Kikta 1988.

Study characteristics
Methods	Study objective: not given Trial design (e.g. parallel group) including research sites: parallel, randomised controlled trial, multi‐site (University of Illinois Hospital, Westside Veterans Administration Hospital, and Cook County Hospital Vascular Surgery Clinics, USA) Follow‐up period: 6 months Number of arms: 2 Study start date and end date: not described (randomisation between February 1986 and January 1987) Care setting: hospital (clinics)
Participants	Study population: leg ulcers caused by chronic venous insufficiency Eligibilitycriteria: included people with leg ulcers caused by chronic venous insufficiency. Excluded those with the presence of arterial insufficiency as measured by Doppler‐derived ABPI of less than 0.7, uncontrolled diabetes mellitus, the use of cancer chemotherapeutic agents or systemic steroids, recent venous surgery, infected ulcers, and inability to comply with treatment or follow‐up Sex (M:F): not described Age (years): not described Duration of leg ulcers: mean 45 (SEM 12) weeks in hydroactive dressing (number of ulcers unspecified (n = 39 ulcers)); 51 (17) in Unna’s boot (number of ulcers unspecified (n = 30 ulcers)), Student’s t test P‐value = 0.77 Baseline leg ulcer area: mean 8.6 (SEM 2.1) cm2 in hydroactive dressing (number of ulcers unspecified (n = 39 ulcers)); 9.0 (2.2) in Unna’s boot (number of ulcers unspecified (n = 30 ulcers)), Student’s t test P‐value = 0.88 Group difference: no statistically significant differences between groups in many variables (e.g. age; sex; race; type of previous ulcer treatment; pre‐randomisation use of antibiotics; origin of chronic venous insufficiency; the incidence of previous venous, arterial, or orthopaedic operations; prior use of elastic stockings; the incidence of ischaemic heart disease, congestive heart failure, diabetes mellitus, hypertension, pulmonary, renal, and hepatic diseases; the use of oral contraceptives or tobacco; the presence of obesity or alcoholism; elevated levels of serum haemoglobin, glucose, albumin, and creatinine; whether the ulcer was new or recurrent; ABIs; and PPG‐VRT) Total number of participants: 84 participants with 87 ulcers Unit of analysis (including number of ulcers per person): ulcers, approximately 1 ulcer per person Unit of randomisation (e.g. leg ulcer, limb, or participant): participants
Interventions	Intervention characteristics Unna’s boot Details of interventions (including compression devices used, and duration of interventions applied): this compression therapy is a moist paste bandage impregnated with zinc oxide, calamine lotion, and glycerine, wrapped snugly about the entire leg in direct contact with the ulcer, worn continuously, and changed weekly. Duration of Unna’s boot applied unspecified Descriptions of any co‐interventions or standard care: all participants received instruction on leg elevation, restriction of standing activities, care for associated medical problems, and the importance of compliance and follow‐up. At each clinic visit, ulcers were washed with dilute chlorhexidine solution followed by 3% hydrogen peroxide, rinsed with normal saline solution, and allowed to air‐dry Number of participants randomised: number of participants unknown, 42 ulcers Number of participants analysed: 30 ulcers Hydroactive dressing Details of interventions (including compression devices used, and duration of interventions applied): DuoDERM (Convatec‐Squibb, Princeton, N. J.) hydroactive dressing (HD) is an occlusive, virtually oxygen‐impermeable, wafer‐like sheet of hydrophilic particles encased in an inert hydrophobic polymer matrix placed on an adhesive plastic backing. Compression was not applied in HD. HD is replaced at least once a week. Duration of HD applied unspecified Descriptions of any co‐interventions or standard care: all participants received instruction on leg elevation, restriction of standing activities, care for associated medical problems, and the importance of compliance and follow‐up. At each clinic visit, ulcers were washed with dilute chlorhexidine solution followed by 3% hydrogen peroxide, rinsed with normal saline solution, and allowed to air‐dry Number of participants randomised: number of participants unknown, 45 ulcers Number of participants analysed: 39 ulcers
Outcomes	Time‐to‐complete wound healing Outcome type: time‐to‐event Time points: not relevant Reporting: partially reported Measurement method (e.g. scale, self‐reporting): not described Definition: mean time to ulcer healing Missing data and reasons (including the number of people who died): 6 of 45 dropouts in hydroactive dressing and 12 of 42 in Unna’s boot. No reason given 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: ulcer healing within 6 months Missing data and reasons (including the number of people who died): 6 of 45 dropouts in hydroactive dressing and 12 of 42 in Unna’s boot Adverse events Outcome type: binary Time points: not described Measurement method (e.g. scale, self‐reporting): not described Definition: total numbers of ulcers with complications requiring cessation of therapy within 6 months Participant health‐related quality of life/health status Not reported Cost effectiveness Not reported Notes: weekly costs of therapy per participant mean USD 14.24 (SEM 1.63) in hydroactive dressings; USD 11.76 (0.56) in Unna’s boot; Student’s t test P‐value 0.16 Mean pain score Outcome type: continuous Time points: not reported Reporting: partially reported Measurement method (e.g. scale, self‐reporting): participants self‐rated using a linear scale with grades from 1 to 10; 1 = least painful Definition (including ulcer stage): evaluating dressing in terms of pain Missing data and reasons (including the number of people who died): not reported Outcomes that are not considered in this review but reported in trials: Proportion of wounds completely healed or improved during follow‐up Participants self‐reported convenience of using either intervention (rated using a linear scale with grades from 1 to 10; 1 = most convenient) Participants self‐reported ease of change (rated using a linear scale with grades from 1 to 10; 1 = easiest to change)
Identification	Publication type/ status (e.g. conference abstract): full paper Trial protocol: not described Source of funding: not described Country of origin: USA Comments: this study was presented at the combined breakfast program of the Society for Vascular Surgery and the International Society for Cardlovascular Surgery, North American Chapter, Toronto, Ontario, Canada, 09 June 1987. However, the abstract is not available Contact information: D. Preston Flanigan, M.D., Chief, Division of Vascular Surgery (m/c 957), University of Illinois at Chicago, 1740 West Taylor St., Suite 2200, Chicago, IL 60612
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “... patients with leg ulcers caused by chronic venous insufficiency were randomised to receive local wound care with either UB or HD ...” Comment: unclear risk of bias because the method of random sequence generation is not specified
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided
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 Outcomes: pain Comment: high risk of bias because this outcome is self‐rated by participants
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: “Eighteen patients withdrew from study participation within 2 weeks of randomization, leaving 69 ulcers in 66 patients available for analysis” Quote: “There was no statistically significant difference (p = 0.11, FET) between the number withdrawing from the HD group (6 of 45) and the UB group (12 of 42) ... Despite the greater withdrawal rate from the UB group, there was still a statistically significant difference in healing rates (p = 0.01, log rank test) between ...” Outcome: proportion of wounds completely healed Comment: low risk of bias because despite a high proportion of dropouts, results are consistent between life‐table analysis that incorporates dropouts, and Chi2 test that excludes dropouts Outcome: pain Comment: high risk of bias because dropout rate is higher in Unna’s boot group than hydroactive dressing group and pain could be one of likely reasons why dropouts occur Outcome: other outcomes Comment: unclear risk of bias.
Selective reporting (reporting bias)	High risk	Comment: high risk of bias because participant compliance seems prespecified but its results are not presented
Other bias	High risk	Comment: high risk of bias because the unit of randomisation was participants but the unit of analysis was probably leg ulcers