Compression

K-Two : efficacy , safety and acceptability of a new two-layer bandage system for venous leg ulcers

This study was a multi-centre, non-comparative, phase III clinical trial, conducted in 14 French vascular medicine departments and private vascular physicians. The aim was to evaluate the efficacy, the tolerance and the acceptability of a new two-bandage compression system K-Two in the local management of venous or mixed leg ulcers predominantly of venous origin.

42 patients from 12 centres were involved and followed-up during six weeks. The primary endpoint was the reduction in ulcer surface area, and secondary endpoints were the evolution of leg oedema and patient comfort. During the clinical study, patients underwent weekly clinical assessments and their ulcer surface area was measured by planimetry and photography every alternate week.

The results of the trial showed that the mean surface reduction after six weeks was 58,5%. Moreover, the patients considered that the new compression system had a better effect on quality of life (pain, heat, comfort) than the system worn before entry into the study. Local tolerance was considered very good.

This study showed that this new two-bandage compression system K-Two is effective and well accepted by patients.

 

 

 

 

 

 

 
  References
  • Benigni J.-P. Lazareth I., Parpex P., Alves M., Vin F., Meaume S., Senet P., Allaert F.-A., Sauvadet A., Bohbot S. Efficacy , safety and acceptability of a new two-layer bandage system for venous leg ulcers. Journal of Wound Care. 2007. 16 (9): 385 – 90.

A comparison of interface pressures of three compression bandage systems

The objective of this study was to compare the evolution of the interface pressure in different positions (supine, sitting, active standing) as well as the working pressure during exercise over a 7 days period, between three compression systems : a four-layer bandage system (4LB), a cohesive short stretch bandage (SSB) associated with a wadding layer and an innovative two-layer one developed by Laboratoires Urgo, K-Two. This study was made with 20 volunteers who were dressed with one of the three systems, on both legs, during 7 days. The results demontrate that KTwo is able to keep after one week a level of sub-bandage pressure similar to the 4LB and better than the SSB associated with a wadding layer, with a better comfort.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 References
  • Hanna R. A comparison of interface pressures of three compression bandage systems. British journal of Nursing, 2008 (Tissue Viability Supplement) 17(20): S16-24.

 

Comparison of the reproducibility of pressures between three compression bandage systems

The objective of this study was to test the reproducibility of the pressure of 3 venous ulcer compression systems : a four-layer bandage system (4LB), a cohesive short stretch two-layer bandage system (SSB) and KTwo which uses a performance indicator (etalonnage) to help define the correct pressure. 32 nurses with experience in compression bandage systems applied compression system to a female healthy volunteer (with an ankle circumference of 21 cm). The pressure measurements show that the majority of the nurses achieved a pressure of between 30-50mmHg without training with the new KTwo due to the etalonnage , whereas more personnel achieved very high pressure with the 4LB and the majority did not achieve 30mmHg when using the SSB. The nurses felt that KTwo offered advantages in terms of consistency of pressure due to the etalonnage. These results suggest that K-Two will offer the required therapeutic pressures and a good stability due to the etalonnage, whilst also offering less bulk, and likely patient compliance. This new two-layer bandage system will represent a suitable alternative to other compression bandage systems.

 References
  • Jünger et al. Interface pressure of three different multilayer bandage systems in healthy volunteers: results of a prospective randomized clinical study. Data on file, Urgo.