Souliotis 2016.
Methods | A RCT of 100 people with full thickness PUs treated at home Greece Participants recruited from the community and treated in their homes Follow‐up until complete healing |
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Participants |
Inclusion criteria: Stage III or IV PU using the EPUAP classification system) Exclusion criteria:
In the moist wound healing group (n = 47)
In the plain gauze group (n = 48)
Participants were fully informed about the aim of the study and that participation was optional and that they could drop out of the study. All participants signed an informed consent form, and in those cases where they were unable to do so, a designated person signed for them. Participants’ personal data were codified to ensure anonymity and confidentiality. |
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Interventions |
Group A: moist wound dressings (foam dressing with anti‐microbial and analgesic variations) until the wound healed, with no time limit (participants with pressure sores, n = 47) Group B: plain gauze (including gauze soaked in saline) until the wound healed, with no time limit (participants with pressure sores, n = 48) |
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Outcomes |
Primary outcomes Time to complete healing (in days) Adverse events per participant (local wound infection) Secondary outcomes: NR Economic outcomes Cost and incremental cost per event (cost of clinical materials per participant, daily wages and cost of healthcare professionals per home visit) |
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Notes | Only 1 ulcer per person Data collection and ulcer measurements took place once a month until complete healing Costs of dressings and materials informed by the (Greek) Committee for Health Supplies and the average purchase prices paid by public hospitals. Costs per home visit came from official sources regarding public servants’ monthly wages and labour costs Funding source NR |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quotation: "The allocation of the subjects in the group of moist wound dressings and the gauze group was randomised by using sealed opaque envelopes." Comment: not clear how randomisation schedule was devised |
Allocation concealment (selection bias) | Low risk | Quotation: "The allocation of the subjects in the group of moist wound dressings and the gauze group was randomised by using sealed opaque envelopes." Comment: evidence of appropriate randomisation method |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No direct quote addressing this aspect Comment: participants and personnel not blinded to group allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quotation: “Home treatment was performed by healthcare professionals according to the patients’ needs and the ulcer treatment protocols applied by each healthcare service. For the ulcer surface measuring, sterile transparent graded films were used.” Comment: outcome assessment not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quotation: "One patient of the group under treatment with plain gauze and two from the group under treatment with moist wound healing dressings had to be withdrawn from the study. One patient from each group died during the course of the study. The data of the patients who did not complete the study were not included in the data analysis." Comment: a per‐protocol approach which potentially contributed to bias |
Selective reporting (reporting bias) | Unclear risk | No direct quotation addressing this aspect Comment: limited information on which to judge |
Other bias | Low risk | No direct quotation addressing this aspect Comment: none noted |