Docobo‐Durantez 2006.
Methods |
RCT Methods to control for contributory patient factors: none described |
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Participants |
Age: Group 1: > 65 years 47.9% Group 2: > 65 years 49.2% Gender: Group 1: 47.2% female Group 2: 44.2% female Type of incision: overall, 78.1% were midline Type of surgery: Group 1: emergency 27.5% Group 2: emergency 28.2% Contamination classification of included participants: information not provided Pre‐operative antibiotic use: not described Prognostic patient factors: Group 1: malignancy 54.3%. obesity 17.1%, diabetes 18.4%, corticosteroids 4.4%, jaundice 4.2%, hypoproteinaemia 16.6%, renal failure 4.0%, ascites 1.3% Group 2: malignancy 52.7%, obesity 22.3%, diabetes 15.4%, corticosteroids 6.9%, jaundice 5.3%, hypoproteinaemia 13.8%, renal failure 5.0%, ascites 4.1% Inclusion criteria: laparotomies performed for gastrointestinal diseases and hepato‐biliopancreatic procedures (including transplant) in patients with at least 1 risk factor for wound complications: male, age > 65 years, pulmonary disease, haemodynamic instability, emergency surgery, hypoproteinaemia, clinical infection, obesity, renal failure, malignancy, ascites, steroids, hypertension, anaemia, jaundice or diabetes Exclusion criteria: hernia repair surgery, bariatric surgery, need for reinforcement sutures, uncommon incisions (including paramedian and McBurney incisions), life expectancy of < 1.5 years and deaths unrelated to wounds |
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Interventions |
Comparisons reported: Group 1 Suture: PDS (monofilament, slowly absorbable) Suturing technique: continuous Closure method: mass Group 2: Suture: nylon (monofilament, non‐absorbable) Suturing technique: continuous Closure method: mass Surgeon characteristics: information not provided |
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Outcomes |
Incisional hernia: no definition provided Follow‐up duration: 3, 6, 12 and 18 months Wound infection: "as per the Center for Disease Control (CDC) definition for surgical site infection" Dehiscence: no definition provided |
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Notes | Extremely high loss to follow‐up. Hernia data at 1 year used in analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation tables created |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only 104/451 in PDS group and 72/319 in nylon group followed up at 1 year |
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 |