Compression therapy of leg ulcers with PAOD.

Objectives: To assess the clinical safety of a new short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) in patients with peripheral arterial occlusive disease (PAOD). This system combines a low resting pressure with a high working pressure. Methods: A pilot study was performed in 15 subjects with moderate PAOD, i.e. an ABPI of 0.5-0.8. Co-existing chronic venous insufficiency or leg ulcer was not mandatory. All subjects received the compression system which was reapplied at each study visit (days 1, 2, 3, 4, 7, 10, 14). The safety parameters were: sub-bandage pressure immediately after application, pressure-related skin damage, hypoxia-related pain, and adverse events. A product comfort questionnaire was completed at the last visit. Results: The average sub-bandage pressure of 30 mmHg defined by the protocol was achieved. No pressure-related skin damage or hypoxia-related pain was found. The reported adverse device effects were as expected for compression therapies, including dry skin and pruritus. The product comfort questionnaire completed by the subjects showed a good tolerability profile. Conclusion: The short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) was safe and well tolerated in subjects with moderate PAOD.

Macro- and microperfusion during application of a new compression system, designed for patients with leg ulcer and concomitant peripheral arterial occlusive disease.

OBJECTIVE: To investigate macro- and microperfusion during 14 days of treatment with a new 2-layer compression system (3M™ Coban™ 2 Lite), designed for patients with leg ulcer and concomitant peripheral arterial occlusive disease. METHODS: A single-centre, open-label, prospective pilot study was performed with 15 subjects suffering from peripheral arterial occlusive disease with an ankle brachial pressure index (ABPI) of 0.5-0.8, who volunteered to have their 'study leg' bandaged with the new system. Coincident leg ulcer or chronic venous disease was not mandatory. All subjects received the new compression system, which stayed in place from 1 up to 4 days according to scheduled study visits. The system was reapplied by study personnel at each clinical visit (days 1, 2, 3, 4, 7, 10 and 14). The study participation stopped after 14 days. At each clinical visit safety assessments were performed: measurement of acral pulsation to capture macroperfusion; laser Doppler fluxmetry to capture microperfusion; clinical signs of pressure related skin damage, hypoxia-related pain and sub-bandage pressure measurement. In addition, the leg volume was measured and a comfort questionnaire was completed. RESULTS: An average sub-bandage pressure in standing position of approximately 30 mmHg was measured at the B1 location immediately after bandage application. Laser Doppler fluxmetry demonstrated positive effects on microcirculation regarding vasomotion and respiratory reflux. No change of the cardiac signal appeared. For acrale pulsations a high intraindividual variability was found with no clear interference to the bandage application. No pressure-related skin damage or hypoxia-related pain was detected. CONCLUSION: After application of the new compression system in subjects with moderate PAOD, laser Doppler fluxmetry indicated significant improvements of the microcirculation. High variability and lack of correlation to clinical symptoms was found for the acral pulsation. The new compression system revealed a high grade of tolerability and a good safety profile.

Dogmas and controversies in compression therapy: report of an International Compression Club (ICC) meeting, Brussels, May 2011.

The International Compression Club (ICC) is a partnership between academics, clinicians and industry focused upon understanding the role of compression in the management of different clinical conditions. The ICC meet regularly and from these meetings have produced a series of eight consensus publications upon topics ranging from evidence-based compression to compression trials for arm lymphoedema. All of the current consensus documents can be accessed on the ICC website (http://www.icc-compressionclub.com/index.php). In May 2011, the ICC met in Brussels during the European Wound Management Association (EWMA) annual conference. With almost 50 members in attendance, the day-long ICC meeting challenged a series of dogmas and myths that exist when considering compression therapies. In preparation for a discussion on beliefs surrounding compression, a forum was established on the ICC website where presenters were able to display a summary of their thoughts upon each dogma to be discussed during the meeting. Members of the ICC could then provide comments on each topic thereby widening the discussion to the entire membership of the ICC rather than simply those who were attending the EWMA conference. This article presents an extended report of the issues that were discussed, with each dogma covered in a separate section. The ICC discussed 12 'dogmas' with areas 1 through 7 dedicated to materials and application techniques used to apply compression with the remaining topics (8 through 12) related to the indications for using compression.

3M Coban 2 Layer Compression Therapy: Intelligent Compression Dynamics to Suit Different Patient Needs.

PROBLEM: Chronic venous insufficiency can lead to recalcitrant leg ulcers. Compression has been shown to be effective in healing these ulcers, but most products are difficult to apply and uncomfortable for patients, leading to inconsistent/ineffective clinical application and poor compliance. In addition, compression presents risks for patients with an ankle-brachial pressure index (ABPI) <0.8 because of the possibility of further compromising the arterial circulation. The ABPI is the ratio of systolic leg blood pressure (taken at ankle) to systolic arm blood pressure (taken above elbow, at brachial artery). This is measured to assess a patient's lower extremity arterial perfusion before initiating compression therapy.1. SOLUTION: Using materials science, two-layer compression systems with controlled compression and a low profile were developed. These materials allow for a more consistent bandage application with better control of the applied compression, and their low profile is compatible with most footwear, increasing patient acceptance and compliance with therapy. The original 3M™ Coban™ 2 Layer Compression System is suited for patients with an ABPI ≥0.8; 3M™ Coban™ 2 Layer Lite Compression System can be used on patients with ABPI ≥0.5. NEW TECHNOLOGY: Both compression systems are composed of two layers that combine to create an inelastic sleeve conforming to the limb contour to provide a consistent proper pressure profile to reduce edema. In addition, they slip significantly less than other compression products and improve patient daily living activities and physical symptoms. INDICATIONS FOR USE: Both compression systems are indicated for patients with venous leg ulcers, lymphedema, and other conditions where compression therapy is appropriate. CAUTION: As with any compression system, caution must be used when mixed venous and arterial disease is present to not induce any damage. These products are not indicated when the ABPI is <0.5.

Classification of compression bandages: practical aspects.

BACKGROUND: Compression bandages appear to be simple medical devices. However, there is a lack of agreement over their classification and confusion over the use of important terms such as elastic, inelastic, and stiffness. OBJECTIVES: The objectives were to propose terms to describe both simple and complex compression bandage systems and to offer classification based on in vivo measurements of subbandage pressure and stiffness. METHODS: A consensus meeting of experts including members from medical professions and from companies producing compression products discussed a proposal that was sent out beforehand and agreed on by the authors after correction. RESULTS: Pressure, layers, components, and elastic properties (P-LA-C-E) are the important characteristics of compression bandages. Based on simple in vivo measurements, pressure ranges and elastic properties of different bandage systems can be described. Descriptions of composite bandages should also report the number of layers of bandage material applied to the leg and the components that have been used to create the final bandage system. CONCLUSION: Future descriptions of compression bandages should include the subbandage pressure range measured in the medial gaiter area, the number of layers, and a specification of the bandage components and of the elastic property (stiffness) of the final bandage.

A liquid film-forming acrylate for peri-wound protection: a systematic review and meta-analysis (3M Cavilon no-sting barrier film).

To undertake a systematic review of all reliable evaluations of the clinical performance and cost-effectiveness of a film-forming liquid acrylate in the protection of the chronic ulcer peri-wound skin. Results from searches were scrutinised by two reviewers to identify possible randomised controlled trials and full reports of these were obtained. Details of eligible studies were extracted and summarised independently by two reviewers using a data extraction sheet. Meta-analysis was used to combine the results of trials where the interventions and outcome measures were sufficiently similar. A total of nine eligible studies were identified. The review reveals that a liquid-film forming acrylate (Cavilon no-sting barrier film, 3M, Minneapolis, MN, USA) is a safe and effective skin barrier to protect the peri-wound area of chronic ulcers. There is no difference between the protective properties of different barrier methods that are used to protect the peri-wound skin around chronic ulcers. Compared with no treatment or a placebo, this liquid film-forming acrylate has a significant impact on the integrity of the peri-wound skin. In addition, it has significant benefits in terms of pain control and patient comfort, and its use may reduce nursing time.