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. 2013 Jan 31;2013(1):CD001737. doi: 10.1002/14651858.CD001737.pub4

Lindgren 1998.

Methods RCT with 8 weeks' treatment. Method of randomisation: unclear.
Participants 27 participants with venous ulcers treated in outpatient department 
 Groups matched at baseline for age, sex, ulcer duration and mean ulcer area
Interventions Group 1: (n = 15) cryopreserved allografts, dressing (Mepitel) and compression 
 Group 2: (n = 12) dressing (Mepitel) and compression
Outcomes a) Number with ulcer healed at 8 weeks: 
 Group 1: = 2/15 
 Group 2: = 2/12 
 b) Number with a reduction in ulcer area: 
 Group 1: = 8/15 
 Group 2: = 6/12
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “…randomised to two groups”
Comment: randomisation mentioned however no method outlined
Allocation concealment (selection bias) Unclear risk Comment: not stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "two patients in each group were excluded as the end stage of healing produced multiple small wounds not allowing analysis with this method"
Comment: 4 patients excluded which comprises 12% of the total sample. Assumed to be low risk due to small proportion of the total.
Selective reporting (reporting bias) Low risk Comment: all primary outcomes reported adequately (wound healing as percentage of initial wound area)
Other bias Unclear risk Comment: all variables balanced except mean initial wound area (4.4 cm² vs 7.9 cm²). It is unclear what impact, if any, this can have on the data.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: not stated
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: not stated