Irvin 1977.
Methods |
RCT Methods to control for contributory patient factors: "The method of randomisation took into account the type of surgery performed..." |
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Participants |
Age: unknown Gender: unknown Type of incision: Group 1: median 43.2%, paramedian 56.8% Group 2: median 40.6%, paramedian 59.4% Type of surgery: Group 1: emergent 16.8%, palliative 12.6%; biliary 27.4%, peptic ulcer 30.5%, intestinal 25.3%, other 16.8% Group 2: emergent 14.6%, palliative 10.4%; biliary 35.4%, peptic ulcer 25.0%, intestinal 20.8%, other 18.8% Contamination classification of included participants: 163 "clean" wounds, 28 "infected" wounds, not broken down by group Pre‐operative antibiotic use: not described Prognostic patient factors: not reported Inclusion criteria: patients going through exploratory laparotomy through median or paramedian incisions Exclusion criteria: not described |
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Interventions |
Comparisons reported: Group 1 Sutures: polypropylene (monofilament, non‐absorbable), polyester retention sutures Suturing technique: continuous (with interrupted retention sutures) Closure method: layered Group 2: Sutures: stainless steel (monofilament, non‐absorbable) Suturing technique: interrupted, 'figure‐of‐8' Closure method: mass Surgeon characteristics: Group 1: consultant 40.0%, registrar 60.0% Group 2: consultant 43.4%, registrar 56.6% |
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Outcomes |
Incisional hernia: palpable defect in abdominal fascia with straining Follow‐up duration: 6 months Wound dehiscence: no definition provided Wound infection: discharge of pus from wound |
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Notes | Hernia data excluded from analysis due to inadequate follow‐up duration | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly allocated by drawing a trial card at the end of the abdominal procedure, and the method of randomisation took account of the type of surgery performed…" |
Allocation concealment (selection bias) | Unclear risk | "randomly allocated by drawing a trial card at the end of the abdominal procedure, and the method of randomisation took account of the type of surgery performed…" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for and dropouts adequately explained |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting |
Other bias | Low risk | The study appears to be free of other sources of bias |