Wong 2008b.

Study characteristics
Methods	Study objective: to compare the effects in venous leg‐ulcer patients between short‐stretch compression (SSB), 4‐layer compression bandaging (4LB), and usual care with no compression (UC) Trial design (e.g. parallel group) including research sites: parallel, randomised controlled trial, multi‐site Follow‐up period: 6 and 12 weeks Number of arms: 3 Study start date and end date: recruited from August 2004 to March 2006 Care setting: community involving 6 general outpatient clinics located at the Kowloon East Cluster
Participants	Study population: older people with venous ulcer living in the community Eligibilitycriteria: inclusion of either men or women aged 55 years or older having confirmed venous leg ulcers (with partial or full‐thickness skin loss) by clinical and vascular assessment (i.e. Doppler); without necrotic tissue; ability to understand and communicate in Cantonese; ABPI ≥ 0.8 indicating suitability for compression bandaging; have not previously received compression bandage. Exclusion of patients with ulcers > 14cm x 14cm, with an ulcer duration of < 2 months; those with 2 or multiple leg ulcers, with known history of sensitivity to wound dressing or bandage used; with concurrent administration of drugs that may affect ulcer healing, such as corticosteroids or chemotherapeutics, ulcer accompanied with neoplasm skin or tissue infection, and trauma such as burn or surgical incision, diabetic patient receiving oral hypoglycaemic or insulin therapy because reduced pressure is required Sex (M:F): 121:59 overall Age (years): mean 69.3 (SD 9.8) overall Duration of leg ulcers: mean 31.6 (SD 44.8) months overall Baseline leg ulcer area: mean 8.1 (SD 8.8) cm2 overall Group difference: no significant differences between groups in variables explored (e.g. age; sex; ulcer duration; ulcer size) Total number of participants: 180 participants Unit of analysis (including number of ulcers per person): participants, each with 1 ulcer Unit of randomisation (e.g. leg ulcer, limb, or participant): participants
Interventions	Intervention characteristics Four‐layer bandage Details of interventions (including compression devices used, and duration of interventions applied): 4‐layer compression bandaging (Profore; Smith & Nephew PLC, Hull, UK), also described as elastic or long‐stretch compression system, with 5 components: PROFORE WCL (primary dressing), PROFORE#1 (orthopaedic wool), PROFORE#2 (crepe bandage), PROFORE#3 (light compression bandage), PROFORE#4 (cohesive flexible bandage). Typically applied in weekly or bi‐weekly intervals for 12 weeks. The sub‐bandage resting pressure between 40 to 50 mmHg. Descriptions of any co‐interventions or standard care: used along with the usual topical ulcer care, including a moist wound‐healing dressing Number of participants randomised: 60 participants Number of participants analysed: 46 completers Short‐stretch bandage Details of interventions (including compression devices used, and duration of interventions applied): short‐stretch compression system (Rosidal sys; Lohmann & Rauscher GmbH & Co KG, Rengsdorf, Germany), also described as an inelastic compression system, consisting of 2 rolls of high compression, textile‐elastic short‐stretch bandages named as the Rosidal K. It has 5 components: tg tubular bandage, Rosidal soft, Rosidal K, Profix, and Mollelast haft. Typically applied at weekly or bi‐weekly intervals for 12 weeks. The sub‐bandage ankle pressure of 25 ‐ 40 mmHg Descriptions of any co‐interventions or standard care: used along with the usual topical ulcer care, including a moist wound‐healing dressing Number of participants randomised: 60 participants Number of participants analysed: 50 completers Usual care Details of interventions (including compression devices used, and duration of interventions applied): usual care provided by the researcher and 3 clinic nurses, cared provided by the researcher once a week and by clinic nurses for the rest of a week for 12 weeks, treatments including washing, cleansing, and wound dressings. Moist wound healing dressing without compression. Applied alginates, films, foams or absorbent dressings, as well as a bio‐cellulose dressing (Suprasorb A or A+Ag, Suprasorb F, Solvaline, Vliwazell, Suprasorb P, Suprasorb X or X+PHMB; Lohmann & Rauscher GmbH & Co KG, Rengsdorf, Germany) Descriptions of any co‐interventions or standard care: not described Number of participants randomised: 60 participants Number of participants analysed: 54 completers
Outcomes	Time‐to‐complete wound healing Outcome type: time‐to‐event Time points: not relevant Reporting: fully reported Measurement method (e.g. scale, self‐reporting): complete ulcer healing defined according to the criteria of the Wound Healing Society as 100 percent re‐epithelialisation of the wound surface with the absence of exudates Definition: mean time to ulcer healing Missing data and reasons (including the number of people who died): all included in analysis Proportion of wounds completely healed during follow‐up Outcome type: binary Time points: week 6 and 12 Reporting: partially reported Measurement method (e.g. scale, self‐reporting): complete ulcer healing defined according to the criteria of the Wound Healing Society as 100 percent re‐epithelialisation of the wound surface with the absence of exudates Definition: complete ulcer healing Missing data and reasons (including the number of people who died): 30 dropouts including 10 for SSB, 14 for 4LB, and 6 for control Adverse events Outcome type: binary Time points: not described Measurement method (e.g. scale, self‐reporting): probably not measured using a prespecified method Definition: total numbers of participants with adverse events Notes: the study authors reported hospitalisation due to medical conditions as a reason of withdrawals but did not consider it as adverse events (see Table 22 of Wong 2008b). The review authors did not extract relevant data here. Participant health‐related quality of life/health status Outcome type: continuous Time points: week 6 and 12 Reporting: partially reported Measurement method (e.g. scale, self‐reporting): Chinese (Hong Kong) Short Form‐12‐item Health Survey (SF‐12) as a generic QOL tool (a higher scoring = a better quality of life); Charing Cross Venous Ulcer Questionnaire (Chinese) as a disease‐specific QOL measurement instrument (lower scores = better quality of life); all collected at weeks 12. Definition (including ulcer stage): health‐related quality of life Missing data and reasons (including the number of people who died): 30 dropouts including 10 for SSB, 14 for 4LB, and 6 for control Notes: outcome assessor unspecified. Cost effectiveness Not reported Mean pain score Outcome type: continuous Time points: week 6 and 12 Reporting: fully reported Measurement method (e.g. scale, self‐reporting): self‐rated using Brief Pain Inventory instrument with a 10‐point VAS scale with grades from 0 to 10; 0 = least painful. Collected at 12 weeks Definition (including ulcer stage): ulcer‐related pain severity Missing data and reasons (including the number of people who died): 30 dropouts including 10 for SSB, 14 for 4LB, and 6 for control Notes: outcome assessor unspecified. Pain interference with various aspects of QOL measured but not extracted for this review. Outcomes that are not considered in this review but reported in trials: The average ulcer area Pain interference with various aspects of QOL Interface pressure Frenchay Activities Index for lifestyle activity
Identification	Publication type/ status (e.g. conference abstract): PhD thesis (Wong 2008b) Trial protocol: not described Source of funding: funded by the Special Grant for Conducting Research Aboard, the Chinese University of Hong Kong (2004) Country of origin: Hong Kong Comments: the trial has a pilot study Wong 2008a Contact information: Irene KY Wong
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Eligible patients were randomly assigned to either one of the experimental groups or the control group by a random list ... A randomisation list with three treatment blocks was generated by a computer program before the study ...” Comment: low risk of bias because of the use of a proper method of generating random sequence.
Allocation concealment (selection bias)	Unclear risk	Quote: “The participants were allowed to open the envelope for grouping allocation only after the collection of baseline data. The patients were not informed whether they were assigned to an intervention or control group until the completion of the study. The strength of this allocation concealment in random trials ...” Comment: unclear risk of bias because information provided is insufficient for this domain’s judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Outcome group: all outcomes Quote: "participants and interviewers (data collectors) were not informed of the treatment allocation of the study participants for the duration of the study" Quote: "the interveners who performed wound dressing and/or bandaging were not blinded to the treatment groups. Blinding the interveners is not achievable ..." Comment: high risk of bias
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome group: ulcer healing and pain outcomes Quote: "This was a double‐blind study, in which the interviewers who were responsible for the pre‐test and post test data collections were not given any information regarding the group to which the participant was assigned" Quote: "The data collector then received the electronic file periodically and performed the perimeter tracing and area calculation using the Wound Measurement System software. As a result, the data collector assessed the ulcer size without seeing the participant ..." Comment: low risk of bias.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome group: time to healing Quote: “... only analyse the data of those participants who had received the treatment ... an intention to treat analysis was adopted during the process of survival analysis only” Comment: low risk of bias because of the use of ITT analysis. Outcome group: all other outcomes including healing incidence Comment: high risk of bias because despite a moderate rate of attrition (30/180, 16.7%) the excluded cases had larger ulcer sizes than those completed
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