Sopata 2002.

Methods	A single‐centre prospective, RCT with 34 participants with advanced cancer Conducted in Poland Follow‐up: 8 weeks Participants recruited over 3 years from January 1996‐January 1999 in a palliative care department
Participants	Inclusion criteria: advanced cancer and a life expectancy of > 8 weeks, Grade II or III PUs (using the Torrance 5‐stage classification system) Exclusion criteria: poor general condition, with low levels of haemoglobin and albumin and use of drugs such as corticosteroids that could affect wound healing In the polyurethane foam dressing group at baseline (n = 17, with 18 ulcers): age (years): mean 58.5, SD 16.92 gender: female (n = 10), male (n = 7) stage of PU: Stage/Grade II (n = 6), Stage/Grade III (n = 12) duration of ulcer (weeks): mean 2.46, SD 0.24 wound size (cm2): mean 11.04, SD 11.65 location of PUs: NR In the hydrogel dressing group at baseline (n = 17, with 20 ulcers): age (years): mean 58.7 SD 14.11 gender: female (n = 8), male (n = 9) stage of PU: Stage/Grade II (n = 6), Stage/Grade III (n = 14) duration of ulcer (weeks): mean 2.45, SD 1.60 wound size (cm2): mean 8.28, SD 13.90 location of PUs: not reported
Interventions	Group A: polyurethane dressing (Lyofoam) until the wound healed, or for a maximum of 8 weeks (n = 17, with 18 ulcers) Group B: hydrogel dressing (Aquagel) until the wound healed, or for a maximum of 8 weeks (n = 17, with 20 ulcers)
Outcomes	Primary outcomes Note: primary outcomes reported in this study were different to a priori criteria reported in the review protocol Incidence of healed PUs Time to complete healing (in days) Adverse events per participant Secondary outcomes Reduction in ulcer size Economic outcomes: NR
Notes	A primary outcome of this review was to measure the incidence of healed PUs with respect to the unit of analysis being the proportion of participants in whom a PU healed. There is limited information to extrapolate this information from the analysis presented Ethical approval for the study and informed consent for participants NR Funding source NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quotation: "Patients were randomly allocated, using a computer number system, to treatment with either Lyofoam or Aquagel." Comment: not clear how randomisation schedule was devised or implemented
Allocation concealment (selection bias)	Unclear risk	Quotation: "Patients were randomly allocated, using a computer number system, to treatment with either Lyofoam or Aquagel." Comment: not clear if allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quotation: “All patients were treated by the main researcher (M. Sopata) or by one of two departmental nurses.” Comment: not clear if some participants and personnel were blinded to group allocation
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quotation: “All patients were treated by the main researcher (M. Sopata) or by one of two departmental nurses.” Comment: outcome assessment not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quotation: “In the Lyofoam group, six (100%) Grade II and nine (75%) Grade II ulcers healed. Three Grade III ulcers improved although two of these belonged to patients who died before the end of the study and one did not heal. In the Aqucel group, six (100%) Grade II and nine 64%) Grade III ulcers healed. Four patients had four wounds that improved (29%) but, again, these wounds belonged to three patients who does before the end of the study and one did not heal. The treatment failed in one ulcer.” Comment: ITT analysis assumed suggesting complete reporting of outcome data
Selective reporting (reporting bias)	Low risk	No direct quotation addressing this aspect Comment: outcome measures reported in methods section were reported in the results section
Other bias	Low risk	No direct quotation addressing this aspect Comment: none noted