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. 2016 Apr 4;2016(4):CD011586. doi: 10.1002/14651858.CD011586.pub2

Kucan 1981.

Methods Country where data collected: USA
Parallel group trial (three arms)
Unit of randomisation: participant
Unit of analysis: participant
Duration: 3 weeks
Participants Inclusion criteria: hospitalised patients with an infected PU on the sacral, ischial or femoral trochanteric areas. Infection was defined as bacterial count > 10⁵ bacteria/g tissue.
Exclusion criteria: patients with concomitant infections outside the wound, acute cellulitis surrounding the ulcer or radiographic bone involvement beneath the ulcer were excluded.
N = 45*
Mean age (years): NR; range 16 to 102. Further details not reported but no statistically significant difference between groups on age, sex, paraplegia/tetraplegia or ulcer location
Interventions Intervention arm 1: silver sulfadiazine (Silvadene cream) applied every 8 hours and covered with 2 layers fine mesh gauze
Intervention arm 2: povidone iodine (Betadine solution) saturated coarse mesh gauze dressing changed every 6 hours
Intervention arm 3: 0.9% sodium chloride solution: cleansing with sterile saline then coarse mesh gauze dressing saturated with solution, changed every 4 hours
Cointerventions: debridement of necrotic tissue as indicated. Systemic antibiotics only for intercurrent infections (15 patients received them, distributed equally).
Outcomes Secondary outcome: change in infection status (eradication of infection)
Notes *Numbers randomised to each arm were not reported, numbers analysed were reported per arm together with total number of dropouts.
Funding: NR
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “the patients were assigned to one of three treatment groups according to a computer‐generated randomized table”
Comment: computer‐generated randomisation sequence
Allocation concealment (selection bias) Unclear risk Quote: “the patients were assigned to one of three treatment groups according to a computer‐generated randomized table”
Comment: no further information to indicate concealment of allocation
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: “the biopsy specimen was delivered to the microbiologist who had no knowledge of which treatment the patient was receiving”
Comment: the assessing microbiologist was blinded to treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: “although 45 patients were included in the study initially, only 40 were finally included in the efficacy analysis. The 40 patients were divided among the treatment groups as follows: silver sulfadiazine cream, 15; povidone‐iodine solution, 11; and physiologic saline, 14”
Comment: 5/45 withdrawals but reasons for withdrawals and group allocations not reported.
Selective reporting (reporting bias) Low risk Comment: no direct quotes but all stated outcomes of interest were reported.
Other bias Low risk Comment: no direct quotes but no evidence of additional sources of bias. Systemic antibiotic therapy was assessed and did not differ between groups