Cameron 1987.
Methods |
RCT Methods to control for contributory patient factors: none described |
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Participants |
Age: Group 1 (mean): 60.2 years Group 2 (mean): 61.6 years Gender: Group 1: 56.0% female Group 2: 54.5% female Type of incision: Group 1: midline 66.7%; paramedian 33.3% Group 2: midline 56.0%; paramedian 44.0% Type of surgery: Group 1: emergent 19.6%; biliary 29.8%, gastric 17.7%, colon 29.1%, other 23.4% Group 2: emergent 19.9%; biliary 32.9%, gastric 23.1%, colon 21.0%, other 23.1% Contamination classification of included participants: Group 1: clean 77.3%, clean‐contaminated 9.2%, contaminated 13.5% Group 2: clean 79.7%, clean‐contaminated 6.3%, contaminated 14.0% Pre‐operative antibiotic use: "antibiotic prophylaxis was given according to the surgeon's usual routine" Prognostic patient factors: Group 1: obesity 26%, corticosteroid use 1.4%, jaundice 3.5% Group 2: obesity 24%, corticosteroid use 2.1%, jaundice 3.5% Inclusion criteria: patients undergoing laparotomy by vertical abdominal incision Exclusion criteria: patients who were being re‐operated on via the original incision were excluded |
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Interventions |
Comparisons reported: Group 1 Suture: polypropylene (monofilament, non‐absorbable) Suturing technique: interrupted, "figure‐of‐eight" Closure method: mass Group 2: Suture: PDS (monofilament, slowly absorbable) Suturing technique: interrupted, "figure‐of‐eight" Closure method: mass Surgeon characteristics: Group 1: senior resident 56.0%, junior resident 40.4% Group 2: senior resident 52.4%, junior resident 46.8% |
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Outcomes |
Incisional hernia: no definition provided Follow‐up duration: minimum 12 months (mean 14.7 months) Wound infection: "discharge of pus, up to one month of follow‐up" Wound dehiscence: "burst abdomen" Suture sinus or fistula: no definition provided |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided |
Allocation concealment (selection bias) | Low risk | "At the end of the operation, the circulating nurse drew a sealed envelope and informed the surgeon of the suture to be used." |
Blinding (performance bias and detection bias) All outcomes | Low risk | "This assessment was 'double‐blind', as neither the examiner nor the participant knew which suture had been used." |
Incomplete outcome data (attrition bias) All outcomes | High risk | High loss to follow‐up (51/141 in group 1, 43/143 in group 2) |
Selective reporting (reporting bias) | Low risk | Hernia (at least 1 year); dehiscence and wound infection outcomes all reported |
Other bias | Low risk | The study appears to be free of other sources of bias |