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. 2017 Nov 3;2017(11):CD005661. doi: 10.1002/14651858.CD005661.pub2

Leaper 1977.

Methods RCT
Methods to control for contributory patient factors: none
Participants Age: not stated
Gender:
Group 1 female 54.3%
Group 2 female 53%
Group 3 female 46.7%
Types of incisions:
Group 1 paramedian 11.2%, midline 56.9%, transverse 31.9%
Group 2 paramedian 10.7%, midline 53.7%, transverse 35.5%
Group 3 paramedian 10%, midline 54.1%, transverse 35.8%
Types of surgery:
Group 1 colorectal 26.7%, biliary 20.7%, gastric 28.4%, miscellaneous 24.1%
Group 2 colorectal 26.4%, biliary 28.9%, gastric 22.3%, miscellaneous 22.3%
Group 3 colorectal 27.5%, biliary 25.8%, gastric 34.2%, miscellaneous 12.5%
Contamination classification of included participants:
Preoperative antibiotic use:
Prognostic patient factors:
Malignancy: Group 1 25.8%, Group 2 34.7%, Group 3 36.7%
COPD: Group 1 44%, Group 2 52%, Group 3 42%
Hypoproteinaemia: Group 1 11%, Group 2 10%, Group 3 5%
Inclusion criteria: major laparotomies
Exclusion criteria: appendectomy through muscle‐splitting incision, lumbar sympathectomy, renal bladder and prostatic surgery, incisions through previous scars
Interventions Comparisons reported:
Group 1:
 Sutures: nylon (monofilament, non‐absorbable)
 Suture technique: continuous
 Closure method: layered (peritoneum and posterior sheath closed with chromic catgut, anterior sheath by nylon)
 Group 2:
 Sutures: PGA (multifilament, fast absorbable)
 Suture technique: interrupted (Smead Jones)
 Closure method: mass closure
Group 3:
Sutures: steel (monofilament, non‐absorbable)
Suture technique: interrupted (Smead Jones)
Closure method: mass closure
Characteristics of surgeons:
Consultant: Group 1 25.8%, Group 2 28.9%, Group 3 30%
Outcomes Hernia: bulge noticeable by patient and assessor upon standing
Follow‐up duration: 6 months
Wound infection: primary sepsis is discharge of pus from a previously dry wound, secondary sepsis is acquisition of infection by a discharging wound. Major sepsis involves the deep layers of the wound and is accompanied by constitutional symptoms
Dehiscence: separation of deep layers, heralded by discharge of ascites
Sinus or fistula: not defined
Notes Hernia data excluded from analysis due to inadequate follow‐up duration
Group 2 compared with group 3 for 'absorbable versus non‐absorbable' and 'monofilament versus multifilament' as they share a common closure technique and method
Group 2 and 3 analysed together as 'interrupted', 'mass'
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation was by "means of instructions in a sealed envelope"
Allocation concealment (selection bias) Low risk Sealed envelope
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 High risk Surgeons refused randomisation in 17 cases