A randomised controlled 8‐week crossover clinical evaluation of the 3M™ Coban™ 2 Layer Compression System versus Profore™ to evaluate the product performance in patients with venous leg ulcers

Abstract

This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL.

The financial and quality‐of‐life cost to patients living with a chronic wound in the community

“…Our study found sub‐optimal health‐related quality of life, the CWIS global rating and satisfaction with this rating, 6 of 10 on average. This finding is not dissimilar to baseline scores reported in other research . Our sample reported higher scores for all sub‐scales of the CWIS than people who have gout‐related foot wounds and slightly higher physical symptom and daily living scores than people with lower leg ulcers .…”

3M Coban 2 Layer Compression Therapy: Intelligent Compression Dynamics to Suit Different Patient Needs

“…The study was not powered to detect differences in wound healing. 8 patients with ankle-brachial pressure indexes between 0.5 and 0.8. The product was safe and well tolerated, and results of laser Doppler flowmetry indicated significant improvements of the dermal capillary system After each application, a 10-cm long line was marked on the applied bandage.…”

Therapie des Ulcus cruris venosum

“…Unter diesen Verbänden ist die Zeit bis zur Abheilung 30% kürzer als unter klassischen Kurzzugbandagen[14]. Während die ersten Vertreter dieser Ver bandsysteme aus Kurz und Langzugbin den bestanden, entfielen die Langzugbin den -ohne Wirksamkeitseinbußen -in den neueren Systemen[10].Ein gewisser Nachteil dieser Verbände ist, dass sie relativ dick auftragen und nor males Schuhwerk von dem Patienten oft nicht getragen werden kann. Diese Ver bände sollten daher vornehmlich in der Entstauungsphase Verwendung finden.…”