Here - EWMA 2013

72
EFFECTIVENESS OF AN ACELLULAR SYNTHETIC MATRIX IN THE TREATMENT
OF HARD-TO-HEAL LEG ULCERS
Free Paper Session: Devices and Intervention
71
Pressure time integral of compression devices to evaluate
oedema reduction
Free Paper Session: Devices and Intervention
Hugo Partsch 1 , Mosti Giovanni 2
Keith Harding 1 , Pat Aldons 2 , Helen Edwards 3 , Micheal Stacey 4 , Kathleen Finlayson 3 ,
Michelle Gibb 3 , Liz Jenkins 2 , Gary Shooter 3 , Derek Van Lonkhuyzen 3 , Emily Lynam 3 ,
1
Medical University of Vienna (Vienna, Austria);
Zee Upton 3 , Eva-Lisa Heinrichs 5
2
Barbantini Hospital (Lucca, Italy).
1 Department of Wound Healing, Cardiff University (Cardiff, Wales, United Kingdom);
Background: After application of a compression device to a swollen extremity the
pressure drops in a variable fashion, depending on underlying conditions of the treated
area (configuration and consistency of the tissue) and on the properties of the material
2 The Prince Charles Hospital (Chermside, Queensland, Australia);
3 Queensland University of Technology (Brisbane, Queensland, Australia);
4 Department of Surgery, Fremantle Hospital, The University of Western Australia
used (pressure, elasticity).The amount of pressure drop determines the time when the
(Fremantle, Australia);
device needs to be renewed.
5 Tissue Therapies Europe Ltd, Daresbury Innovation Centre (Cheshire, United
Aim: To evaluate the dose-response relationship between the pressure of a
Kingdom).
compression product and its oedema reducing effect not only by measuring the initial
Aim: Hard-to-heal leg ulcers are a major cause of morbidity in the elderly population.
pressure but by calculating a pressure time integral.
Despite improvements in wound care, some wounds will not heal and they present a
Material and Methods: In order to compare the pressure time integral of different
compression bandages and stockings the interface pressures of four compression
devices were measured every afternoon up to one week in 40 patients with leg-oedema (CEAP C3-C6), 10 for each material: a short stretch multilayer compression system*, a significant challenge for patients and healthcare providers. Therefore a multi-centre
cohort study was conducted to evaluate the effectiveness and safety of a synthetic,
acellular matrix protein as an adjunct to standard care in the treatment of hard-to-heal
venous or mixed leg ulcers.
long stretch multilayer compression system**, a double compression stocking (“ulcer
Methods: Primary effectiveness criteria were (1) reduction in wound size evaluated by
kit”) and a modified inelastic bandage***. The area under the pressure curves was
percentage change in wound area and (2) healing as assessed by the number of
calculated by summing up the daily trapezoid areas. Pressure time integrals were also
patients healed by end of the 12 week study. Pain reduction was assessed as a
calculated from several published studies in which volume changes of legs had been
secondary effectiveness criteria using VAS.
measured before and after varying time intervals between 2 days and one week.
Results: A total of 45 patients completed the Study and no difference was observed
Results: The results for the four compression products are summarized in the figure
between cohorts for treatment frequency. Healing was achieved in 35.6% and wound
below. To obtain pressure time integrals with inelastic bandages comparable to less stiff
size decreased in 93.3% of patients. Median wound area percentage reduction was
material the initial pressure after application needs to be much higher. The dose
70.8%. Over 50% of patients reported pain on the first visit and 82.6% of these reported
response relationship between the pressure time integrals and percent volume reduction
no pain at the end of the Study. The median time to first reporting no pain was 14 days
of the oedematous extremity showed that higher values did not correlate with more
after treatment initiation
volume reduction, while lower integrals did.
Conclusion: Time pressure integral is a more meaningful parameter for characterizing
the compression dose than just the initial pressure value after application.
Conclusions: It was concluded that the acellular synthetic matrix protein offers an
effective and safe adjunct to standard care in the treatment of hard- to-heal leg ulcers.
*Rosidal sys ®
**Profore ®
FREE PAPER SESSION: DEVICES AND INTERVENTION
EWMA 2013
COPENHAGEN
15-17 May · 2013
Danish Wound
Healing Society
55