Multicentre, randomised controlled trial of four-layer bandaging versus short-stretch bandaging in the treatment of venous leg ulcers

Background: Aim of the study was to compare the healing rates of venous ulc ers obtained,with four-layer bandages (4LB) versus short stretch bandages ( SSB). Design: Multicentre, randomised controlled trial performed in 5 centres of the Netherlands and in 2 centres in Austria ("PADS-study" = Profore (TM) Au strian Dutch Study). Patients and methods: 112 patients (53 treated,with 4LB and 59 treated with SSB) completed at least one post-treatment follow-up, 90 completed the stu dy. Bandaging and ulcer assessment was performed at weekly intervals. Rando misation was carried out for each centre and was stratified according to th e size (more or less than 10 cm(2)) of the ulcerated area. Local therapy co nsisted of plain absorbing, non-adherent dressings. Time to complete healin g M,as recorded lip to a maximum of 16 weeks. The two treatment-groups were comparable regarding their baseline-characteristics. Results: In total 33/53 (62%) of ulcer-patients were healed in the 4LB grou p, compared with 43/59 (73%) in the SSB group (difference 11%, 95% CI -28% to 7%). 77% of the ulcers with an initial area less than 5 cm2 healed as co mpared with 33% of the larger ulcers. The different healing rates in the ce ntres could be explained by the different sizes of the treated ulcers. Base d on Kaplan-Meier estimates the median healing time was 57 days for the 4LB (95% C147-85 days) and 63 days for the SSB (95% CI 43-70 days). Conclusion: The ulcer healing rate and the median healing time did not diff er among the two types of bandages. The main discriminant criterion for hea ling was the initial ulcer size. In centres who are experienced users of sh ort-stretch bandages, no statistically significant different healing rates of venous ulcers could be found after 4LB or SSB.