Taddeucci 2004.

Study characteristics
Methods	Research design: open, single‐centre, randomised, parallel, comparative study Care setting: outpatients Country of origin: Italy Publication source:Journal of Wound Care Year of publication: 2004 Duration of follow‐up: 8 weeks or until the ulcer healed, whichever occurred first Sources of funding: none Unit of randomisation: participant Unit of analysis: ulcer Inclusion criteria: consenting patients aged over 18 years; venous ulceration present for at least 3 months Exclusion criteria: arterial, metabolic, or traumatic ulcers; infected ulcers with signs of cellulitis; immunosuppressive, corticosteroid, or cytostatic therapy within 4 weeks prior to study enrolment; insulin‐dependent diabetes; concomitant diseases such as tumours or metabolic diseases; pregnancy or suspected pregnancy
Participants	Number of participants: 17 participants with 24 ulcers (group 1: 12 ulcers; group 2: 12 ulcers) Male gender: not described Age: not described
Interventions	Details of the intervention Group 1: Hyaluronic acid (Hyalofill‐F, a hyaluronan derivative) covered with sterile gauze and the compression bandage Pehacrepp E Group 2: paraffin gauze (control treatment; standard therapy in Italy) covered with sterile gauze and the same compression bandage Dressing procedure: during the assessment visits the investigator cleansed the ulcer with sterile saline, applied the treatment dressing and then the compression Co‐interventions: followed by compression bandaging Duration of treatment: 8 weeks or until the ulcer healed, whichever occurred first
Outcomes	Primary outcomes of the review: complete wound healing Secondary outcomes: change in wound size, pain
Notes	Losses to follow‐up: 6 participants (group 1: n = 1; group 2: n = 5)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The authors report the randomisation, however they do not make clear the method used. There is a reference to "... assigned sequentially to one of two treatments:", however we are not sure if this is a referring to a pre‐determined sequence or if they used alternation (which would not be a true randomisation method). We were not able to obtain the answer to this question and the trial was maintained in the review.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study
Incomplete outcome data (attrition bias) All outcomes	High risk	High percentage of losses (25%) in the study (withdrawn reported based on ulcers, not subjects). Not clear how many volunteers dropped‐out.
Selective reporting (reporting bias)	Low risk	All proposed outcomes described in methods section are presented and properly analysed.
Other bias	High risk	Data analysis was based on number of ulcers that exceed the number of randomised participants. Baseline characteristics of volunteers in each group was not reported.

ABPI: Ankle‐Brachial Pressure Index; ASAT/ALAT: aspartate amino transferase/alanine amino transferase ratio; DFU: diabetic foot ulcer; HA: hyaluronic acid; HC: hydrocolloid; IMD: investigational medical devices; ITT: intention‐to‐treat; PRGF: platelet‐rich plasma growth factor; RCT: randomised controlled trial; ULN: upper limit of normal; VAS: visual analogue scale