Abstract
This study was conducted as a prospective, randomized, controlled trial at the Lymphedema Department at Nij Smellinghe Hospital in Drachten, The Netherlands, from January 2010 to August 2011.
The study enrolled 30 patients hospitalized for non-operative treatment of moderate to severe lymphedema of the leg, not responsive to ambulatory lymphedema treatment with compression and manual lymph drainage for at least 6 weeks. The participants were randomized into two groups. Group A was treated with the Juxta-Fit ACW (CircAid Medical Products, San Diego, CA, USA), consisting of an initial protective cotton tube liner covered by an adjustable inelastic compression wrap. The adjustable compression Velcro (ACV) wrap devices were individually tailored to patient legs. Group B was treated by means of a three-component Trico IMC system (BSN Medical GmbH, Hamburg, Germany) consisting of an initial protective layer (Tricofix; BSN Medical GmbH) and covered with two layers of synthetic cast wadding (Delta-Rol S; BSN Medical GmbH). Two layers of Trico (12 cm x 4 m) bandaging material were applied over the synthetic cast wadding.
In both groups, the initial systems were removed after 2 h. After the initial application, the patients in Group A reapplied ACVs in co-operation with the hospital staff, and they were further instructed as to how readjust the straps for the remainder of the study. In Group B, the staff applied new bandages during the following 24 h. After application of both compression systems, all patients were encouraged to move as much as possible. No other therapeutic intervention was performed before or during the study period.
Leg volumetry was performed on both groups before bandage application, after removal of the initial bandages (i.e. 2 h later), and after the second removal (i.e. 24 h later). Interface pressures were sampled in both groups by a PicoPress pressure transducer (Microlab Elettronica, Roncaglia di Ponte San Nicolò, Italy).
The median lymphedema leg volume before bandaging was 3570 mL for the ACV group, and 3268 mL for the inelastic multicomponent compression (IMC) bandages group. After 2 h, a median volume reduction of 3.1% was measured in the ACV group compared with 2.4% in the IMC group, which was not significant. After 24 h, the median volume reduction was 339 mL in the ACV group and 190 mL in the IMC group (P<0.05).
The median initial interface pressures were 53 mmHg for ACV and 49 mmHg for IMC bandages. In the next 2 h, interface pressures dropped significantly: by 26.1% under ACV, and 50% under IMC (both P<0.001). After 2 h, compression materials were reapplied: ACVs were reapplied by the patients under supervision, while IMC bandages by the staff. Median interface pressures after bandage renewal were 52 mmHg for ACV and 53 mmHg for IMC. After 24 h, median interface pressures decreased significantly to 33 mmHg underneath ACV and to 25 mmHg underneath IMC (P<0.001). Patients’ interventions in the ACV group were recorded. During the second phase of the study, nine patients made 26 readjustments: the ACV was tightened 14 times and loosened 12 times.
In the present study, there was significantly greater edema reduction by ACV after 24 h than with the IMC bandaging system, despite the same initial compression pressure. Patients were allowed to tighten ACVs when they felt them loose. This also led to an increase of the working pressure, producing a stronger massaging effect during walking. The ACV system was less bulky compared with IMC; therefore, it was easier for patients to wear shoes and to walk.
So far, ACV has been mainly used in the maintenance phase of lymphedema treatment. Patients’ involvement in their own treatment is a part of self-management and is becoming more and more common in chronic disease management. In principle, patients who are able to put on their shoes should also be able to apply the ACV system. In cases where self-application is a problem, such as extreme obesity, relatives may be able to take over home-therapy.
Stiff material generally exerts a stronger massaging effect during walking, but leads to an immediate pressure loss due to edema reduction. This disadvantage of pressure loss is compensated by the readjustment of the straps by the patients.
Cost effectiveness aspect was not included in the study deliberately, although ACV is much more expensive than a traditional IMC.
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