Romanelli 2015.
| Methods | RCT, parallel; single‐centre trial, participants randomised Setting: outpatients attending wound healing unit. Country: Italy Duration of follow‐up (intervention period): 12 weeks Funding: industry‐funded trial ‐ unrestricted grant from Medskin Solutions (manufacturer of intervention 1) Unit of analysis: participant | |
| Participants | 40 participants with 'hard‐to‐heal' VLUs (non‐responsive ulcers (no measurable improvement after 6 weeks' standard treatment)); participants with venous insufficiency. Number of wounds: not reported. Age: Group 1: mean 68 (SD 5); Group 2: 65 (SD 2). Sex (M/F): Group 1: 7/13; Group 2: 5/15. Duration of ulcer: wound age: Group 1 ‐ mean 24 (SD 6) weeks; Group 2: 20 (SD 4) weeks. Ulcer size: Group 1: mean 26 (SD 4); Group 2: 24 (SD 5) cm². No infected wounds at baseline Inclusion criteria: participants with venous insufficiency and a VLU, which did not respond to 6 weeks' treatment with short‐stretch compression and moist wound healing Exclusion criteria: participants who had diabetes, autoimmune disease or peripheral arterial disease; ABPI < 0.8; participants who smoked or who had VLU(s) with clinical signs of infection | |
| Interventions | Group 1: PMM dressing + basic wound contact dressing + alginate dressing ‐ collagen membrane + non‐adherent petrolatum impregnated dressing + alginate (Proheal® (MedSkin Solutions) + Adaptic® (Systagenix) + Curasorb® (Kendall)): non‐adherent dressing was used as an interface with the secondary dressing; (n = 20; duration 12 weeks) Group 2: alginate dressing ‐ alginate (Curasorb® (Kendall)); (n = 20; duration 12 weeks) Co‐interventions: short‐stretch compression bandaging system Dressing procedure: dressing changes performed twice a week with a saline solution used to cleanse the wound. The collagen dressing was then applied over the wound bed. The short‐stretch compression bandaging system was applied by an experienced nurse and maintained over the lower leg. Prior treatments: all participants had received prior treatment of 6 weeks of compression therapy and moist wound healing. | |
| Outcomes | Primary outcomes of the review: proportion completely healed (12 weeks); adverse events Secondary outcomes: pain (during treatment or at dressing change) | |
| Notes | Group 1 had a non‐adherent dressing as an interface between the collagen membrane and the secondary alginate dressing. Group 2 only had the alginate dressing. We do not consider this to be a substantial difference between interventions, rather a variation on the protease‐modulating dressing. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was established by a random permuted block of five patients, prepared in advance." Comment: Probably computer‐generated |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Randomisation was established by a random permuted block of five patients, prepared in advance." Comment: allocation concealment method unclear |
| Blinding participants and personnel (performance bias) | High risk | Comment: dressings were sufficiently different for participants and personnel to be unblinded ‐ three dressings versus one dressing |
| Blinding outcome assessors (detection bias): healing outcomes | Low risk | Quote: "To improve the quality of this trial and exclude bias during wound assessment, patients were evaluated in a standard room ambient, laying in the same position at each visit. The VLU area was measured with a non‐invasive laser scanning system (Silhouette, Aranz, New Zealand) and by the same two nurses especially trained for this study." Comment: this measurement will have led to the assessment of complete healing. Therefore low risk of bias |
| Blinding outcome assessors (detection bias): adverse events | Unclear risk | Quote: "No significant side effects were detected in either group." Comment: no further information on who assessed the adverse events |
| Blinding outcome assessors (detection bias): secondary outcomes | High risk | Quote: "Patients of both groups were satisfied with their treatment and healing progress, and did not report any problems with pain during treatment or at dressing changes" Comment: participants were the outcome assessors and they would have known whether they had three dressings or one |
| Incomplete outcome data (attrition bias) healing/secondary | Unclear risk | Comment: number of participants with missing data not reported |
| Incomplete outcome data (attrition bias) adverse events | Unclear risk | Comment: number of participants with missing data not reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: pain and adverse events vaguely reported and the number of participants analysed was uncertain. The paper only reported the number randomised per group in the study characteristics table. |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |