Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing · 2025
Comparison of 'Lite' reduced compression two-layer bandages for treatment of leg ulcers: Results of the pragmatic, single-centre randomized controlled PEACH trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеPragmatic Clinical TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Todhunter Jane, Greenhow Helen, Jonker Leon
Аннотация
BACKGROUND: In a subset of patients with leg ulcer, reduced compression is indicated to aid wound healing whilst not compromising circulation. It is not clear if there are differences in efficacy between different two-layer compression bandages.
METHODS: A single-centre, prospective, non-blinded, randomised, controlled trial was conducted in a Hospital's vascular department in England to determine 'wound healed' status at week 12 of treatment. Two 'Lite' compression bandaged were compared, each providing ∼25 mmHg of pressure. Eligible patients could have leg ulcer of venous or mixed venous-arterial nature, with or without contributing co-morbidities.
RESULTS: In total, 78 patients were randomised. With Andoflex TLC Calamine Lite (also marketed under brand name Coflex, OVIK Health) 18 out of 34 (53%) wounds healed and for Coban2 Lite (3 M) this figure was 15 out of 33 (45%; p-value 0.63, Fisher exact test). A secondary outcome semi-quantitative measure of wound size, PUSH score, did not show a statistical difference between the two bandages either: median score of 0 (inter-quartile range 7) for Andoflex TLC Calamine Lite and 1.5 (inter-quartile range 8) for Coban2 Lite respectively (p-value 0.60, Mann-Whitney U test). Associated leg ulcer symptoms did not differ significantly either.
CONCLUSIONS: Andoflex TLC Calamine Lite and Coban2 Lite are non-inferior to each other to up to 20% difference in 'wound healed' status at twelve weeks of compression bandage treatment. Any preference in utilisation of one over the other can therefore be dictated by clinician and patient preference. Future research may focus on a comparison of two-layer compression in patients who can tolerate full compression, and/or of two-layer versus hosiery or four-layer devices.
METHODS: A single-centre, prospective, non-blinded, randomised, controlled trial was conducted in a Hospital's vascular department in England to determine 'wound healed' status at week 12 of treatment. Two 'Lite' compression bandaged were compared, each providing ∼25 mmHg of pressure. Eligible patients could have leg ulcer of venous or mixed venous-arterial nature, with or without contributing co-morbidities.
RESULTS: In total, 78 patients were randomised. With Andoflex TLC Calamine Lite (also marketed under brand name Coflex, OVIK Health) 18 out of 34 (53%) wounds healed and for Coban2 Lite (3 M) this figure was 15 out of 33 (45%; p-value 0.63, Fisher exact test). A secondary outcome semi-quantitative measure of wound size, PUSH score, did not show a statistical difference between the two bandages either: median score of 0 (inter-quartile range 7) for Andoflex TLC Calamine Lite and 1.5 (inter-quartile range 8) for Coban2 Lite respectively (p-value 0.60, Mann-Whitney U test). Associated leg ulcer symptoms did not differ significantly either.
CONCLUSIONS: Andoflex TLC Calamine Lite and Coban2 Lite are non-inferior to each other to up to 20% difference in 'wound healed' status at twelve weeks of compression bandage treatment. Any preference in utilisation of one over the other can therefore be dictated by clinician and patient preference. Future research may focus on a comparison of two-layer compression in patients who can tolerate full compression, and/or of two-layer versus hosiery or four-layer devices.