Compression Stocking With 100% Donning and Doffing Success: An Open Label Randomised Controlled Trial.

OBJECTIVE: The aim of this study was to test whether an investigational two layer stocking exerting 27-29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23-32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking. METHODS: This was an open label randomised controlled trial, which included 47 patients. All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg. The primary end point was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking. Patients were randomly allocated to one of two groups. Both types of compression stocking were compared in each group for ease of donning and doffing in the manner of a crossover study. Subsequently, patients wore the stocking type assigned to their group for a whole day to evaluate comfort and the effect on diurnal leg volume. RESULTS: All participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p < .001). Unaided removal success was 100% with the investigational stocking vs. 66% for the standard stocking (p < .001). There was no significant difference in leg volume reduction between the study groups after a day of wear. The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001). CONCLUSION: The investigational stocking, which has no compression in the foot or heel area, is significantly easier to don and doff, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class.

A Wearable Compression Device to Normalise Calf Muscle Pump Function in Chronic Venous Insufficiency for Each Postural Position.

BACKGROUND: For the currently used compression therapy, the applied compression pressure is usually inadequate to exert an effective impact on the veins in different body positions. The aim was to assess the venous ejection fraction achieved by a new compression device which automatically adjusts the interface pressure to body position in an acute experimental setting. METHODS: A new portable, battery driven compression device providing pressure adjusted to allow for body position, and connected to a less or very stiff calf cuff wrap was tested. In patients with superficial venous incompetence, the ejection fraction (EF) of the calf pump was measured by strain gauge plethysmography. Applied in a random sequence, values achieved without compression, with the two cuffs, and with compression stockings exerting 23-32 mmHg, were compared. The applied compression pressures were simultaneously recorded in the supine and standing positions, and during walking. Comfort was assessed by a visual analogue scale (VAS) with 0 corresponding to very low comfort and 10 to very comfortable. RESULTS: In 16 patients with CEAP clinical stage C3-C6, EF without compression was 37%, increasing to 46.9% with stockings, to 64.8% (p < .001) by less stiff and to 75.5% (p < .001) by stiffer wraps. The median interface pressure (supine/standing) was 31/56 mmHg for the less stiff device, 32/68 mmHg for the stiffer device, and 23/26 mmHg for the stockings. The static stiffness index and the walking pressure amplitudes were significantly higher than those generated by the stocking, and the highest values were found with the stiffer wrap material. The device comfort was high both in the supine and standing positions (VAS 8 ± 2). CONCLUSIONS: The tested devices were comfortable at rest and haemodynamically effective during walking by automatically adjusting compression pressures to body position. They are significantly more effective than elastic stockings in improving EF. The system is able to overcome the problems of fast pressure loss by continuously re-adjusting the compression pressure.

Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology.

Guideline 1.1: Compression after thermal ablation or stripping of the saphenous veins. When possible, we suggest compression (elastic stockings or wraps) should be used after surgical or thermal procedures to eliminate varicose veins. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 1.2: Dose of compression after thermal ablation or stripping of the varicose veins. If compression dressings are to be used postprocedurally in patients undergoing ablation or surgical procedures on the saphenous veins, those providing pressures >20 mm Hg together with eccentric pads placed directly over the vein ablated or operated on provide the greatest reduction in postoperative pain.[GRADE - 2; LEVEL OF EVIDENCE - B] Guideline 2.1: Duration of compression therapy after thermal ablation or stripping of the saphenous veins. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after treatment. [BEST PRACTICE] Guideline 3.1: Compression therapy after sclerotherapy. We suggest compression therapy immediately after treatment of superficial veins with sclerotherapy to improve outcomes of sclerotherapy. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 3.2: Duration of compression therapy after sclerotherapy. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after sclerotherapy. [BEST PRACTICE] Guideline 4.1: Compression after superficial vein treatment in patients with a venous leg ulcer. In a patient with a venous leg ulcer, we recommend compression therapy over no compression therapy to increase venous leg ulcer healing rate and to decrease the risk of ulcer recurrence. [GRADE - 1; LEVEL OF EVIDENCE - B] Guideline 4.2: Compression after superficial vein treatment in patients with a mixed arterial and venous leg ulcer. In a patient with a venous leg ulcer and underlying arterial disease, we suggest limiting the use of compression to patients with ankle-brachial index exceeding 0.5 or if absolute ankle pressure is >60 mm Hg. [GRADE - 2; LEVEL OF EVIDENCE - C].

Do Compression Sleeves Reduce the Incidence of Arm Lymphedema and Improve Quality of Life? Two-Year Results from a Prospective Randomized Trial in Breast Cancer Survivors.

BACKGROUND: In a previous randomized controlled trial it has been demonstrated that arm compression sleeves worn immediately after breast cancer surgery, including axillary lymph node removal in addition to physical therapy are able to reduce the occurrence of early postoperative swelling and of arm lymphedema up to 1 year and to improve quality of life. The aim of the present investigation was to check the further development of the arm swelling in patients using compression sleeves or not, and to compare the quality of life in women treated due to breast cancer 2 years after surgery. MATERIALS AND METHODS: Twenty from originally 23 patients who still wore their compression sleeves (15 mmHg) and 21 from 22 patients who had been randomized into the control group without compression could be seen after one more year. Arm volume measurements were performed and quality of life (QLQ-C30 and QLQ-BR23 questionnaires) was assessed. RESULTS: Three from 20 patients in the compression group (CG) and 6 from 21 without compression showed arm lymphedema, defined by an increase of the arm volume exceeding 10% compared with the preoperative values. Significant improvement of several quality of life parameters were found in the CG. CONCLUSION: Light compression sleeves worn for 2 years are not only able to reduce the incidence of early postoperative edema and of lymphedema, but also lead to a significant improvement of important quality-of-life parameters like physical functioning, fatigue, pain, arm and breast symptoms, and future perspectives.

Physical Activity With and Without Arm Sleeves: Compliance and Quality of Life After Breast Cancer Surgery-A Randomized Controlled Trial.

BACKGROUND: After breast cancer surgery patients are at higher risk of lymphedema development and decreasing physical activity (PA), as well as decreasing health-related quality of life (HRQOL). The aim of the study was to compare the level of PA and HRQOL in women after breast cancer surgery using light arm compression with women not using compression 1 year after oncological treatment. METHODS AND RESULTS: Forty-five women were preoperatively randomly assigned to a compression group (CG, n = 23) or to no compression group (NCG, n = 22). Arm volumes were measured before surgery and 12 months thereafter. The CG received circular-knit sleeves in compression class 1 for daily wearing in the postoperative period up to 1 year. Both groups underwent a standardized physical exercise program. PA with the short version of International Physical Activity Questionnaire (IPAQ), compliance, and HRQOL by EORTC QLQ-C30 and QLQ-BR23 questionnaires was assessed in both groups 1 year after surgery. After 1 year observation the CG showed significantly lower mean affected arm volume compared to NCG. The total PA (calculated as the sum of vigorous moderate exercises and walking) was markedly higher within the CG, with no difference in particular IPAQ items. There were no correlations between reported PA items and observed arm/edema volume or body mass index changes. The QLQ-BR23 revealed only better sexual functioning (p = 0.014) and greater upset by hair loss in NCG (p = 0.01). CONCLUSIONS: The available data indicate that wearing compression sleeves neither interfere with the level of PA nor decrease quality of life 1 year after breast cancer surgery.

A New Two Component Compression System Turning an Elastic Bandage into an Inelastic Compression Device: Interface Pressure, Stiffness, and Haemodynamic Effectiveness.

INTRODUCTION: Bandage application does not exert consistent compression pressure, leading to extremely variable compression when applied to patients. A new elastic bandage can exert a predefined pressure independently of healthcare providers and the size of the wrapped limb. The bandage system includes a series of non-stretchable patches that when applied to the bandage make it stiff. The aim of this work was to assess, in an experimental setting, the venous ejection fraction (EF) from the lower leg and the tolerability of this new bandage in a group of patients affected by superficial venous incompetence. METHODS: EF was measured using strain gauge plethysmography under baseline conditions and the bandage was applied with a supine pressure of 20 and 30 mmHg, with and without the stiff patches, in 25 patients with severe venous reflux in the great saphenous vein. The interface pressure of the bandages was measured simultaneously in the medial gaiter area. RESULTS: All patients showed EF values that were significantly reduced compared with normal individuals. Elastic bandages with an average pressure of 20 and 30 mmHg in the supine position achieved a slight improvement in EF, and, after applying non-stretchable patches on the same bandage with similar resting pressure, EF was restored to its normal range (p < .001). Improvement in EF correlates with the pressure differences between standing and lying pressure and between muscle systole and diastole during exercise. CONCLUSION: This study confirms that inelastic is much more effective than elastic compression for improving impaired venous haemodynamics. The test material can be applied with a predetermined pressure, which considerably enhances the consistency of application, and it is easily transformed into an inelastic system just by applying stiff patches without any stretch and without significantly increasing the comfortable supine pressure.

Preventing Early Postoperative Arm Swelling and Lymphedema Manifestation by Compression Sleeves After Axillary Lymph Node Interventions in Breast Cancer Patients: A Randomized Controlled Trial.

CONTEXT: Breast cancer-related lymphedema (LE) remains one of the major long-term complications after surgery. Many reports showed the effectiveness of compression in breast cancer-related LE treatment, but randomized controlled trials evaluating compression garments for postoperative prevention are lacking. OBJECTIVES: The aim of the study was to evaluate the potential role of light arm compression sleeves for reducing the incidence of early postoperative swelling and of breast cancer-related arm LE. METHODS: A total of 45 women were pre-operatively randomly assigned to a group with compression of circular-knit sleeves in compression class I (15-21 mm Hg) for daily wearing (compression group [CG]; n = 23) or to a control group without compression (no CG, n = 22). Both groups underwent a standardized physical exercise program. Arm volumes were measured before surgery and one, three, six, nine, and 12 months thereafter. RESULTS: At one month, postoperative swelling was reduced only in CG. After 12 months, the average change of excess volumes (edema) reached -67.6 mL in the CG vs. +114.5 mL in the no CG (P < 0.001). Significantly less edema was seen in the CG after three, six, nine, and 12 months. No significant difference between groups in health-related quality of life (measured by EORTC QLQ-C30) was observed. CONCLUSION: Fifteen to 21 mm Hg compression sleeves in combination with physical activity may be a safe and efficient option to prevent postsurgical arm swelling and development of LE.

Report from the 2013 meeting of the International Compression Club on advances and challenges of compression therapy.

The International Compression Club, a collaboration of medical experts and industry representatives, was founded in 2005 to develop consensus reports and recommendations regarding the use of compression therapy in the treatment of acute and chronic vascular disease. During the recent meeting of the International Compression Club, member presentations were focused on the clinical application of intermittent pneumatic compression in different disease scenarios as well as on the use of inelastic and short stretch compression therapy. In addition, several new compression devices and systems were introduced by industry representatives. This article summarizes the presentations and subsequent discussions and provides a description of the new compression therapies presented.

Prospective, randomized, controlled trial comparing the effectiveness of adjustable compression Velcro wraps versus inelastic multicomponent compression bandages in the initial treatment of leg lymphedema.

BACKGROUND: Inelastic multicomponent compression (ICM) bandages applied by specialized medical staff are the standard of care for compression therapy of lymphedema of the extremities. However, new adjustable compression wraps (ACWs), which can be applied by patients themselves and, up to now, have been mainly recommended for the maintenance treatment phase of lymphedema, may be an important step toward the self-management of the initial treatment phase. METHODS: This prospective, randomized, controlled comparative study assessed the effectiveness of an ACW in the treatment of leg lymphedema, compared with the traditional treatment with conventional IMC bandages. Included were 30 hospitalized patients admitted due to moderate to severe unilateral lymphedema (stages 2-3) of the leg. The primary outcome measures in both groups were reduction in volume of the affected leg and interface pressure after 2 and 24 hours. Patients were randomized into two groups of 15 patients: group A received ACW and group B received IMC bandages, both applied by experienced staff. After 2 hours, the staff replaced IMC bandages and the patients applied ACW, as previously instructed. Finally, compression was removed after 24 hours. Classic water displacement volumetry was performed before compression and after 2 hours and after 24 hours of compression. The interface pressure was measured immediately after application of compression, 2 hours after compression, before and after compression renewal, and finally, after 24 hours. Patients in the ACW group were allowed to adjust the wrap themselves when they considered it necessary. RESULTS: The reduction in median volume after 2 hours was 109 mL (interquartile range [IQR], 64-271 mL; -3.1%) in the ACW group and 75 mL (IQR, 41-135; -2.4%) in the IMC group (not significant). After 24 hours, the reduction in median volume was 339 mL (IQR, 231-493 mL; -10.3%) in the ACW group and 190 mL (IQR, 113-296 mL; -5.9%) in the IMC group (P < .05). The interface pressure dropped significantly after 2 and 24 hours in the IMC group (-50% and -6%), but significantly less in the ACW group (-26% and -44%), mainly due to self-readjustment. The median pressures achieved after self-application of ACW (52 mm Hg; IQR, 44-61 mm Hg) were of the same order as those produced by the nurses after the first application of ACW (53 mm Hg; IQR, 39-59 mm Hg), with less variation. CONCLUSIONS: In patients with moderate to severe lymphedema of the legs, ACW achieved a significantly more pronounced reduction in volume after 24 hours than IMC bandages. Patients were able to apply and adjust the device after being instructed in its use and after an initial 2-hour period of wear. Autonomous handling of ACW seemed to improve the clinical outcome and is a promising step toward self-management involving effective compression.

Compression therapy in mixed ulcers increases venous output and arterial perfusion.

OBJECTIVES: This study was conducted to define bandage pressures that are safe and effective in treating leg ulcers of mixed arterial-venous etiology. METHODS: In 25 patients with mixed-etiology leg ulcers who received inelastic bandages applied with pressures from 20 to 30, 31 to 40, and 41 to 50 mm Hg, the following measurements were performed before and after bandage application to ensure patient safety throughout the investigation: laser Doppler fluxmetry (LDF) close to the ulcer under the bandage and at the great toe, transcutaneous oxygen pressure (TcPo(2)) on the dorsum of the foot, and toe pressure. Ejection fraction (EF) of the venous pump was performed to assess efficacy on venous hemodynamics. RESULTS: LDF values under the bandages increased by 33% (95% confidence interval [CI], 17-48; P < .01), 28% (95% CI, 12-45; P < .05), and 10% (95% CI, -7 to 28), respectively, under the three pressure ranges applied. At toe level, a significant decrease in flux of -20% (95% CI, -48 to 9; P < .05) was seen when bandage pressure >41 mm Hg. Toe pressure values and TcPo(2) showed a moderate increase, excluding a restriction to arterial perfusion induced by the bandages. Inelastic bandages were highly efficient in improving venous pumping function, increasing the reduced ejection fraction by 72% (95% CI, 50%-95%; P < .001) under pressure of 21 to 30 mm Hg and by 103% (95% CI, 70%-128%; P < .001) at 31 to 40 mm Hg. CONCLUSIONS: In patients with mixed ulceration, an ankle-brachial pressure index >0.5 and an absolute ankle pressure of >60 mm Hg, inelastic compression of up to 40 mm Hg does not impede arterial perfusion but may lead to a normalization of the highly reduced venous pumping function. Such bandages are therefore recommended in combination with walking exercises as the basic conservative management for patients with mixed leg ulcers.

Prospective, randomized, controlled trial comparing a new two-component compression system with inelastic multicomponent compression bandages in the treatment of leg lymphedema.

BACKGROUND: New, less-bulky, short-stretch compression bandages could be a valuable alternative in the management of lymphedema of the leg. OBJECTIVE: To compare the effectiveness of a two-component compression (2CC) system in the treatment of leg lymphedema with that of the traditional treatment with conventional inelastic multicomponent compression bandages (IMC). METHODS: Thirty hospitalized patients with moderate to severe unilateral lymphedema (stage II-III) of the leg were included. Patients were divided in two groups; one (n=15) received a 2CC, and the other (n=15) received IMC. Primary outcome was volume reduction of the affected leg; secondary outcome was loss of interface pressure. RESULTS: Median leg volumes before bandaging were 4,150 mL (2CC) and 4,360 mL (IMC). Median volume reduction after 2 hours was 120 mL (2.9%) with the 2CC system and 80 mL (1.8%) with IMC (p>.05). After 24 hours, volume reduction was 8.4% and 4.4% respectively (p>.05). Interface pressure dropped significantly within 2 hours of bandage application in both groups. CONCLUSION: Our results indicate that the 2CC system forms a suitable alternative to IMC in the conventional treatment of moderate to severe lymphedema.

Inelastic bandages maintain their hemodynamic effectiveness over time despite significant pressure loss.

BACKGROUND: It is widely believed that the loss of compression pressure of inelastic bandages is associated with a loss of efficacy in contrast to elastic material, which maintains its pressure and performance. This study compared the effect exerted by inelastic bandages vs elastic compression stockings on the venous pumping function in patients with severe superficial venous insufficiency immediately after application and 1 week later. METHODS: Ejection fraction (EF) of the calf pump was measured in 18 patients presenting with bilateral reflux in the great saphenous vein (CEAP C(3)-C(5)) without any compression and immediately after application of an inelastic bandage on one leg and an elastic compression stocking on the other leg. Measurements were repeated 1 week later, before compression removal. EF was measured using a plethysmographic technique. The changes of interface pressure of the applied compression products were recorded simultaneously with EF measurements. RESULTS: After application, bandages and stockings achieved a significant improvement of EF (P < .001) that was much more pronounced in the bandaged legs. The median resting pressure was 45 mm Hg (interquartile range, 41-48.5 mm Hg) under the stockings and 64.5 mm Hg (interquartile range, 51-80 mm Hg) under the bandages. After 1 week, EF was still significantly improved in the bandaged leg (P < .001), but not under the stockings. At this time, the pressure under the stockings was only slightly reduced (5.9% supine, 3.6% standing), but the mean pressure loss under the bandages was much higher (54.3% supine, 35.4% standing). CONCLUSION: The findings supporting inelastic compression are important in explaining the benefits of its use in chronic venous insufficiency. Inelastic bandages maintain their superior efficacy on the venous pumping function after a wearing time of 1 week, despite a significant loss of pressure.

Compression therapy in breast cancer-related lymphedema: A randomized, controlled comparative study of relation between volume and interface pressure changes.

OBJECTIVE: Short stretch bandages are very effective in the initial management of arm lymphedema. However, no studies to date have measured the pressure required to achieve specific amounts of volume reduction. The purpose of this study was to determine whether there is a difference between low and high-pressure bandaging in terms of therapeutically intended volume reduction of the compressed arm. METHODS: Experimental, randomized and comparative study with two study-groups consisting of high and low initial interface pressure bandages. Thirty-six hospitalized patients in Nij Smellinghe hospital suffering from moderate to severe unilateral breast cancer-related lymphedema not responsive to outpatient treatment were included. Bilateral arm volume was measured by inverse water volumetry before, after two hours and after 24 hours of bandaging. The amount of edema was calculated by subtracting the volume of the diseased arm from that of the contralateral side. Sub-bandage pressure was measured after bandage application and two hours later. Bandages were then re-applied and the pressure was measured again. Twenty-four hours later, the pressure measurement was repeated and bandages were removed for final volumetry. Patients were randomized into two groups: group A received low pressure bandages (20-30 mm Hg) and group B received high pressure bandages (44-58 mm Hg). The main outcome measures were reduction of arm volume and edema volume in the affected arm in both study groups. Secondary outcome parameters were changes in sub-bandage pressure and patient comfort. RESULTS: Median arm volume reduction after two and 24 hours was 104.5 mL (95% confidence interval [CI], 51.2-184.2) (-2.5%) (P < .0001) and 217 mL (95% CI, 143.9-280.2) (-5.2%) (P < .01) for group A and 56.5 mL (95% CI, -2.7-123.1) (n.s.) and 167.5 mL (95% CI, 105.2-316.1) (-4.2%) (P < .01) for group B, respectively. There was no statistically significant difference between the volume changes in group A and group B. After 24 hours, edema decreased by median percentage of 9.2% in group A and 4.8% in group B (n.s.). Bandages in group A were better tolerated. The sub-bandage pressure drop in the first two hours was between 41% and 48% in both treatment groups at both measuring sites. After 24 hours, the pressure drop was between 55% and 63%. No proximal swelling above the bandage was observed. CONCLUSIONS: Inelastic, multi-layer, multi-component compression bandages with lower pressure (20-30 mm Hg) are better tolerated and achieve the same amount of arm volume reduction as bandages applied with higher pressure (44-58 mm Hg) in the first 24 hours.

Dose-response of compression therapy for chronic venous edema--higher pressures are associated with greater volume reduction: two randomized clinical studies.

BACKGROUND: Two phase II clinical studies used an experimental, multi-chambered compression device with different cuff pressure combinations in subjects with leg edema and chronic venous insufficiency. The objective of each study was to evaluate the safety and the relative effects of different cuff pressure combinations to determine if edema reduction was dose-dependent. METHODS: Each study enrolled adults with chronic (>or=6 weeks) venous edema corresponding to CEAP C(3)-C(5). The test device could apply different pressures at the foot, gaiter, mid-calf, and upper-calf. In the first study, the following six sustained pneumatic compression (SPC) profiles were applied for six hours each: 20, 30, and 40-mm Hg at the gaiter with graduated SPC (ie, lower pressures at the calf); and 20, 30, and 40-mm Hg at the gaiter with nongraduated SPC (ie, the same pressures at the calf). In the second study, the following three intermittent pneumatic compression (IPC) profiles were applied for two hours each: 40, 50, and 60-mm Hg at the gaiter with graduated IPC (ie, lower pressures at the calf). Each study included a baseline profile with no compression and two-day intervals between profiles. Leg volume was measured before and after compression using the water-displacement method. RESULTS: A dose-response relationship was observed between increased SPC/IPC pressures and reduced limb edema. Limb volume was reduced most effectively with the highest pressures of 40-mm Hg nongraduated SPC and 60-mm Hg graduated IPC (136 mL and 87 mL, respectively); however, some subjects reported discomfort with these profiles. Limb volume was reduced by more than 100 mL with 30 to 40-mm Hg graduated SPC and by 69 mL with 50-mm Hg graduated IPC, and subjects rated these profiles as comfortable or very comfortable. Of the 28 study participants (12 SPC, 16 IPC), two subjects reported pain with 60-mm Hg IPC; no other adverse events were reported with SPC or IPC. CONCLUSION: Pneumatic compression was safe and well-tolerated, with a dose-response relationship between increased SPC/IPC pressures and reduced leg edema. To our knowledge, this is the first study to demonstrate a dose-relationship in compression therapy: higher pressures are associated with greater volume reduction in subjects with chronic venous edema.