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380 Compression therapy for venous ulceration
(a)
(b)
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(c)
Figure 31.1 Stages of venous ulcer healing with compres-
sion therapy:
(a) 1 month, (b) 2 months, (c) 3 months.
Figure 31.3 (a) Video microscopic image of a distorted,
torturous medial malleolar microvessel in a patient with chronic venous disease. (b) Florescent video microscopy demonstrating disruption of perimalleolar subcutaneous lymphatics in a patient with venous disease.
Figure 31.2 (a) Lipodermatosclerosis. (b) Large venous ulcer in the medial malleolar region.
31.2 Mechanism 381
Transmitted venous hypertension
Ulceration
Altered lymphatics
Epidermis
Dermis
Subcutaneous
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Tissue hypoxia/ malnutrition
Fibrin deposition and edema
Dilated capillaries
Arteriole
Venule
Figure 31.4 Abnormalities of capillary permeability are postulated to lead to leakage of plasma proteins, cytokines, and
white cells into the extravascular space. Perivascular fibrin cuff formation may contribute to poor wound healing by inhibit­ing the diffusion of nutrients and oxygen to the cells.
applied to an enclosed system of an incompressible uid is evenly distributed.4 e rigidity of a compression dressing promotes uid movement into the venous and lymphatic systems due to the pressure gradient created between the interstitial space and the intravascular space. e optimal pressure required to achieve a therapeutic hemodynamic eect is a matter of debate; however, the greater the pres­sure increase in the leg, the greater the force that pushes the uid back towards the heart. Gravity governs intravenous pressure, which changes depending on the body position, and this must be counteracted. Physiologically, the pres­sure in a leg vein reects the weight of the blood column between the site of measurement and the right atrium.5 In the supine position, the venous pressure will be between 10 and 20 mmHg. Using a sphygmomanometer cu contain­ing an ultrasound-permeable window (Echo Cu, VNUS Medical Technologies, Sunnyvale, CA), it can be demon­strated that in this position, lower leg veins will be nar­rowed by an external pressure of 10–20 mmHg and totally occluded by a pressure of 20–25 mmHg.6 Venous narrow­ing by such low external pressures may explain the eect of thromboprophylactic stockings used in a recumbent patient. ese stockings exert a pressure of between 15 and 20 mmHg and enhance venous blood ow velocity when the patient is supine. During standing, the intravenous pressure in the lower leg vein rises to around 60 mmHg, depending on the individual’s height. An external pressure of around 35–40 mmHg has been shown to narrow the veins, but a pressure of more than 60 mmHg is necessary to occlude the veins totally.
6
From these experiments, it may be concluded that major hemodynamic eects of compression in an upright subject may only be expec ted when the interface pressure of the com­pression device is higher than 35–40 mmHg. A safe upper limit of 60 mmHg for externally applied, sustained com­pression was proposed based on several microcirculatory
investigations.7 Intermittent pressure peaks ca n considerably exceed this upper limit.
8
Compression improves venous pump function in patients with CVI (CEAP classes C3–C6), depending on the interface pressure.9 Inelastic bandages that do not give way to changes of the leg circumference produce a more pronounced reduction of venous reux as measured by air plethysmography compared to elastic material applied with the same resting pressure.10 Inelastic bandages applied with a resting pressure of over 50 mmHg have been shown to demonstrate signicant reductions in ambulatory venous pressure (Figure 31.5) as measured in patients with severe CVI walking on a treadmill.
11
is eect may be explained by an intermittent occlu­sion of the leg veins exerted by the pressure peaks of 80 mmHg produced by an inelastic bandage during walk­ing. Such eects cannot be achieved with elastic stockings that increase the interface pressure during walking to values only 3–8 mmHg higher than the resting pressure.
12
A study regarding compression therapy use in ulcers secondary to both venous insuciency as well as arterial insuciency (Ankle Brachial Index [ABI] > 0.5, absolute ankle pressure >60 mmHg) showed that inelastic com­pression of up to 40 mmHg increases the venous pumping function to near normal without impedance of arterial per­fusion. Investigations in this work included laser Doppler ux close to the ulcer and at the great toe, transcutaneous oxygen pressure on the dorsum of the foot, and toe pres­sures to assess arterial perfusion. e ejection fraction of the venous pump system was obtained to assess ecacy of compression on venous hemodynamics. Compression of 31–40 mmHg on the venous pump increased the ejec­tion fraction from 33.9% to 62.6%. e arterial perfusion was not impeded and may have improved slightly given the raised arteriovenous gradient with increased venous
13
return.
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resolution of edema by the movement of uid from the interstitial space into the lymphatic circulation (Figure31.6) and counteracting leakage of uid out of the capillary. e observations correlate with the fact that elastic and non­elastic bandages reduce lower extremity edema in patients with CVI and venous ulceration. With edema reduction, the cutaneous and subcutaneous metabolism may improve because of enhanced diusion of oxygen and other nutri­ents to the cellular elements of the skin and subcutaneous tissues, thereby promoting ulcer healing.
A number of biochemical abnormalities have now been implicated in the etiology and chronicity of venous ulcer­ation. e eects of compression therapy on these altera­tions in biochemistry remain largely unknown. VEGF and tumor necrosis factor-α appear to participate in the tissue damage associated with chronic venous disease. Serum levels of both of these cytokines diminish in patients with venous ulcers treated with 4 weeks of compression therapy with four-layered bandaging. Reductions have correlated with ulcer healing as reected by reduced ulcer size.
16
Figure 31.5 Ambulatory venous pressures can be
measured with cannulation of a dorsal foot vein and a standard pressure transducer as deep venous pressures are transmitted directly to the dorsal veins of the foot.
ere are many possible local cutaneous mechanisms explai ning the benet of compression therapy. Improvements in skin and subcutaneous tissue microcirculatory hemo­dynamics are postulated. A direct and favorable eect on subcutaneous pressures was also described.
14,1 5
Supine perimalleolar subcutaneous pressure increases with elastic compression. is should create a Starling gradient favoring
31.3 PATIENT EVALUATION
Compression, like many other medical interventions, works best when patients understand their condition and the goals of therapy. Prior to the initiation of compression therapy for venous ulceration, patients must be educated about their chronic disease and the need to comply with their treatment plan in order to heal ulcers and prevent recurrence.
ere are several possible causes of chronic leg ulcers. Onlyabout 70% of leg ulcers have a venous origin. A deni­tive diagnosis of ulceration secondary to venous insu­ciency must be made prior to undergoing treatment with
Figure 31.6 Needle with transducer used to study subcutaneous pressures exerted by external compression devices such
as elastic stockings.
Straight
clamp
Needle
C-ARM
Transducer
Micrometer
Figure 31.7 Duplex scanning to detect venous reflux in
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response to cuff deflation with the patient upright and non-weight bearing is the standard in most vascular labo­ratories for the detection of venous reflux of the lower extremity axial deep and superficial veins.
compression therapy. A detailed history should be obtained, including medications and other medical issues that may pro­mote lower extremity edema and ulceration. Before the start of compressive therapy, venous insuciency and/or venous obstruction should be documented in the noninvasive vascu­lar laboratory (Figure 31.7) or, in selected cases, by venography.
Possible arterial insuciency should also be assessed by physical examination or noninvasive studies prior to ther­apybeginning. Coexisting arterial insuciency, especially if severe, is a recognized risk factor for the non-healing of venous ulceration.17 Compression therapy can be counter­productive in the presence of arterial insuciency, given that the already diminished skin perfusion pressure can be further decreased, resulting in an overall pro-ulcerogenic eect, as well as an increased risk of critical limb ischemia.18 Compression therapy must be used with extreme caution in patients with arterial insuciency and is essentially contraindicated in patients with an ankle brachial systolic blood pressure ratio of <0.5.
Finally, systemic conditions that aect wound healing and leg edema, such as diabetes mellitus, immunosuppres­sion, and malnutrition, should be sought and improved as much as possible before or during the course of compression therapy. Strong compression applied to both lower extremi­ties may shi a considerable amount of blood volume towards the heart, and is therefore potentially contraindi­cated in patients with severe cardiac dysfunction.
31.4 FORMS OF COMPRESSION THERAPY
31.4.1 Elastic stockings
Compression therapy is most commonly delivered with gradient elastic compression stockings. Gradient elastic
31.4 Forms of compression therapy 383
compression stockings, initially developed by Conrad Jobst in the 1950s, were made to simulate the gradient hydrostatic forces exerted by water in a swimming pool. Elastic compression stock ings are available in v arious compositions, strengths, and lengths, and can be customized for a particu­lar patient.
e benets of elastic compression stocking therapy for the treatment of CVI and healing of venous ulceration have been well documented. In a retrospective review of 113 venous ulcer patients, the use of below-knee, 30–40­mmHg elastic compression stockings, aer rst resolving edema and cellulitis if present, resulted in 93% ulcer heal­ing. Complete ulcer healing occurred in 99 of 102 (97%) patients who were compliant with stocking use versus six of 11 patients (55%) who were non-compliant (P < 0.0001). e mean time to ulcer healing was 5 months. Ulcer recurrence was less frequent in patients who were compliant with their compression therapy. By life table analysis, the rate of ulcer recurrence was 29% at 5 years for compliant and 100% at
19
3 years for non-compliant patients.
In this cross-sectional study of venous ulcer patients, mean age was 59years and 27% of ulcers were recurrent. Compliance with the use of stockings as instructed was very good. Not all centers, however, have had such favorable results with elastic com­pression stockings. Older, less compliant patients and populations with a higher percentage of recurrent or long­standing ulcers will likely not do as well.
Data on 3144 new chronic venous disease patients treated from 1998 to 2006 were reviewed to further characterize compliance with compression stockings. A total of 37% of patients reported either full or partial compliance; 63% did not use the stockings or abandoned them aer a trial period. A total of 30% of non-compliant participants could not specify a reason for non-compliance; 25% did not have a prescription; 14% did not feel that the stockings helped; 13% reported the eect of binding/“cutting o” circulation; 8% felt that the stockings were too hot to wear; 2% reported limb soreness; 2% reported poor cosmetic appearance; 2% stated that they were unable to apply the stockings; 2% reported itching or contact dermatitis; and 2% were non­compliant due to cost.
20
In addition to promoting ulcer healing, elastic compres­sion therapy can also improve quality of life in patients with CVI. In a recent prospective study, 112 patients with CVI documented by duplex ultrasound were administered a questionnaire to quantify swelling, pain, skin discolor­ation, cosmesis, activity tolerance, depression, and sleep alterations. Patients were treated with 30–40-mmHg elastic compression stockings. Overall improvement in symptoms severity scores was observed at 1 month aer initiation of treatment. Further ameliorations were noted at 16 months.
21
Elastic stockings as a treatment for venous ulceration have the advantage over bandages that their eects are oper­ator independent. Once applied, their eects are related to the strength of the stocking and independent of the patient. Stockings are less bulky than other forms of compression therapy and therefore perhaps more comfortable. ey can
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be worn with normal footwear and allow daily inspection of wounds. However, the stockings must be used to be eec­tive and they are easily removed or “forgotten” by the non­compliant patient.
Patient compliance with compression therapy is crucial in treating venous leg ulcers. It begins with patient educa­tion, being reinforced at every visit to the oce and the clinic. Many patients are initially intolerant of compression in areas of hypersensitivity adjacent to an active ulcer or at sites of previously healed ulcers. is can sometimes be overcome by initially tting the patient with lower-strength stockings followed by higher-strength stockings over a period of several weeks. An obvious disadvantage is the added expense of the “introductory” stocking.
Patients may also have diculty applying elastic stock­ings. Elderly, weak, or arthritic patients cannot easily apply elastic stockings. In one study of elderly (mean age: 72 years) and predominately female patients (69%), 15% of patients were incapable of applying stockings and 26% could only put them on with signicant diculty.22 Obese patients frequently cannot reach their feet and are dependent on family members for application of the stocking. Anumber of aids have been developed to assist in the application of elastic stockings. With open-toe stockings, an inner silk sleeve can be placed over the patient’s forefoot to allow the stocking to slide smoothly during application. e sleeve is removed through the toe opening aer the stock­ing has been placed. Another device allows the patient to load thestocking onto a wire frame. e patient then steps into the stocking and pulls the device upward, applying the stocking to the leg (Figure 31.8).
Recurrence of ulceration aer healing can be lessened
by the use of elastic stockings aer the ulcer has healed.
19,22
However, in this case, an additional problem can be the unwillingness of insurers to provide coverage for elastic stockings, in spite of evidence of the cost-eectiveness of elastic stockings in preventing ulcer recurrence.
23
Another indication of compression stockings is the pre­vention of post-thrombotic syndrome (PTS) observed in 25%–50% of patients following deep venous thrombosis (DVT). e clinical features are the same as those for CVI, and include a spectrum of symptoms and signs ranging from mild lower extremity swelling and discomfort to severe pain, to irreversible skin changes, and eventually ulceration.
Interestingly, the SOX trial, a recent randomized, pla­cebo-controlled trial, questioned the use of compression stockings for the prevention of PTS in patients with a rst­time proximal DVT.24 e study was conducted from 2004 to 2010 and followed for 2 years 410 patients who were blinded and randomly assigned to either compression stockings with a pressure of 30–40 mmHg or placebo stockings with less than 5 mmHg of pressure. e cumulative incidence of PTS was 14.2% in patients with the active compression stockings versus 12.7% in the placebo arm, indicating no advantage of compression stockings for preventing PTS. is trial was in opposition to two previous trials that did show sub­stantial benet of compression in this indication; however, those trials were open label, single center, and smaller.
25,26
erefore, while the utility of compression stockings for the prevention of PTS remains unclear, once PTS has developed, compression therapy remains a staple of treatment.
31.4.2 Paste boots
Figure 31.8 The so-called Butler device can be used to
aid in donning compression stockings. The patient loads the stocking onto the wire frame and then steps into the stocking and pulls the device upward, applying the stock­ing to the leg.
Another method of compression was invented by the German dermatologist Paul Gerson Unna in 1896. Unna’s boot has been used for many years to treat venous ulcers and is available in many versions. Unna’s boot is basically a form of compression bandages (see below). A typical Unna’s boot-type dressing is a three- or four-layer dressing and requires application by trained personnel. A rolled gauze bandage impregnated with calamine, zinc oxide, glyc­erin, sorbitol, gelatin, and magnesium aluminum silicate is rst applied with graded compression from the forefoot to just below the knee. Additional layers consist of a con­tinuous gauze dressing followed by an outer layer of elastic wrap, also applied with graded compression. e bandage becomes sti aer drying and the rigidity may aid in pre­venting edema formation. e resting pressure, measured on the distal lower leg immediately aer application, may be 50–60 mmHg in the supine position. Unna’s boot is changed weekly or sooner if the patient experiences sig­nicant drainage from the ulcer bed. Once applied, Unna’s boot requires minimal patient involvement and provides continuous compression and topical therapy. However, the Unna’s boot has several disadvantages. It is uncomfortable to wear for some patients because of its bulkiness. is may aect patient compliance. In addition, the ulcer cannot be
31.4 Forms of compression therapy 385
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monitored and the technique is labor intensive, with the degree of compression provided being operator dependent. Patients may also occasionally develop contact dermatitis to the components of Unna’s boot that may require discon­tinuation of therapy. In a 15-year review of 998 patients with one or more venous ulcers treated with Unna’s dressings, 73% of ulcers healed in patients who returned for more than one treatment. e median time to healing for individual ulcers was 9 weeks.27 Unna’s dressing has been compared with other forms of treatment. A randomized, prospec­tive study comparing Unna’s boot to polyurethane foam dressing in 36 patients with venous ulcers demonstrated a superior healing rate over 12 months in patients treated with Unna’s boot (94.7% vs. 41.2%).
28
31.4.3 Compressive bandages
e purported advantages of multilayered compressive dressings include maintenance of compression for a lon­ger period of time, more even distribution of compression, and better absorption of wound exudates. e pressure delivered by a compressive bandage depends upon the radius of the limb to which it is applied, the number of lay­ers applied, the elastic properties of the materials utilized in the bandage, and the wrapping technique of the health care personnel who apply the bandages. ere are a wide variety of compression materials with dierent textures available, resulting in bandages in which the elastic proper­ties and applied pressure are quite variable. Pressure, layers, components, and elastic properties (P-LA-C-E) are the deciding features that have to be considered when compres­sion bandages are applied.
on the elastic property of the material. “Strong” and “very strong” bandages clearly produce higher interface pressure values than those obtained by compression stockings.
31.4.5 Layers
Single-layer bandages will usually have an overlap of up to 50%. Multilayer bandages consist of several single layers.
31.4.6 Components
e components of a bandage are the dierent materials used for one compression bandage application. Besides their intended functions of padding, protection, or retention, they exert varying eects on the interface pressure and on the stiness of the nal bandage. Compression bandaging systems consist of at least two dierent bandaging materi­als applied over each other for the whole length of the leg (Figure 31.9).
31.4.7 Elastic properties
e usual dierentiation between elastic and inelastic compression material is based on in vitro measurements using dierent extensometer devices and assessing the rela­tionship between the power exerted to distend the bandage and the resulting stretch. Table 31.2 shows a classication system for single-layer, single-component materials.
Several layers of elastic bandages will create a bandage with increasingly inelastic properties. e same is true
29
31.4.4 Pressure
e pressure developed beneath a bandage is governed by the tension in the fabric exerted by the bandager, the radius of curvature of the limb, and the number of layers applied.
Several instruments are available to measure the inter­face pressure exerted by a compression device on an indi­vidual leg. In the supine position, pressure ranges in the gaiter area can be classied according to proposals from a recent consensus conference (Table 31.1).29 It must be stressed that the interface pressures exerted during stand­ing and walking will increase in a manner that depends
Table 31.1 Pressure ranges of compression bandages
measured in the supine position at the medial aspect of the lower leg where the tendon changes into the muscular part of the gastrocnemius muscle
Recommendation mmHg
Mild <20 Moderate 20–40 Strong 40–60 Very strong >60
Figure 31.9 Application of the initial layer of a multilayer
compressive wrap.
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Table 31.2 Inelastic and elastic bandage materials
Elastic
Inelastic
Extensibility
(%)
Examples Zinc paste Comprilan Ace bandage Velcro-band
devices
rigid
0–10 10–100 >100
Rosidal K Surepress (CircAid)
Short
stretch Long stretch
when two stockings are used over each other or when sev­eral components of dierent materials are applied. is is because of an increase in friction between the rough surfaces of dierent layers opposing the expansion of the elastic strain of the bers. Typical examples of bandages with high friction are cohesive bandages that adhere to the underlying layer and are adhesive to the skin bandages.
Elasticity of the materials used in a compressive ban­dage (or stocking) is determined by in vitro measurements that quantify the power required to distend or stretch the bandage and the resulting extension of the bandage: a so­called hysteresis curve.
29,30
In general, an attempt is made to achieve a pressure of about 40 mmHg at the gaiter area. “Strong” bandage material will need to be stretched less than “weak” bandage material to achieve this goal.
Compressive bandages have varying degrees of stiness, dened as the increase in pressure per centimeter increase in leg circumference.30 A higher stiness indicates relative inelasticity of the bandage. An inelastic bandage is dened as having a pressure increase of >10 mmHg when moving from a supine to standing position, whereas with an elas­tic bandage, the pressure increase is <10 mmHg. Relatively high-stiness (inelastic) bandages include the Pütter ban­dage, which consists of two 5-m long short-stretch bandages applied to the leg in opposite directions (e.g., Comprilan, Rosidal K, and Pütter bandage). e inelastic kits are com­posed of padding, foam material, short-stretch bandages, and a protecting hose layer (Rosidal sys bandage). e main component of these bandages is cotton, which is permeable to air, very well tolerated, and can be washed and reused (Comprilan and Rosidal). Applying several elastic layers over each other creates a bandage system with high stiness (Four-layer bandage and Profore). e nal bandage, when used according to the manufacturers’ instructions, will exert an interface pressure of about 40 mmHg on the distal lower leg in the resting position. e Coban2 layer kit con­sists of two layers with an adhesive surface. It is easy to apply and creates a stable, non-bulky bandage with high stiness.
ere are two main disadvantages of inelastic bandages. One is the loss of bandage pressure starting immediately aer bandage application. e initial resting pressure will decrease by about 25% within 1 hour of application, mainly due to a decrease in the volume of the limb. e second disadvantage is the fact that a good inelastic compression bandage is not easy to apply. It requires skills that must be learned with proper training. Bandages with inelastic
material should be applied with much higher initial tension than elastic bandages because of the fast pressure drop. An inadequate technique is the main reason for the poor clini­cal outcome described in several studies.
31
Examples of elastic bandages are Ace-bandage, Surepress, and Perfekta. Proguide is a kit consisting of a padding layer and a specially designed elastic bandage. Elongation of the bandage material leads to only a small pressure increase.7 Such bandages may exert a relatively high resting pressure, which will increase only minimally during walking (“low working pressure”). e main advantage of these bandages is that they are relatively easy to apply, whether by untrained sta or by the patients themselves. e main disadvantage is the high resting pressure and the uncomfortable feeling due to the constricting force of the elastic bers. is high resting pressure might be responsible for skin damage, particularly in patients with arterial occlusive disease and overexposed pressure sites, such as over the dorsal ankle tendon.
Several points should be considered when compressive bandages are applied:
Elastic bandages are easier to handle than inelastic
bandages and may be applied by untrained sta or by
patients themselves.
Inelastic material should be applied with much higher
resting pressure, pressing the bandage roll towards
the leg as if molding clay. e patient is encouraged to
immediately walk for at least 30 minutes to decrease
edema and thereby decrease the pressure being exerted
under the bandage.
In patients with a small ankle circumference, bandages
should be applied with much less tension using ample
amounts of orthopedic wool padding to protect the
tendon.
e initial turn may start at the base of the toes or be
placed around the ankle or between the heel and the
dorsal tendon to x the bandage. e ankle joint is
always bandaged with maximal dorsal extension of the
foot and the protruding tendon is carefully protected
with cotton-wool.
Overlapping can be carried out in a spiral fashion or
with gures of eight.
e proximal end of a knee-high bandage should cover
the level of the bular head.
e bandage must be applied with no gaps so that each
turn overlaps the previous turn by about 50%.
Bandage materials must be non-allergenic to avoid the
development of dermatitis.
Pads can increase local pressure over ulcers or rm
lipodermatosclerotic areas.
Pain may indicate arterial ischemia. In such cases, the
bandage must be removed immediately.
Bandaging of the lower leg is sucient for the majority
of patients with chronic venous disorders.
Walking exercises are essential to optimize the eect of
compression therapy. However, compression is also able
to reduce edema in immobile patients or in those with
31.4 Forms of compression therapy 387
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severely restricted mobility. Inelastic xed bandages are preferred for this indication because of the lower resting pressure.
Aer some walking, the pressure will drop because of the immediate removal of edema. In the edematous phase, the bandage will loosen aer a few days, and it should be renewed or over-wrapped with a short-stretch bandage. e same is advisable when exudate from the ulcer pen­etrates the bandage. is may occur particularly during the initial treatment phase, and the patient should be informed to come back if this happens. Generally, the bandage is changed every 7 days on average.
Stier, more inelastic bandages may have greater eects on measurements of deep venous hemodynamics. A study using air plethysmographic measurements of venous volume and venous lling index in limbs with venous ulcers treated with elastic long stretch versus inelastic short­stretch bandages found greater improvement in varicose veins and the venous lling index with the short-stretch, inelastic bandage.
10
A clinical study of a relatively sti bandaging system (multilayer wrap of orthopedic wool, crepe bandages, and Coban bandages) reported results in 148 ulcerated limbs (126 patients) that were refractory to simple wraps. At 12 weeks, 74% of ulcers had healed and measurements of com­pression declined only 10% over 1 week.
32
A direct comparison between an elastic and inelastic bandaging regimen has been performed. e authors ran­domized 112 venous ulcer patients to an elastic or inelastic bandaging group (n = 57 and n = 55, respectively). Larger ulcers took longer to heal with the elastic compression, but complete healing at 26 weeks was no dierent: 58% for the elastic bandage arm versus 62% in the inelastic system arm.33 Another study comparing multilayer bandag­ing versus relatively inelastic short-stretch bandaging for venous leg ulcers showed that ulcers treated with multilayer bandaging healed more quickly.
34
Authors from Serbia reported dramatic results in heal­ing very large venous ulcers with a heelless, open-toe, elastic, multilayered compression device knitted into a tubular conguration. A total of 138 patients with very large venous ulcers (20–210 cm
2
) were randomized to treat-
ment with the multilayered tubular device (n = 72) versus bandaging plus compression stockings (n = 66). Cumulative healing was 93% in the group treated with the multilayered tubular dressing and 51% in the other group.
35
Clearly, multilayer compressive bandages can be eective for healing of venous ulcers. Stier, short-stretch bandages may have greater eects on deep venous hemodynamics and perhaps demonstrate faster healing than more elastic bandages. Whether this provides overall increased clini­cal ecacy remains to be determined. Direct comparisons between dierent multilayer bandaging systems and between those systems and other methods of compression are needed.
e Venous Ulcer Study IV (VenUS IV) looked at the clinical eectiveness and cost-eectiveness of compression
two-layer hosiery versus four-layer compression bandages. is was a randomized controlled trial involving 453 par­ticipants from 34 centers in England and Northern Ireland. Study participants were stratied by ulcer duration and area, and then randomized to either hosiery or bandage compression therapy. e primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Median time to healing was 99 days (95% CI: 84–126) in the hosiery group and 98 days (95% CI: 85–112) in the bandage group, indicating that both treatment options have essentially equivocal healing rates. e economic analysis, however, revealed a signicant advantage to the hosiery group.
36
31.4.8 Legging orthosis
CircAid is a legging orthosis consisting of multiple pli­able, rigid, adjustable compression bands.29 ese bands wrap around the leg from the ankle to the knee and are held in place with Velcro (Figure 30.10). e device pro-
vides inelastic, rigid compression similar to an Unna boot with increased ease of application. Because the bands are adjustable, it can be tailored to the individual as limb edema decreases. e orthosis appears eective at promoting reso­lution of edema and is especially useful in patients who, for various reasons, are either unable or unwilling to wear com­pression stockings. is legging orthosis may be superior to elastic stockings at preventing limb swelling in patients with advanced venous insuciency.
Figure 31.10 Example of a CircAid compressive bandage.
Compression can be varied according to how tightly the Velcro straps are pulled.
37
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31.4.9 Pneumatic compression devices
Pneumatic compression devices can serve as adjuncts in the treatment of lower extremity lymphedema or venous ulceration. ese devices may be particularly applicable to patients who have severe edema or morbid obesity. Relative contraindications are arterial insuciency and uncon­trolled congestive heart failure.
Pneumatic compression devices that provide sequential gradient intermittent pneumatic compression have received the most attention. Results suggest improvement in ulcer healing, but this might be facilitated by the fact that pump patients elevate their legs for longer on a daily basis than non-pump patients. e intermittent compression has not gained widespread acceptance, despite the results of the few studies in this area indicating that pneumatic compression may be useful in the treatment of venous ulcers, especially those refractory to previous treatment with ambulatory compression alone.
38,39
31.5 STUDIES COMPARING SURGERY
VERSUS COMPRESSION
e current literature highlights the diculties of comparing various forms of compression therapy for venous ulcer treat­ment with venous surgery. At least two major reviews have concluded that insucient evidence exists to favor one form of compression over another. cient evidence to favor the use of adjunctive dressings, such as hydrocolloid dressings (DuoDERM), in addition to com­pression therapy to heal venous ulcers.41 Comparisons are hampered by a low number of randomized controlled studies, dierent patient selection criteria, variable use of compres­sion as an adjunct to surgical therapy, and potentially variable compliance with post-operative compression therapy.
e ESCHAR study evaluated the hemodynamic eects of added compression in patients with venous ulceration.
40,41
In addition, there is insuf-
Legs with open or recently healed venous ulcers were treated with multilayer compression bandages or supercial venous surgery plus compression (n = 112 legs vs. 102 legs, respec­tively). Venous relling time as measured by photoplethys­mography was the primary hemodynamic outcome. e ulcer healing rate was 64% at 24 weeks and nearly identical in the two groups. Although there was no benet to surgery regarding ulcer healing, the ulcer recurrence rate was halved
42,43
in those that underwent surgery.
e ESCHAR study
results can be applied to the use of endovenous techniques.
In a study from Italy, Zamboni et al.44 randomized 80 consecutive patients with 87 venous leg ulcers to treat­ment with compression or minimally invasive surgery. Healing was remarkable in both groups: 100% at 31 days in the surgical group compared with 96% at 63 days in the compression group (P < 0.02). Follow-up was 3 years and recurrence rates were 9% in the surgical group versus 38% in the compression group (P < 0.05). Quality of life was also better in the surgical group.
A British study randomized 76 patients with venous ulcer to treatment with a four-layer bandaging system or supercial venous surgery and a four-layer bandaging sys­tem. Healing occurred in 64% of the compression group and 68% of the surgical group (P = 0.75), with no signicant dierence in the time to ulcer healing and no dierences in health-related quality of life.
45
Why do these studies give such disparate results? e tri­als were similar in design, the patients nearly the same age, and the mean ulcer sizes no dierent, and yet the Italians stated that supercial venous surgery works as an adjunct to the treatment of venous ulcers, whereas the English concluded that supercial surgery added nothing to com­pression therapy. Details of the two studies may explain the dierent results. e Italians excluded ulcers >12 cm and patients with secondary reux or deep venous reux. e English patients had a mean of two previous episodes of venous ulceration. e Italian study did not provide
Guidelines 4.3.0 of the American Venous Forum on compression therapy for venous ulceration
No. Guideline
4.3.1 We recommend compression therapy to heal venous ulcers. 1 A
4.3.2 We suggest compression therapy to decrease the risk of ulcer recurrence.
4.3.3 We suggest the use of multicomponent compression bandage over single-component bandages for the treatment of venous leg ulcers.
4.3.4 We suggest enforcing compliance since it is integral to the success of compression therapy.
4.3.5 We suggest use of intermittent pneumatic compression when other compression options are not available, cannot be used, or have failed to aid in venous leg ulcer healing after prolonged compression therapy.
Grade of
recommendation
(1: strong;
2:weak)
2 B
2 B
2 A
2 C
Grade of evidence
(A: high quality;
B:moderate quality;
C:low or very low quality)
information on previous episodes of venous ulceration. At
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this time, one is le to conclude that supercial venous sur­gery may improve the results of compression therapy for venous ulceration in certain, more favorable subgroups of patients with venous ulcers.
REFERENCES
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= Key primary paper
★  
= Major review article
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