A randomized, controlled noninferiority study of adjustable compression wraps compared with inelastic multilayer bandaging used in the intensive complex decongestive therapy of lower leg lymphedema

Abstract

Objective

We evaluated the noninferiority of adjustable compression wraps compared with 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 noninferiority trial was conducted on 24 patients with stage II to 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 predefined noninferiority margin of 50 mL. Application time was measured. Subjective parameters were assessed with visual analogue scales (range, 0-100).

Results

Adjustable compression wraps were noninferior to inelastic multilayer bandages with a mean difference in volume reduction of 9.45 mL (95% confidence interval −30.40 to 49.26), with respect to the a priori defined noninferiority margin of 50 mL. In a subsequent test of superiority, intraindividual differences did not differ significantly (P = .629). Adjustable compression wraps took significantly less time to apply (8.4 minutes; P < .001), and patients rated them as more comfortable (median visual analogue scale difference, 30; P < .001). Both compression methods reduced skin tightness significantly, 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, noninferior alternative to inelastic multilayer bandages for reducing lower leg volume in the intensive complex decongestion therapy, although superiority could not be demonstrated. Their advantages include shorter application time and improved patient comfort. The potential for self-management makes them a promising option for lymphedema therapy, provided patients receive adequate training.