Kucan 1981.
Methods | Country where data collected: USA Parallel group trial (three arms) Unit of randomisation: participant Unit of analysis: participant Duration: 3 weeks |
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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 |
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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). |
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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 |
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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 |