Affiliation:
1. Practice for Internal Medicine and Vascular Diseases, Halle, Germany
2. Practice for Vascular Diseases, Essen, Germany
3. Practice for General Medicine, Phlebology and Lymphology, Lützen, Germany
4. Practice for Vascular Medicine, Werl, Germany
Abstract
Objective: To evaluate the clinical performance, quality of life (QoL) and patient satisfaction with an innovative flat-knit compression garment for the daytime treatment of lymphoedema patients in daily routine. Method: In a prospective multicentre observational study, patients with leg or arm lymphoedema (stage I-II, International Society of Lymphology (ISL) standards, 2016) received a made-to-measure flat-knit compression class 2 JOBST Confidence (BSN-JOBST GmbH, Germany) thigh-high stocking or arm sleeve. Primary endpoint was the oedema status as determined by the mean sum of the circumferences at the beginning and the end of the wearing period. Secondary endpoints included QoL-related parameters and patient satisfaction with product features assessed through questionnaires. The observation period lasted three weeks. Results: A total of 97 patients (87 females, 10 males), of which 65 had leg lymphoedema and 32 had arm lymphoedema, received the study device. The oedema status was effectively maintained (slight reduction in mean sum of circumferences by –3.1±7.3cm; p=0.0001). For QoL-related parameters, the patients reported fewer limitations in work, leisure and psychological wellbeing after wearing the stocking or arm sleeve (all p-values <0.0001). They also experienced less limitations in function and movement, feeling of tension and heaviness, and fewer difficulties wearing clothes, shoes, jewellery or watches at study end (all p-values <0.0001). In terms of pleasant feeling on the skin, moisture management, softness of material, range of motion, overall wearing comfort and heat build-up under the garment, patients were more satisfied with the tested compression garment than with previously worn compression garments (all p-values <0.001). Conclusion: In this study, the tested innovative compression product increased patient satisfaction with the improved product features while the lymphoedema status was successfully maintained.