Andriessen 2009.
| Methods | RCT, parallel; single‐centre trial, participants randomised Setting: phlebology clinic. Country: Italy Duration of follow‐up (intervention period): 4 weeks Funding: industry‐funded trial ‐ limited grant from Lohmann & Rauscher (manufacturer of both interventions) Unit of analysis: participant | |
| Participants | 12 participants with VLUs (hard‐to‐heal: wounds that had not reduced in size after 4 weeks' standard care). Number of wounds: not reported; if participants had more than one ulcer, the largest was selected (no indication of how many per participant)
Age: mean (range): Group 1: 79 (70‐91); Group 2: 78.25 (70‐81); Group 3: 76.5 (74‐79) years. Sex (M/F): overall: 4/8. Duration of ulcer: mean (median, range): Group 1: 7.75 (9, 4–14); Group 2: 11.25 (14, 4–22); Group 3: 26.25 (11, 4–84) months. Ulcer size: mean (range, assumed): Group 1: 23.97 (12.4–56); Group 2: 27.55 (16–62); Group 3: 17.37 (8.48–29) cm². No infected wounds at baseline Inclusion criteria: transcutaneous oxygen partial pressure measurement of < 40 mmHg; VLU not reduced in size despite 4 weeks of standard care, aged > 18 years Exclusion criteria: clinical signs of infection, necrotic tissue or predominance of slough, significant arterial disease (ABPI < 0.8), ulcers less than 4 cm² or circumferential; other causes of ulceration, oral or topical corticosteroids, participation in a leg ulcer trial in previous year, dementia or disorientation, known allergy for latex/trial products |
|
| Interventions | Group 1: PMM dressing + foam dressing: collagen dressing plus secondary foam dressing (Suprasorb® C (Activa) plus Suprasorb® P (secondary)); (n = 4; duration 4 weeks) Group 2: foam dressing (Suprasorb® P (Lohmann & Rauscher)); i.e. same dressing as secondary dressing for intervention 1 (n = 4; duration 4 weeks) Group 3: basic wound contact dressing ‐ paraffin gauze (manufacturer not stated); (n = 4; duration 4 weeks) Co‐interventions: all participants wore short‐stretch high compression bandages Dressing procedure: the clinician cleansed the VLU with saline and then applied the assigned treatment. Dressing change frequency was at the clinician’s discretion, but on average this took place twice weekly and was based on exudate levels only. Prior treatments: a variety of other modern wound dressings and compression bandaging systems had been used before entry into the study. No participants had previously used the foam or collagen dressings. | |
| Outcomes | Primary outcomes of the review: complete healing not reported; adverse events Secondary outcomes: pain on dressing change (moderate/severe versus little/no pain), change in ulcer size | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised by a computer‐generated allocation scheme." Comment: adequate sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Patients were randomised by a computer‐generated allocation scheme, using sealed envelopes." Comment: partial allocation concealment ‐ envelopes not said to be sequentially numbered or opaque. In addition, there were some baseline differences: in ulcer area (mean 24 versus 28 versus 17 cm²) and duration of ulcer (median 9 versus 14 versus 11 months) |
| Blinding participants and personnel (performance bias) | High risk | Comment: the "clinician" changed the dressings and performed the assessments. Dressings were sufficiently different to be unblinded (2 dressings versus 1 dressing) |
| Blinding outcome assessors (detection bias): healing outcomes | Low risk | Quote: "Assessors were blinded to the treatment given for all of these tests. Ulcer area and wound‐bed characteristics..." Comment: outcome assessors blinded for ulcer area outcome |
| Blinding outcome assessors (detection bias): adverse events | High risk | Comment: the "clinician" changed the dressings and performed the assessments. Dressings were sufficiently different to be unblinded (2 dressings versus 1 dressing for the two comparisons included in this review) |
| Blinding outcome assessors (detection bias): secondary outcomes | High risk | Quote: "Patients reported pain at each dressing removal on a 10cm visual analogue scale (VAS)." Comment: the patient was the outcome assessor. Dressings were sufficiently different to be unblinded (2 dressings versus 1 dressing) |
| Incomplete outcome data (attrition bias) healing/secondary | Low risk | No missing data |
| Incomplete outcome data (attrition bias) adverse events | Low risk | No missing data |
| Selective reporting (reporting bias) | High risk | Comment: paper stated that the "patients who healed before 4 weeks returned to the clinic for a final evaluation", but did not report the number of participants healed. |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |