Groenewald 1984.

Study characteristics
Methods	Study objective: to compare hydrocolloid dressings with conventional treatment (compression bandage) for the treatment of venous leg ulcers Trial design (e.g. parallel group) including research sites: parallel group Follow‐up period: 8 weeks Number of arms: 2 Study start date and end date: not given Care setting: outpatient setting
Participants	Study population: people with venous stasis ulcers Eligibilitycriteria: not given Sex (M:F): overall ratio 1:3 among overall clinic population (not for eligible participants) Age (years): not described Duration of leg ulcers: some with recent onset; most with more than 6 months and some for many years Baseline leg ulcer area: not given Group difference: not given Total number of participants: 72 participants Unit of analysis (including number of ulcers per person): participants Unit of randomisation (e.g. leg ulcer, limb, or participant): participants
Interventions	Intervention characteristics Hydrocolloid dressings Details of interventions (including compression devices used, and duration of interventions applied): skin cleansing performed in the same way as control group plus hydrocolloid dressing applied according to the prescribed procedure Descriptions of any co‐interventions or standard care: see conventional treatment Number of participants randomised: n = 36 participants Number of participants analysed: not given Conventional treatment (compression bandage) Details of interventions (including compression devices used, and duration of interventions applied): skin cleansing (washing ulcers and surrounding area with povidone‐iodine solution and povidone‐iodine ointment swabbed) plus compression bandage consisted of a 2.5 cm‐thick foam rubber pad placed directly over the ulcerated and immediately surrounding area, while the foot and lower leg were bound with a zinc oxide‐impregnated gauze band covered by an elastic bandage Descriptions of any co‐interventions or standard care: as above Number of participants randomised: n = 36 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: "Few unfavourable effects were recorded during the trial in the patients treated with hydrocolloid dressings." "An increased tendency toward fungus infections was noted in some cases treated with hydrocolloid dressings." 7 of 36 withdrew in hydrocolloid dressing due to non‐compliance (n = 2) and treatment stopped (n = 5 including 2 having pain and irritation and 3 with overwhelming sepsis); 6 of 36 withdrew in compression bandage due to treatment changes required (overwhelming sepsis and ulcer size increase) Participant health‐related quality of life/health status Not reported Cost effectiveness Not reported Mean pain score Not reported Outcomes that are not considered in this review but reported in trials: Reduction in ulcer size presented as the outcome measure. Mean reduction in ulcer size of 67.64% in hydrocolloid dressing and 22.62% in compression bandage (P < 0.0001; SE = 3.51) Participant adherence to compression treatment. This outcome is not measured using a prespecified method. 7 of 36 withdrew in hydrocolloid dressing due to non‐compliance (n = 2) and treatment stopped (n = 5 including 2 having pain and irritation and 3 with overwhelming sepsis); 6 of 36 withdrew in compression bandage due to treatment changes required (overwhelming sepsis and ulcer size increase)
Identification	Publication type/ status (e.g. conference abstract): full paper Trial protocol: not reported Source of funding: not described Country of origin: South Africa Contact information: J.H. Groenewald, Departments of Vascular Surgery, University of Stellenbosch, South Africa
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were selected randomly for treatment either with hydrocolloid dressing or by conventional methods" 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 nature of the dressing made a double‐blind study impractical" Comment: high risk of bias because the authors claimed it is challenging to blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome group: ulcer healing Quote: "... reduction in ulcer size as the main criterion for the evaluation of results. This could be measured fairly accurately by a technician who was not otherwise involved in the trial" Comment: low risk of bias because study authors took measures to reduce the risk of detection bias in measuring ulcer sizes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: no information provided
Selective reporting (reporting bias)	Low risk	Comment: 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