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 |