Prospective, randomized, controlled trial comparing the effectiveness of adjustable compression Velcro wraps versus inelastic multicomponent compression bandages in the initial treatment of leg lymphedema.

BACKGROUND: Inelastic multicomponent compression (ICM) bandages applied by specialized medical staff are the standard of care for compression therapy of lymphedema of the extremities. However, new adjustable compression wraps (ACWs), which can be applied by patients themselves and, up to now, have been mainly recommended for the maintenance treatment phase of lymphedema, may be an important step toward the self-management of the initial treatment phase.
METHODS: This prospective, randomized, controlled comparative study assessed the effectiveness of an ACW in the treatment of leg lymphedema, compared with the traditional treatment with conventional IMC bandages. Included were 30 hospitalized patients admitted due to moderate to severe unilateral lymphedema (stages 2-3) of the leg. The primary outcome measures in both groups were reduction in volume of the affected leg and interface pressure after 2 and 24 hours. Patients were randomized into two groups of 15 patients: group A received ACW and group B received IMC bandages, both applied by experienced staff. After 2 hours, the staff replaced IMC bandages and the patients applied ACW, as previously instructed. Finally, compression was removed after 24 hours. Classic water displacement volumetry was performed before compression and after 2 hours and after 24 hours of compression. The interface pressure was measured immediately after application of compression, 2 hours after compression, before and after compression renewal, and finally, after 24 hours. Patients in the ACW group were allowed to adjust the wrap themselves when they considered it necessary.
RESULTS: The reduction in median volume after 2 hours was 109 mL (interquartile range [IQR], 64-271 mL; -3.1%) in the ACW group and 75 mL (IQR, 41-135; -2.4%) in the IMC group (not significant). After 24 hours, the reduction in median volume was 339 mL (IQR, 231-493 mL; -10.3%) in the ACW group and 190 mL (IQR, 113-296 mL; -5.9%) in the IMC group (P < .05). The interface pressure dropped significantly after 2 and 24 hours in the IMC group (-50% and -6%), but significantly less in the ACW group (-26% and -44%), mainly due to self-readjustment. The median pressures achieved after self-application of ACW (52 mm Hg; IQR, 44-61 mm Hg) were of the same order as those produced by the nurses after the first application of ACW (53 mm Hg; IQR, 39-59 mm Hg), with less variation.
CONCLUSIONS: In patients with moderate to severe lymphedema of the legs, ACW achieved a significantly more pronounced reduction in volume after 24 hours than IMC bandages. Patients were able to apply and adjust the device after being instructed in its use and after an initial 2-hour period of wear. Autonomous handling of ACW seemed to improve the clinical outcome and is a promising step toward self-management involving effective compression.

RCT Entities:   Population Interventions Outcomes