Eriksson 1986.
Methods | RCT, open design. Outpatient setting in Sweden. | |
Participants | 34 outpatients with chronic venous leg ulcers (9 males,mean age 66.9 years; 25 females, mean age 74.3 years). 3 diabetic patients in Group 2. Inclusion and exclusion criteria not specified. |
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Interventions | All patients: ulcerated limb immersed for 15 minutes in a bath of tepid potassium permanganate solution, then crusts and debris removed. Group 1: inner stocking impregnated with zinc oxide paste (ACO) plus an outer elastic bandage (Tensoplast or Porelast Acryl). Bandages changed every 1‐2 weeks (n = 17). Group 2: hydrocolloid dressing (Duoderm) plus elastic bandage (Wero). Dressing renewed 1‐2 times/week. Bandage removed at night and reapplied in the morning by patients (n = 17). |
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Outcomes | Number (%) patients with complete healing at 12 weeks: Group 1: 7/17 (41%); Group 2: 9/17 (53%). Statistical tests not reported. Mean decrease in ulcer area:volume at 12 weeks: Group 1: 75%:75%; Group 2: 70%:55% (NB: values recorded from figure; all between‐group differences reported as not statistically significant, but P values not shown). Number (%) patients who discontinued treatment (with reasons): Group 1: 3/17 (18%) (1 withdrew, 2 had infection of peri‐ulcer skin); Group 2: 2/17 (12%) (1 withdrew, 1 had enlargement of study ulcer and development of new ulcer). |
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Notes | Ulcer area and volume measured using stereophotogrammetry every 2 weeks. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The study was designed as a randomised open trial . . .". |
Allocation concealment (selection bias) | Unclear risk | "The study was designed as a randomised open trial . . .". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | For healed outcome, only numerators given, therefore unclear whether all patients followed‐up. Numbers for continuous outcomes unclear. |
Blinded outcome assessment (healing) | Unclear risk | Not stated. |
Baseline comparability | Unclear risk | No baseline data reported. |