Rubin 1990.

Study characteristics
Methods	Study objective: not given Trial design (e.g. parallel group) including research sites: multi‐site, randomised, prospective, blinded trial. Cleveland Ohio Veterans Administration Medical Centre, University Hospitals of Cleveland, and Cleveland Metropolitan General Hospital, USA Follow‐up period: 12 months Number of arms: 2 Study start date and end date: not described Care setting: hospital
Participants	Study population: ambulatory patients with lower‐extremity chronic venous stasis ulceration Eligibilitycriteria: patients with lower‐extremity chronic venous stasis ulceration enrolled; those with history of non‐compliance, presence of significant lower‐extremity arterial insufficiency (as determined by Doppler ABPIs of less than 0.8), history of collagen vascular disease/uncontrolled diabetes/other ongoing dermatological disorders/chronic corticosteroid therapy excluded Sex (M:F): not described Age (years): not described Duration of leg ulcers: not described Baseline leg ulcer area: ranged from 6.0 cm ‐ 270 cm2 (mean 32.2cm2) for Polyurethane Foam Dressing (PFD) group. Ranged from 0.02 – 600 cm2 (mean 76.0 cm2) for Unna Boot group. Students t test P = 0.03 Group difference: ulcers of Unna boot group larger than those of dressing group. Initial bacterial culture results were positive in 13 (76.4%) of 17 limbs from PFD group and 12 (63.1%) of 19 limbs from Unna boot group – not statistically significant Total number of participants: 36 participants Unit of analysis (including number of ulcers per person): participants, and wound healing rates Unit of randomisation (e.g. leg ulcer, limb, or participant): participant
Interventions	Intervention characteristics Polyurethane Foam Dressing Details of interventions (including compression devices used, and duration of interventions applied): Polyurethane Foam Dressing (PFD; Synthaderm Armour Pharmaceutical Co Ltd, East Sussex, UK) is a “synthetic skin” preparation consisting of closed‐cell polyoxyethylene glycol foam separating hydrophobic and hydrophilic surfaces. Applied and removed by the individual hospital‐based nursing personnel. Duration of PFD application not described. Changed weekly or bi‐weekly Descriptions of any co‐interventions or standard care: all wounds were cleansed routinely with skin wound‐cleansing solution (Shur‐Cleans 20% poloxamer). All participants had elastic bandages applied in an identical manner, from the toes to the knees Number of participants randomised: n = 17 participants Number of participants analysed: 17 and 8 participants (9 withdrew) Unna’s boot Details of interventions (including compression devices used, and duration of interventions applied): a gauze bandage impregnated with glycerine, zinc oxide, and calamine lotion. Applied and removed by the individual hospital‐based nursing personnel. Duration of Unna boot application not described. Changed weekly or bi‐weekly Descriptions of any co‐interventions or standard care: all wounds were cleansed routinely with skin wound‐cleansing solution (Shur‐Cleans 20% poloxamer). All participants had elastic bandages applied in an identical manner, from the toes to the knees Number of participants randomised: n = 19 participants Number of participants analysed: 19 participants
Outcomes	Time‐to‐complete wound healing Not reported Proportion of wounds completely healed during follow‐up Outcome type: binary Time points: not described Reporting: partially reported Measurement method (e.g. scale, self‐reporting): not described Definition: complete wound healing Missing data and reasons (including the number of people who died): ITT analysis performed for this outcome; 9 of the 17 in PFD group withdrew prior to 12 months due to wound odour Adverse events Outcome type: binary Time points: not described Measurement method (e.g. scale, self‐reporting): not described Definition: wound complications necessitating hospital admission or cessation of therapy Note: no wound complications necessitating hospital admission of cessation of therapy in either group. 9 of 17 participants in PFD group withdrew due to wound odour 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: Overall wound healing rates (cm2 per day). Withdrawn participants included in analysis. 0.07 cm2/day for PDF group. 0.5 cm2/day for Unna boot group. (P = 0.004, Students t test) Participant compliance with the Unna boot
Identification	Publication type/ status (e.g. conference abstract): full paper Trial protocol: not described Source of funding: not described Country of origin: USA Contact information: Dr Rubin, Department of Surgery, University Hospitals of Cleveland, 2074 Abington Road, Cleveland, OH 44106
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “Each patient was randomised by the study coordinator to either a PFD or Unna boot dressing treatment protocol.” Comment: unclear risk of bias because the method of random‐sequence generation is not specified
Allocation concealment (selection bias)	Unclear risk	Quote: “The study coordinator did not see the randomization card and was therefore blinded as to the treatment cohort” Comment: unclear risk of bias because it is unclear if allocation is concealed so that investigators cannot foresee assignment of participants
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: no information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no information provided on who/how outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome: complete wound healing Quote: “9 (52.9%) of 17 participants of group 1 withdrew from the study due to wound odor” Comment: low risk of bias because although 9/17 participants withdrew before study end from group 1 but no withdrawals from group 2, the authors performed ITT analysis for this outcome
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