Comparison of 4-Layer Bandages and an Adaptive Compression Therapy Device on Intended Pressure Delivery

PURPOSE: To characterize and compare interface pressure profiles of an adaptive compression therapy (ACT) device and a traditional 4-layer bandage (4LB) system. DESIGN: A prospective, randomized, open-label, 1-arm, active controlled study. SUBJECTS: The sample comprised 12 healthy volunteers. METHODS: Subjects wore both devices for 8 hours on 3 consecutive days. Treatments were randomized to left and right legs. One clinician performed all applications and was experienced in the clinical use of both devices. Pressures were measured in seated and standing positions at the lower, mid, and upper calf immediately post application and after 1, 4, and 8 hours. RESULTS: Pressures achieved with the ACT were closer to targeted 40/30/20 mmHg graduated pressure values and were significantly less than the 4LB for corresponding sites/postures (P <.001). In the seated position, initial interface pressures (mean ± SD) for the ACT were 36.9 ± 4.9, 30.5 ± 4.5, and 21.0 ± 3.6 mmHg. Corresponding interface pressures for the 4LB were 52.5 ± 8.4, 57.5 ± 10.3, and 53.5 ± 12.9 mmHg. In the standing position, initial interface pressures for the ACT were 40.7 ± 4.8, 35.6 ± 4.5, and 21.1 ± 4.6 compared to 54.6 ± 12.5, 64.4 ± 10.9, and 53.7 ± 14.3 for the 4LB. At 1, 4, and 8 hours after application, the 4LB showed a significant progressive decline in interface pressure in both seated and standing positions (P <.001). Conversely, the ACT did not decrease over time and there was a slight but significant increase for lower and mid-calf sites in the seated position (P <.001). CONCLUSIONS: The ACT device provided more consistent interface pressures than the 4LB and the pressures achieved were consistent with contemporary venous ulcer therapy standards