Randomized trial of cohesive short‐stretch versus four‐layer bandaging in the management of venous ulceration

Abstract

A multicenter prospective randomized clinical trial was undertaken to compare a generic four-layer bandage system with a cohesive short-stretch system (Actico, Activa Healthcare) in the management of venous leg ulceration. Both systems are designed to produce sufficient pressure to counteract venous hypertension. Patients in leg ulcer services with leg ulceration were screened for inclusion in this trial. Patients with arterial disease (ankle brachial pressure index < 0.8) and causes of ulceration other than venous disease were excluded. For patients with bilateral ulceration, the limb with the larger area of ulceration was studied. Patients were randomized to receive either type of compression bandage and simultaneously randomized to one of two foam dressings that were changed weekly unless more frequent changes were clinically required. In all, 156 patients met entry criteria and were randomized from the 12 clinical centers with median (range) ulcer size of 4.33 (0.33-123.10) cm(2). Analysis revealed that after 24 weeks a total of 111 (71%) of patients had complete ulcer closure, 32 (21%) had withdrawn from the trial, 12 (8%) remained with open ulceration, and one patient had died. Of the 74 patients randomized to the four-layer bandage, 51(69%) had ulcer closure on treatment compared with 60/82 (73%) on the cohesive short-stretch system. Intention-to-treat analysis produced a hazard ratio for healing of 1.08 (95 percent CI 0.63-1.85, p= 0.79). Withdrawal rates were similar between groups (15, 20% four-layer bandage; 17, 21% cohesive short-stretch system). Ulcer closure rates for patients treated with the cohesive short-stretch system were similar to those for patients managed by the four-layer bandage system in this trial.

Influence of Different Materials in Multicomponent Bandages on Pressure and Stiffness of the Final Bandage

“…The lack of in vivo measurement of the whole bandage can lead to considerable misunderstandings: several articles comparing elastic and inelastic bandages consider Profore an elastic bandage 17–27 while, in reality, it has inelastic properties thereby defeating their comparison, and even a recent Cochrane review 28 classifies Profore as a “four‐layer elastic multi‐layer bandage.” As our results demonstrate, pressure and stiffness of the final bandage can change considerably by modifying the padding layers in a kit. In fact we obtained surprising data by exchanging padding layers between Proguide and Rosidal sys provided that we applied the outer layers as recommended by the manufacturers.…”

A Combined Therapy Protocol to Improve Lower Extremity Muscle-Pumping Function and Lymphatic Drainage for Venous Ulcer Healing

“…Some studies evaluating compressive techniques reported greater healing times than those found in our sample or included subjects with smaller ulcer sizes. For instance, a trial comparing cohesive short stretch versus four-layer bandaging reported healing rates of 56% at 12 weeks in both groups [22]. Another study evaluating multilayer bandaging reported the median healing time in the treatment group at 133 days [23].…”

Wound duration and healing rates: Cause or effect?

“…Such disparity between baseline data to such a degree is unusual, and this trial was also confounded by differing baseline wound sizes but emphasizes that care is needed when studying patients with chronic wounds. Studies have excluded recruitment of patients with ulcers greater than 52 weeks old …”