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
Participants	Inclusion criteria: Stage III or IV PU using the EPUAP classification system) Exclusion criteria: < 18 years old end stage chronic heart disease renal disease chronic obstructive pulmonary disease dependent diabetes cancer serious immunodeficiency severe systematic infection previous ulcer treatment with a different method In the moist wound healing group (n = 47) included foam dressings, silver foam dressings, silver‐sulfadiazine dressings and ibuprofen‐releasing foam dressings age (years): mean 75.5, SD 8.6 gender: female (n = 20), male (n = 27) location of PUs: coccyx (n = 18), buttocks (n = 8), trochanters (n = 12), heels (n = 7), other (n = 2) initial ulcer surface in cm2: mean 43.5, SD 30.7 total number treatment days until healing: 4278 average number treatment days until healing: mean 85.6, SD 52.1 total dressing change until healing: 2475 average dressing change until healing: mean 49.5, SD 29.6 local infection in 12 cases x 8 participants ‐ 4 showing 1 case of infection during treatment and 4 showing 2 cases In the plain gauze group (n = 48) included plain sterile gauzes or saline‐moistened gauzes held in place with adhesive tape age (years): mean 77.2, SD 8.02 gender: female (n = 23), male (n‐ 25) location of PUs: coccyx (n = 16), buttocks (n = 6), trochanters (n = 13), heels (n = 10), other (n = 3) initial ulcer surface in cm2: mean 41.52, SD 29.4 total number treatment days until healing: 6070 average number treatment days until healing: mean 121.4, SD 52.2 total dressing change until healing: 11,130 average dressing change until healing: mean 222.6, SD 101.9 local infection in 21 cases x 14 participants ‐ 9 showing 1 case of infection during treatment and 6 showing 2 cases 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.
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)
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)
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
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