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. 2022 Aug 5;2022(8):CD010738. doi: 10.1002/14651858.CD010738.pub2

De la Brassinne 2006.

Study characteristics
Methods Design: open; RCT
Country: Belgium
Setting: hospital
Sample size calculation: not reported
Ethical approval: was granted after the medical ethics committee approved the project (Ethics Committee of the Medicine Faculty of Liege University, Belgium).
Informed consent: was obtained after fully advising the participants about the purpose and consequences of the study.
Participants Total sample: 20 hospitalised participants with chronic leg ulcers of venous origin
Inclusion criteria: men and women, mobile, aged 40–70 years and chronic leg ulcers of venous origin with exudate
Exclusion criteria: none specified
Numbers randomised
  • Group 1 (hydrogel dressing): 10 participants

  • Group 2 (alginate dressing): 10 participants


Gender: 13 women and 7 men
Mean age: 61 years (range 45–70 years)
ABPI: not reported
Unit of randomisation: participant
Unit of analysis: participant
Ulcer infection: not reported
Ulcer duration (current): 2.25 years (range 0.5–10 years) in both groups
Baseline ulcer surface
  • Group 1 (hydrogel dressing): 20.9 (SD 7.5) cm²

  • Group 2 (alginate dressing): 20.3 (SD 7.6) cm² (P = 0.826)


Baseline volume measurement
  • Group 1 (hydrogel dressing): 128.4 (SD 55.2) mm³

  • Group 2 (alginate dressing): 124.7 (SD 49.9) mm³


Data collected: ulcer dimension by planimetry and volume of the ulcer at day 7, 14 and 28
Interventions Group 1: hydrogel dressing (IntraSite Gel)
Group 2: alginate dressing (Flaminal gel)
*Both groups had the wound debrided and cleaning with saline before the dressing was applied.
Description of compression therapy: not reported
Length of treatment: 4 weeks
Follow‐up: 4 weeks
Comments:
* The surface measurement of the ulcer was made using acetate tracing (Opsite Flexigrid from Smith & Nephew Healthcare).
* The volume measurement of the ulcer was made using high algin impression material (Jeltrate mould from Dentsply Caulk International)
Outcomes Complete wound healing: not reported
Incidence of wound infection: not reported
Change in ulcer size: reported, planimetry used to measure the wound at baseline, 7, 14 and 28 days of treatment and volume measured on same days
Mean percentage surface reduction at day 14 (P < 0.01)
  • Group 1 (hydrogel dressing): –3.2% (SD 13.3%)

  • Group 2 (alginate dressing): –27.3% (SD 20.6%)


Mean percentage surface reduction at day 28 (P ≤ 0.01)
  • Group 1 (hydrogel dressing): –19.4% (SD 24.3%)

  • Group 2 (alginate dressing): –61.2% (SD 26.2%)


Time to ulcer healing: not reported
Recurrence of ulcer: not reported
Health‐related quality of life: not reported
Pain: not reported
Costs: not reported
 
Notes Number of participants withdrawing and reasons: no withdrawals
Funding: UCB‐Belgium
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The study was performed in two‐armed parallel groups, open and randomised".
Comment: no further description of method of randomisation provided.
Allocation concealment (selection bias) Unclear risk Comment: no mention of allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: open study.
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: open study.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: the study started with 20 participants and the authors did not report dropouts. All the participants were included in final analysis.
Selective reporting (reporting bias) Low risk Comment: all trial outcomes described in the methods section of the report were included in the results section. Unable to obtain RCT protocol (no response to email sent to trial author).
Other bias Low risk Comment: there was no report regarding the balance between men and women allocated on each group; however, the baseline ulcer surface area and volume did not differ between groups.