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 |
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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):
In the hydrogel dressing group at baseline (n = 17, with 20 ulcers):
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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) |
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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 |
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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 |
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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 |