Venous leg ulceration and compression therapy have been documented in history for centuries.1,2 Pictorial evidence shows compression being applied for lower leg ulcers in ancient Greece, which is credited to Hippocrates (4th Century BCE), and it is mentioned that King Henry VIII of England was afflicted by recurrent venous leg ulcers (VLUs).1,2
Notwithstanding advances in healthcare, VLUs still present a substantial burden for patients and health professionals worldwide.3 Chronic venous insufficiency (CVI) is stated to be a component in up to 80% of lower limb ulcers,4 with VLUs affecting approximately 1% of the population and 3% of people ≥80 years of age in westernised countries.5 With the ageing and increasing obesity of the population of the western world, global prevalence of VLUs is predicted to escalate dramatically.5
Compression therapy has been shown to play a critical role in the management of individuals with VLUs, and in recent years there has been the introduction of a number of different treatment options.6 This therapy improves venous return by the pressure applied to the veins, which consequently leads to a decrease in vessel diameter and in reduced transmural pressure.6 An efficient compression therapy should deliver stable support for the leg muscles that increases the effects of the muscle pump, which subsequently results in improved venous return, leading to oedema reduction as well as pain relief.6 Applying apposite external pressure enhances the valvular mechanism that successively reduces venous reflux and increases the calf pumping function.7 The amount and type of compression that provides best effect is in large part dependent on the underlying venous pathology.7
Grading is according to the level of compression the bandages generate.8 Strong compression therapy (around 40mmHg) is generally recommended for the treatment of VLUs while, in patients with mixed venous and arterial occlusive disease (Ankle–Brachial Pressure Index (ABPI) 0.6–0.8), reduced compression (around 20mmHg) may be applied.8,9 Moreover, it is stated that application of a multi-component bandage system is more effective than single-component bandage systems.10
Even with significant experience, there can be substantial interoperator differences in the amount of pressure applied to patients' affected lower limbs, resulting in compression bandages that may be applied incorrectly and, therefore, not providing the level of pressure necessary for proper ulcer management.11 Clinicians must have the skills and knowledge required for bandage application in order to decrease problems associated with an inadequate application technique.12 Problems associated with inappropriate application may include pressure damage, limb distortion, bandage slippage and ineffective pressure levels.12 Pressure indicators can increase the efficiency of application of these bandages in order for clinicians to be able to apply the correct pressure needed for effective therapeutic treatment.12
Two-layer bandage with pressure indicators
The two-layer bandage with pressure indicators (UrgoKTwo Compression Bandage with PresSure System, Urgo Medical, France) (2LB+I) comprises two dynamic layers: the short-stretch layer combines viscose and polyester wadding with a polyamide and elastane knitted layer. This is the first layer that would be applied in contact with the skin to spread the pressure uniformly over the limb and also allows for absorbency when needed.12 It should also be noted that this engineered contact layer is unique in its pliable tissue interface. It provides 80% of the compressive pressure of the system.
The second layer, a cohesive bandage, is made from acrylic, polyamide, elastane and natural latex or latex-free material. This layer provides the additional compression necessary to reach the required therapeutic pressure.12 The 2LB+I compression bandage system provides the PresSure System, which is designed to help clinicians achieve optimal levels of compression consistently: the oval pressure indicator becomes a circle when the correct bandage stretch is achieved, and, by overlapping the bandage to the bottom of the pressure indicator, a consistent 50% or two-thirds overlap can be achieved, depending on kit size and ankle circumference (Fig 1).12 This system is very different from a three-layer system which only has compression in its middle layer.
Objective
The objective of this paper was to review the literature providing the clinical outcomes of the 2LB+I system to ascertain the effectiveness of the therapy in providing the necessary therapeutic treatment while being a comfortable bandaging system for the patient and, for the clinicians, an easy and time-saving compression system to apply.
Method
The initial search was conducted in February 2021 on PubMed; no filters were applied in order to retrieve any published material. Specific descriptors/key words were used for the bibliographic search, including ‘leg ulcer’, ‘venous ulcer’, ‘compression’ and ‘bandage’. The methodology applied followed suggested guidelines13 which recommend using both the singular and plural forms of terms where an exact phrase is used, for instance, ‘venous ulcer’ and ‘venous ulcers’. Truncation (stemming) was also used to broaden the search to allow inclusion of various word endings and spellings so as to avoid missing any slight variation in the search term where singular words were used. Using a shorter term, for instance, ‘compres#’, yielded a large number of terms which were not relevant and therefore were eliminated. Where necessary, synonyms and different terminology were also adopted to maximise the search. British and American English spellings ensured that articles completed in different countries and/or from different journals were identified. Controlled vocabulary, that is, organised arrangement of words and phrases used to index content and/or to retrieve content through browsing or searching was used in order to perform a complete search (Medical Subject Headings (MeSH) Terms) again did not offer any new findings. Boolean connectors were also used: ‘OR’ was used to broaden the search, ‘AND’ was used to narrow the search.
No search limitations were implemented regarding date and language to allow for complete results. Clinical studies evaluating 2LB+I, including randomised control trials (RCT), interventional trials (RCT, comparative, non-comparative), observational studies, case series and case reports were included, while preclinical studies (i.e., in vivo animal model studies), editorials or letters, abstracts but no articles were excluded.
The trade name of the dressing was not included in the initial search (PubMed) but was used in the subsequent search that was conducted in Google Scholar. This was done to ensure that papers using generic and/or brand names of the product were all captured. The decision was taken to include all levels of studies including observational studies and case reports where possible. The decision was based on the concept that ‘clinical experience represents medical knowledge that might differ from evidence derived from clinical research and may give readers different expert viewpoints’.14
Results
A total of 32 publications were identified through PubMed. After assessment of the abstract and, if necessary, in some cases, review of the whole article, four papers were identified for the purpose of this paper. Other articles retrieved discussed other compression systems and, therefore, were eliminated. A further six publications were retrieved through Google Scholar to give a final total of 10 articles. Table 1 presents the objectives/methods and main results/conclusions of each publication found in relation to the search findings. The sequence followed is according to date of publication.
Table 1. Results from all searches after exclusions
| Author | Year | Retrieved from | Type/Country | Main objective/method | Main results/conclusions | |
|---|---|---|---|---|---|---|
| 1 | Benigni et al.15 | 2007 | PubMed | Prospective, non-comparative, open-label, phase III clinical study42 patientsFrance | Primary endpoint: reduction in ulcer surface area. Secondary endpoints: evolution of leg oedema and patient comfortSix-week follow-up | Mean surface reduction after six weeks was 58.5%, with 24% of the treated wounds healing in a mean time of 25.9±9.46 daysPatients considered the compression system had a better effect on quality of life, evaluated by parameters such as pain, heat, itching and general comfort, than the system worn before entry into the studyPatient concordance with the 2LB+I was excellent and 86% of leg ulcers improved or healed after 6 weeksLocal tolerance was considered very good |
| 2 | Hanna et al.16 | 2008 | PubMed | Open randomised study32 nursesUK | Nurses with experience of using compression bandages applied a four-layer bandage system, an inelastic bandage system and the 2LB+I to a healthy female volunteer | 25% of nurses applied very high pressures with the 4LB, achieving pressures >50mmHg; 75% achieved a pressure of <30mmHg when using the SSB. A pressure of 30–50mmHg was achieved with the 2LB+I. The SSB took the least time to be applied (mean: 1 minute 50 seconds) with the 4LB the slowest (mean: 3 minutes 46 seconds). A mean time of 2 minutes 5 seconds was taken to apply the 2LB+I. Over 63% of the nurses felt the 2LB+I was very easy to apply |
| 3 | Jünger et al.17 | 2009 | PubMed | Open randomised study24 healthy individualsGermany | Volunteers were bandaged by a single experienced investigator with one of the three compression systems on both legs. The pressure indicator was printed on all systems to reduce bias. Interface pressures were measured at inclusion (day 0) and on days 1, 3 and 7 using an air sensor system. The volume of the lower limb was measured on days 0 and 7 using a three-dimensional imaging system. Comfort and tolerability were also assessed | The performance, based on the loss of interface pressure compared with baseline, of the 2LB+I was partially better than that of the short-stretch system for maximal working pressure and loss of volume. The 2LB+I system and short-stretch system had similar results. No difference was observed between the 2LB+I and the 4-layer system for the maximal working pressure. The 2LB+I compared better than the two other systems for comfort and tolerability: 25% of the patients treated with the 4-layer system discontinued the treatment after 3 days because of painThe 2LB+I system maintained, over 1 week, a similar level of sub-bandage pressure similar to a 4-layer system and was partially better than short-stretch bandaging. The volunteers found 2LB+I more comfortable and tolerable than the other two systems |
| 4 | Lazareth et al.18 | 2012 | PubMed | Non-inferiority randomised controlled trial, conducted in 37 centres187 patientsFrance, UK and Germany | Patients were followed up every 2 weeks for a period of 12 weeks, or until full closure. Primary endpoint: % of leg ulcers that healed after the 12 weeks. Secondary endpoints: relative wound area reduction (RWAR), absolute wound area reduction (AWAR) and the % of wounds with RWAR ≥ 40%Patients were randomised to either the 2LB+I (n=94) or 4LB; n=93) system | By week 12, 44% of VLUs in the 2LB+I group and 39% in the 4LB group had healed (ITT analysis). The per-protocol (PP) analysis showed that complete wound closure was obtained in 48% and 38% of the 2LB+I and 4LB groups, respectively. A non-inferiority margin within –10% is considered as demonstrating a 95% and 97.5% confidence interval (p=0.001), respectively. The AWAR was 6.6cm2 in the test group and 4.9cm2 in the control group. The percentage of wounds with a RWAR ≥40% was 47% and 44% for the 2LB+I and 4LB systems, respectively. Pain between dressing changes was reported in 27% of the test group and 40% of the control group, and the incidence of adverse events was 17% and 25%, respectively. The 2LB+I system was considered to be significantly easier to apply than the 4LB (p=0.038) |
| 5 | Crebassa and Allaert19 | 2020 | Google Scholar | Prospective observational study102 patientsFrance | Describe the clinical characteristics and evolution of patients with VLUs treated with the 2LB+I and evaluation of the nurses' perspectives | At baseline, the VLUs had a median area of 5cm2, reduced to 2cm2 (p<0.05) at the last follow-up visit, i.e., a reduction of 60.0% in 39 days on average. The median PUSH score** decreased from 11 to 9 (p=0.05) and the % of wounds with high levels of exudate decreased from 26.4% to 9.4% (p<0.05). 93.9% of nurses found it easy or very easy to apply the 2LB+I. 75.8% felt that the procedure was facilitated by the 2LB+I and 78.8% also felt more confident in the effectiveness of the compression |
| 6 | Lantis et al.20 | 2020 | Google Scholar | Retrospective observational study20 patients (23 wounds)US | Tolerability and acceptability of the 2LB+I were recorded at each patient visit over 4 weeks from the initiation of treatment with the tested system | All patients perceived accuracy of application was rated as very easy/good and, for all but one patient, ease of application was regarded as very easy/good. Accuracy was measured by the ease with which appropriate pressure was applied, as gauged by clinical observation of the PresSure system (when the ovals became circles). Similarly, a large majority rated the conformability of the 2LB+I and its effect on adherence as very easy/good (17/20 and 18/20, respectively). 75% of the sample rated its ability to avoid slippage as very easy/good, and 14/20 gave this score for patient ability to wear footwear. From 10 reports, a mean percentage reduction of 67.9% (median 80%, range 0–100%) |
| 7 | Murray and Norrie21 | 2020 | Google Scholar | Prospective observational study13 patientsUK | Observation of outcomes following the implementation of an evidence-based pathway including compression by 2LB+I and Technology Lipido-Colloid–Nano-Oligo Saccharide Factor and polyacrylate fibres (UrgoStart Plus) | With treatment according to the VLU clinical pathway, all but one patient healed within 12 weeks.This local pathway is an example recommended by the NICE medical technology guidance (MTG42)* adoption support resources for UrgoStart for treating diabetic foot ulcers and venous leg ulcers |
| 8 | Boey et al.22 | 2020 | Google Scholar | Case studies2 patientsSingapore | Observation of outcomes for 2 patients with VLU managed with 2LB+I and Technology Lipido-Colloid–Nano-Oligo Saccharide Factor (TLC-NOSF) (UrgoStart dressing) | Wound closure and a favourable patient and clinician experience were reported in both cases within the 3 months of evaluation and follow-up |
| 9 | Conde-Montero et al.23 | 2020 | Google Scholar | Open non-comparative clinical trial50 patientsSpain | Objectively assess and independently analyse the effect of 2LB+I and Technology Lipido-Colloid–Nano-Oligo Saccharide Factor (TLC-NOSF) (UrgoStart dressing) on the healing outcomes of VLUs treated with lozenge grafts | Clinical evaluation and photographs were taken every 2 weeks for a period of up to 12 weeks or until complete re-epithelialisation. All the patients analysed healed within 30 days (median, range: 14–72 days) |
| 10 | Stücker et al.24 | 2021 | Google Scholar | Prospective observational study702 patientsGermany | Patients in 103 centres in Germany with VLUs and/or with lower limb oedema due to CVI were treated with 2LB+I for a mean±standard deviation duration of 27±17 days | By the last visit, 30.9% of wounds had healed and 61.8% had improved. Limb oedema was resolved in 66.7% of patients and an improvement of ankle mobility was reported in 44.2% of patients. The skin condition under the compression therapy was also considered as improved in 73.9% of patients and a substantial reduction of pain was achieved, both in number of patients reporting pain and in pain intensity. Compression therapy with the evaluated system was ‘very well’ or ‘well’ tolerated and ‘very well’ or ‘well’ accepted by >95% of patients. These positive outcomes were in line with the general opinion of physicians on the evaluated compression bandages, which were judged ‘very useful’ or ‘useful’ for >96.6% of patients. Similar results were reported regardless of the treated condition, VLU and/or limb oedema |
PUSH Tool (Pressure Ulcer Scale for Healing)26; 2LB+1—UrgoKTwo Compression Bandage with PresSure System, Urgo Medical;
4LB—4-layer bandage; SSB—short stretch bandage; ITT—intention to treat; VLU—venous leg ulcer; CVI—chronic venous insufficiency
Discussion
Graduated compression therapy is recognised as the gold standard for the management of VLUs and it has been shown that this treatment can certainly increase not just the healing rates of VLUs, but also reduce the risk of recurrence.27,28 Nonetheless, compression therapy is still grossly underused globally.29 Various reasons are indicated for this lack of use, including lack of clinician knowledge of and competence in using compression systems, and patient unwillingness to wear compression.29 Both clinicians and patients may also lack understanding of the importance and purpose of treatment.29 The lack of implementation of compression therapy in the management of VLUs signifies a serious problem for achieving positive outcomes for these patients.17 The long list of pitfalls in adherence to compression may also include discomfort related to heat and tightness of the bandaging, interference with patient lifestyle including wearing normal shoes, and practitioner error in application.30
The evidence listed in this review regarding the 2LB+I relates to the delivery of care, i.e., effective compression, but many papers highlight the ease of application which provides greater confidence for clinicians, as well as the results regarding better patient responses. The prospective, non-comparative, open-label, phase III clinical trial15 demonstrates this by stating the surface area reduction of the VLUs (mean surface reduction after six weeks: 58.5%, with 24% of the treated wounds healing in a mean time of 25.9±9.46 days and 86% of leg ulcers improved or healed after six weeks) but also highlights that the patients considered that the 2LB+I system had a ‘better effect on quality of life, evaluated by parameters such as pain, heat, itching and general comfort, than the system worn before entry into the study’.15 Moreover, adherence was 86%, and local tolerance was considered very good.
Specifically, the effectiveness of the indicators to direct appropriate compression and overlap was shown in an open randomised comparative study16 where the clinicians applied the bandages in a shorter time and, importantly, at a better stretch and overlap to provide the recommended pressure.17 The conclusion of an open-label RCT on healthy volunteers18 discusses that, while providing performance and level of sub-bandage pressure, over seven days, comparable to four-layer bandages, the 2LB+I was better in comfort and tolerability when compared with four-layer bandages. Of the patients treated with the four-layer system, 25% discontinued the treatment after three days due to pain.18 These results are analogous to other results achieved in an RCT, involving 187 patients from three European countries, where the non-inferiority to four-layer compression bandaging was established and, in addition, the 2LB+I provided better patient comfort and better ease of application.19
Since the initial search, a further prospective, multicentre, observational study involving 702 patients with VLUs from 103 centres in Germany has been published.24 The results showed that, by the end of the study, after a mean treatment duration of 27 days ‘30.9% of wounds had healed and 61.8% had improved. Limb oedema was resolved in 66.7% of patients and an improvement of ankle mobility was reported in 44.2% of patients. The skin condition under the compression therapy was also considered as improved in 73.9% of patients and a substantial reduction of pain was achieved, both in number of patients reporting pain and in pain intensity. Compression therapy with the evaluated system was ‘very well’ or ‘well’ tolerated and ‘very well’ or ‘well’ accepted by >95% of patients. These positive outcomes were in line with the general opinion of physicians on the evaluated compression bandages, which were judged ‘very useful’ or ‘useful’ for >96.6% of patients. Similar results were reported regardless of the treated condition, VLU and/or limb oedema’. The results from this study complement the results of the literature retrieved from the initial search.
The authors concluded that this study also confirms the high level of performance and acceptability of the system, regardless of the characteristics of the wounds or patients at initiation of the treatment. The authors state that the data support the use of this multicomponent compression system as a first-line intervention in patients with symptoms caused by CVI.
Limitations
A limitation of this review is that some data might have been overlooked due to the lack of inclusion of other databases, such as EMBASE, CINAHL and SCOPUS. Nonetheless, the focus was predominantly on freely available databases and searches that would be available to the majority of clinicians not affiliated with an education faculty. The authors intention in not limiting searches to a particular language (i.e., English) was to reduce potential bias in the review process.
Conclusion
Management of patients with VLUs is complex, multifaceted and requires a close collaboration with patients to provide positive outcomes. It is an imperative that compression is part of VLU management; however, various papers and reports discuss the lack of adherence to this practice by both clinicians and patients.
Providing more clinicians with a more reproducible and easier-to-apply compression system may allow for more clinicians to provide appropriate compression earlier. In addition, the ability for more clinicians to provide appropriate compression provides the patients with a system that can be less painful and more comfortable, which can also encourage better adherence.
Partsch, who has significantly contributed to the research that led to the understanding of compression therapy, stipulates that: ‘The main problem concerning compression therapy is the lack of adequately trained staff. Some new compression devices which do not require special bandaging skills may replace conventional compression material in the future.’31 It is very likely that the presence of the visual indicator pressure system in the 2LB+I may be the bridge that covers this training gap.
The evidence provided in this paper demonstrates that the 2LB+I system provides continuous, consistent and comfortable compression that is easier to apply due to the indicator systems and therefore can be a system that may increase patient adherence and acceptability of the therapy, which will lead to a reduction in healing times of these hard-to-heal wounds.
Reflective questions
- Why is it not only important to apply compression in the management of venous leg ulcers (VLUs) but also to provide the correct pressure?
- How can a two-layer bandage save costs in comparison to a four-layer bandage?
- Understanding and giving importance to patient comfort is imperative in increasing adherence in compression bandaging. How true is this statement?
- As a clinician, how and why do you think that a compression system with indicators for pressure and overlapping is important in providing more accurate treatment in VLU management?