A randomized controlled non-inferiority study of adjustable compression wraps compared with inelastic multilayer bandaging used in the intensive complex decongestive therapy of lower leg lymphedema.

Abstract

Objective: To evaluate non-inferiority of adjustable compression wraps compared to inelastic multilayer bandaging in reducing lower leg volume during intensive complex decongestive therapy in patients with bilateral, symmetrical lymphedema. Secondary outcomes included application time, patient comfort, and side effects.

Methods: A prospective, randomized controlled non-inferiority trial was conducted on 24 patients with stage II-III bilateral leg lymphedema during a 10-day intensive complex decongestive therapy. Each patient received adjustable compression wraps on a randomized side, while the contralateral leg was treated with inelastic multilayer bandages. The primary outcome was the difference in volume reduction, measured by perometer for lower leg volume, with a pre-defined non-inferiority margin of 50 ml. Application time was measured. Subjective parameters were assessed with visual analogue scales (VAS, range 0-100).

Results: Adjustable compression wraps were non-inferior to inelastic multilayer bandages with a mean difference in volume reduction of 9.45 ml [-30.40, 49.26], with respect to the a priori defined non-inferiority margin of 50 ml. In a subsequent test on superiority, intraindividual differences did not differ significantly (p=0.629). Adjustable compression wraps took significantly less time to apply (8.4 minutes; p < 0.001), and patients rated them as more comfortable (median VAS-difference 30; p < 0.001). Both compression methods significantly reduced skin tightness, with no notable differences between treatments. Adjustable compression wraps showed fewer side effects, and 83.3% of participants indicated they would continue using them. No adverse events were attributed to the compression wraps.

Conclusions: Adjustable compression wraps proved to be an effective, non-inferior alternative to inelastic multilayer bandages for reducing lower leg volume in the intensive complex decongestion therapy, while superiority could not be demonstrated. Their advantages include shorter application time and improved patient comfort. Its potential for self-management makes them a promising option for lymphedema therapy, provided patients receive adequate training.