A dual compression system: preliminary clinical insights from the US

Abstract

There is growing evidence on an interconnection between the venous and lymphatic systems in venous leg ulceration, and the possible effects of prolonged oedema and lymphatic impairment in delayed wound healing. Compression therapy is a widely accepted treatment for venous and lymphatic disorders, as it decreases recurrence rates and prolongs the interval between recurrences. Compression bandages improve venous return, increase the volume and rate of venous flow, reduce oedema and stimulate anti-inflammatory processes. The pressure at the interface (IP) of the bandage and the skin is related to the elastic recoil of the product used and its resistance to expansion. The pressure difference between the IP in the supine and standing positions is called the static stiffness index (SSI). Elastic materials provide little resistance to muscle expansion during physical activity, resulting in small pressure differences between resting and activity, with an SSI <10mmHg. Stiff, inelastic materials with a stretch of <100% resist the increase of muscle volume during physical activity, producing higher peak pressures, an SSI of >10mmHg and a greater haemodynamic benefit than elastic systems. UrgoK2 is a novel dual-layer high-compression system consisting of an inelastic (short stretch) and elastic (long stretch) bandage, resulting in sustained tolerable resting pressure and elevated working pressures over extended wear times. It is indicated for the treatment of active venous leg ulcers and the reduction of chronic venous oedema. Each bandage layer has a visual aid to enable application at the correct pressure level. Published European studies have assessed this compression system, exploring its consistency of application, tolerability and efficacy. This article presents the first reports of health professionals' clinical experience of using the compression system in the US, where it has been recently launched. Initial feedback is promising.

Statischer Stiffness-Index von zwei Multikomponenten-Bandagen-Kompressionssystemen: Ergebnisse einer randomisierten kontrollierten Studie an gesunden Probanden

“…The FUSION study evaluated for the first time the performances on healthy volunteers of a new generation of multicomponent compression system, combining two different structures of compressive layers in one unique bandage. The results of this RCT showed that this new system presents a similar profile to the control system, a multicomponent system composed by a shortstretch bandage and a cohesive bandage, widely used in the treatment of venous leg ulcer and oedema of venous origin [21][22][23]25]. Four hours after their application, both systems exerted similar stiffness, with high working pressures and moderate resting pressures.…”

“…Bei dem als Kontrolle verwendeten Kompressionssystem handelte es sich um ein Mehrkomponenten-Kompressionssystem, das eine gepolsterte Kurzzugbinde und eine kohäsive Langzugbinde kombiniert (UrgoK2, Laboratoires Urgo, Frankreich). Dieses System ist in der Behandlung von venösen Beinulzera und Ödemen venösen Ursprungs weit verbreitet (seit 2007 auf dem Markt) und sein Wirksamkeits-und Sicherheitsprofil wurde zuvor durch eine kontrollierte Zufallsuntersuchung (RCT) und mehrere Interventions-und Beobachtungsstudien nachgewiesen [20][21][22][23][24][25][26][27][28].…”

“…Als Vorstufe zur klinischen Entwicklung eines solchen Systems bestand das Ziel dieser Studie darin, bei gesunden Testpersonen die Leistungen einer neuen Generation von Mehrkomponenten-Kompressionssystem, das in einem einzigen Verband geliefert wird, in Bezug auf Steifigkeit, Schnittstellendruck und Akzeptanz mit denen eines gut etablierten Kontroll-Mehrkomponentensystems, das häufig bei der Behandlung von venösen Beinulzera und Ödemen venösen Ursprungs eingesetzt wird [20][21][22][23][24][25][26], zu vergleichen.…”

“…The compression system used as control was a multicomponent compression system combining a padded short-stretch bandage and a cohesive long-stretch bandage (UrgoK2, Laboratoires Urgo, France). This system is widely used in the treatment of venous leg ulcers and oedema of venous origin (commercialised since 2007) and its efficacy and safety profile has been previously established through a RCT and several interventional and observational studies [20][21][22][23][24][25][26][27][28].…”

“…As a preliminary step in the clinical development of such a system, the objective of this study was to compare, in healthy subjects, the performances in terms of rigidity, interfaces pressures and acceptability of a new generation of multicomponent compression system, delivered in one unique bandage, to that of a well-established control multicomponent system, widely used in the treatment of venous leg ulcers and oedema of venous origin [20][21][22][23][24][25][26].…”