Fagniez 1985.
Methods |
RCT Methods to control for contributory patient factors: |
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Participants |
Age: Group 1 (mean): 54 years Group 2 (mean): 53 years Gender: Group 1: 55.0% female Group 2: 58.7% female Type of incision: Group 1: upper midline 55.1%; lower midline 32.7%; central midline 6.9%; complete midline 5.3% Group 2: upper midline 54.9%; lower midline 32.7%; central midline 6.8%; complete midline 5.6% Type of surgery: not reported Contamination classification of included participants: Group 1: clean 32.6%; clean‐contaminated 42.6%; contaminated 25.0% Group 2: clean 32.6%; clean‐contaminated 42.3%; contaminated 24.7% Pre‐operative antibiotic use: Group 1: 16.7% Group 2: 17.1% Prognostic patient factors: Group 1: obesity 11.9% Group 2: obesity 12.5% Inclusion criteria: all patients operated on who received a midline abdominal incision for any indication Exclusion criteria: patients operated on with incisions other than midline abdominal were excluded |
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Interventions |
Comparisons reported: Group 1: Sutures: PGA (multifilament, fast absorbable) Suture technique: interrupted Closure method: mass Group 2: Sutures: PGA (multifilament, fast absorbable) Suture technique: continuous Closure method: mass Surgeon characteristics: not reported |
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Outcomes |
Incisional hernia: not defined Follow‐up duration: unclear, but suggests 30 days Wound infection: "Wound abscess" Dehiscence: not defined Sinus or fistula: not defined |
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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 | Not described |
Allocation concealment (selection bias) | Low risk | Sealed form opened by nurse at time of surgery |
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 analysed |
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 |