Meaume 2003.

Methods	A multi‐centre, open, RCT with 38 participants Conducted in 3 European countries Follow‐up: 8 weeks Participants recruited from 3 nursing homes in Belgium, France and Italy. No other specific details provided
Participants	Inclusion criteria: participants ≥ 65 years, Stage II PU as per EPUAP which had not improved in the preceding 4 weeks, a Modified Norton Scale Score ≥ 11, red/yellow wound according to the Red‐Yellow‐Black System Exclusion criteria: underlying disease that may interfere with the treatment of the PU, food and/or fluid intake score of ≤ 2 on the Modified Norton Scale, allergic/hypersensitivity to any material in the dressings, a wound larger than 11 cm x 11 cm, a wound with black necrotic tissue or clinical signs of local infection at baseline In the silicone foam dressing group at baseline (n = 18): age (years): mean 83.8, range 74.9‐95.1 gender: female (n = 16), male (n = 2) location of PUs: heel (n = 5), foot (n = 2), leg (n = 1), sacrum (n = 3), back/other (n = 3) and ischium (n = 2) appearance of ulcer: granulation ( n = 13), epithelialisation (n = 10), exudate (n= 13), maceration (n = 6) duration of ulcer (weeks): mean 8.3, range 1‐24 dressing changes prior to enrolment into the study (per week): 3.6, range 1‐7 history of surgical intervention (n = 7) wound size (cm2): mean 4.9, range 0.7‐25.3 Use of other PU prevention devices: pressure relieving mattress (n = 11) and other devices such as position changes or pressure relieving boots (n = 3) In the hydropolymer foam dressing group at baseline (n = 20): age (years): mean 82.5, range 66.4‐91.9 gender: female (n = 16), male (n = 4) location of PUs: heel (n = 4), foot (n = 2), leg (n = 4), sacrum (n = 6), back/other (n = 2), ischium (n = 1) and elbow (n = 1) appearance of ulcer: granulation (n =19), epithelialisation (n = 12), exudate (n= 17), maceration (n = 2), leakage (n = 1) duration of ulcer (weeks): mean 13, range 1‐52 dressing changes prior to enrolment into the study (per week): 3.5, range 1‐7 history of surgical intervention (n = 5) wound size (cm2): mean 4.9, range 0.7‐25.3 Use of other PU prevention devices: pressure relieving mattress (n = 16) and other devices such as position changes or pressure relieving boots (n = 16) Study performed in accordance with ethical principals outlined in the Declaration of Helsinki and informed, written consent obtained from all participants
Interventions	Group A: silicone foam dressing (Mepilex Border by Molnlycke) until the wound healed, or for a maximum of 8 weeks (n = 18) Group B: hydropolymer foam dressing (Tielle by Johnson & Johnson) until the wound healed, or for a maximum of 8 weeks (n = 20)
Outcomes	Primary outcomes Incidence of healed PUs Adverse events Secondary outcomes Reduction in ulcer size Economic outcomes: NR
Notes	Only 1 PU per participant Adverse events per participant Silicone foam dressing group: 4 participants reported adverse events; three were unrelated to the study dressing (1 participant in poor general health died, one suffered a hip fracture, and one has a PU that deteriorated to a Stage IV PU. 1 participant had hypergranulation tissue formation, which could be classified as an adverse device event Hydropolymer dressing group: 6 participants had adverse events; four were due to the device (hypergranulation tissue formation, new wounds, redness and irritation, 1 participant died of broncho‐pneumonia, and 1 participant developed symptoms of heart disease Funding source: NR
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quotation: "Participants were randomly assigned to one of the two treatment options by a predetermined computer‐generate randomisation list stratified by study centre, and the block size was unknown to the investigators. Each centre received numbered, sealed envelopes to be opened in consecutive order.” Comment: evidence of appropriate randomisation method
Allocation concealment (selection bias)	Low risk	Quotation: "Participants were randomly assigned to one of the two treatment options by a predetermined computer‐generate randomisation list stratified by study centre, and the block size was unknown to the investigators. Each centre received numbered, sealed envelopes to be opened in consecutive order.” Comment: evidence of appropriate randomisation method
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quotation: “The study was not blinded because dressing differences make blinding difficult to achieve.” Comment: participants and personnel were not blinded to group allocation
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quotation: “The study was not blinded because dressing differences make blinding difficult to achieve.” Comment: outcome assessment not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No direct quotation addressing this aspect Comment: data appear to be presented for all participants
Selective reporting (reporting bias)	Low risk	Quotation: “The results of this exploratory study indicate that the soft silicone dressing is superior to dressings using traditional adhesive technologies. These findings need to be confirmed in other controlled studies” Comment: acknowledged to be an exploratory study. Data appear to be presented for all participants.
Other bias	Low risk	Quotation: “Patients were excluded from this study if they suffered from an underlying disease that, according to the investigator, might possibly interfere with the treatment of the pressure ulcer” Comment: limited information on which to judge