) (Group 3: 3/86; Group 4: 3/64

  • DSSI: not reported

  • Adverse effects: "none of the patients had an allergic reaction to ampicillin"

Notes
  • The study was realised in participants who underwent various techniques other that hernia repair, but it was possible to extract the information relating to the patients underwent to hernia repair.

  • Funding was not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information available on how "triple‐blind random allocation design" was performed
Quote: “patients … who had a direct hernia or gallstones in a gallbladder (shown not to be infected on macroscopic examination) were assigned at the end of the operation to one of the following four regimens: one gram of ampicillin powder … or no antibiotic therapy”
Allocation concealment (selection bias) Unclear risk Quote: "...were assigned at the end of the operation to one of the following four regimens:..."
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 Unclear risk No information available
Incomplete outcome data (attrition bias)
All outcomes Low risk 2 patients (out of total of 400 patients) were lost in follow‐up. Available case analysis was performed.
The proportion of missing outcomes was considered not enough to have had a clinically relevant impact on the intervention effect estimate.
Selective reporting (reporting bias) Low risk Study protocol was not registered, but report contains all expected outcomes, including specification of SSSI
Other bias Low risk The study appears to be free of other sources of bias