Abstract
Objective:
To compare a new ‘advanced’ hydrocellular Polyurethane dressing (HPD) (Allevyn) with a traditional simple non-adherent knitted viscose dressing (KDV) (Tricotex) in the treatment of chronic venous leg ulcers.
Design:
A randomized trial of factorial design, with interaction testing, to allow the evaluation of two different therapeutic components (dressing and bandages) within a single trial. The treatment period was 12 weeks or until healing, whichever occurred sooner.
Setting:
The Leg Ulcer Clinics of Edinburgh and Falkirk and District Royal Infirmaries, Scotland.
Patients:
132 patients with chronic venous leg ulcers were randomized, 66 to HPD and 66 to KVD. Principal exclusions were patients with diabetes, rheumatoid disease or Doppler ankle/brachial pressure indices of less than 0.8. There were 28 withdrawals (15 KVD, 13 HPD). These were considered as treatment failures.
Interventions:
Dressings and bandaging were applied by specialist leg ulcer nurses using standard techniques throughout, the bandaging being randomized to either elastic or non-elastic multilayer systems.
Main outcome measure:
The principal end-point was ulcer healing. Also monitored were healing rates, pain and the frequency of dressing changes.
Results:
Pain relief was significantly better in the HPD group (p=0.01). Thirty-one (47%) of the HPD patients healed within 12 weeks compared with only 23 (35%) of the those treated with KVD (95% confidence limits for difference, −5% to +29%). The higest healing rates (61% for all ulcers and 74% for those less than 10 cm2) were observed in the subgroup in which HPD was used in combination with an elastic bandaging system.
Conclusion:
Patients treated with HPD did significantly better in terms of pain relief, although the higher healing rates observed in this group failed to reach significance at the 5% level.
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