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. 2021 Jul 26;2021(7):CD013397. doi: 10.1002/14651858.CD013397.pub2

Eriksson 1984a.

Study characteristics
Methods Study objective: to evaluate different methods of topical treatment of venous leg ulcers
Trial design (e.g. parallel group) including research sites: parallel group
Follow‐up period: 8 weeks
Number of arms: 3
Study start date and end date: not given
Care setting: not reported
Participants Study population: people with venous leg ulcers.
Eligibilitycriteria: exclusion criteria are overt diabetes mellitus, manifest arterial insufficiency, clinical picture of erysipelas or cellulitis
Sex (M:F): overall 13:40 (among all 53 participants who were enrolled in an unrelated trial prior to the compression trial)
Age (years): mean 70.1 (among all 53 participants who were enrolled in an unrelated trial prior to the compression trial)
Duration of leg ulcers: not reported
Baseline leg ulcer area: not reported
Group difference: comparable in terms of all variables except for high blood glucose levels, and history of previous thrombosis (among participants of the trial 1)
Total number of participants: 44 participants in the compression trial
Unit of analysis (including number of ulcers per person): participants
Unit of randomisation (e.g. leg ulcer, limb, or participant): participants
Interventions Intervention characteristics
Porcine skin dressing
  • Details of interventions (including compression devices used, and duration of interventions applied): Skin‐tec(R) (Astra‐Syntex, Sweden) applied to the ulcer after cleaning with saline. Treatment stopped during the study as the dressing was no longer available. Double‐layer bandage then introduced

  • Descriptions of any co‐interventions or standard care: none reported

  • Number of participants randomised: n = 11 participants

  • Number of participants analysed: not given


Metallina aluminium foil dressing
  • Details of interventions (including compression devices used, and duration of interventions applied): Metalline® dressing has an aluminium surface and changed in the same manner as the porcine skin. Applied throughout the study

  • Descriptions of any co‐interventions or standard care: none reported

  • Number of participants randomised: n = 20 participants

  • Number of participants analysed: not given


Double‐layer bandage
  • Details of interventions (including compression devices used, and duration of interventions applied): consisted of an inner stocking impregnated with a zinc oxide paste (ACO, Sweden) and an outer elastic bandage (Tensoplast, Smith & Nephew Ltd., GB). Applied in place for 1 ‐ 2 weeks at a time

  • Descriptions of any co‐interventions or standard care: not reported

  • Number of participants randomised: n = 13 participants

  • Number of participants analysed: not given

Outcomes Time‐to‐complete wound healing
  • Not reported


Proportion of wounds completely healed during follow‐up
  • Not reported


Adverse events
  • Notes: 6 participants treated by aluminium foil stopped before the end of the study because of poor effect (ulcer size increase or infections, or both). No case abandoned in double‐layer bandage and compression did not give any symptoms of peripheral arterial circulatory insufficiency


Participant health‐related quality of life/health status
  • Not reported


Cost effectiveness
  • Notes: Porcine skin expensive but double‐layer bandage comparatively cheap


Mean pain score
  • Not reported


Outcomes that are not considered in this review but reported in trials:
  • The area size and volume of the ulcers at 4 weeks

Identification Publication type/ status (e.g. conference abstract): full paper
Trial protocol: not reported
Source of funding: not described
Country of origin: Sweden
Contact information: G. Eriksson, Departments of Dermatology, Dandeyd Hospital, Stockholm, Sweden
Notes Eriksson 1984a presented results of 2 trials: the 2‐week trial 1 compared 0.9% sodium chloride in sterile water with dextranomer beads through randomising 53 participants with venous leg ulcers and 9 patients excluded because of ulcer healing or reasons unrelated to the trial 2 prior to the conduct of trial 2. With the remaining 44 participants, trial 2 was undertaken to compare 2 dressing methods with a compression bandage method. Only data from trial 2 were extracted for this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... the patients were randomised for three different treatments."
Comment: unclear risk of bias because the randomisation method is not described
Allocation concealment (selection bias) Unclear risk Comment: no information provided
Blinding of participants and personnel (performance bias)
All outcomes High risk Outcome group: ulcer healing
Quote: "The investigation was designed as a randomised open trial"
Comment: high risk of bias because this trial is claimed to be "open" label.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome group: ulcer healing
Quote: "Stereophotogrammetry was used as an objective method of measurement of the healing process"
Comment: low risk of bias because ulcer outcomes are measured using the objective stereophotogrammetry as the authors claim
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: no information provided.
Selective reporting (reporting bias) Low risk Comment: the authors claimed to evaluate time to ulcer healing but did not present relevant data. The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified
Other bias Low risk Comment: the study appears to be free of other sources of bias.