Customizing elastic pressure bandages for reuse to a predetermined,sub-bandage pressure: A randomized controlled trial

Abstract

Objective

A randomized clinical trial was performed to compare the effectiveness of unmarked bandages and customized bandages with visual markers in reproducing the desired sub-bandage pressure during self-bandaging by patients.

Method

Ninety patients were randomly allocated to two groups (“customized bandages” and “unmarked bandages”) and asked to perform self-bandaging three times. The achievement of a pressure between 35 and 45 mmHg in at least two of the three attempts was defined as adequate quality.

Results

Adequate quality was achieved by 33.0% when applying the unmarked bandages, and 60.0% when applying the customized bandages (p = 0.02). Use of the customized bandage and previous experience of bandaging were independent predictors for the achievement of the predetermined sub-bandage pressure (p = 0.005 and p = 0.021, respectively).

Conclusion

Customized bandages may achieve predetermined sub-bandage pressures more closely than standard, unmarked, compression bandages.

Clinical trials registration

ClinicalTrials.gov (NCT02729688). Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer. https://clinicaltrials.gov/ct2/show/NCT02729688

Keywords

Compression compression bandage chronic venous insufficiency

Introduction

The conventional treatment for venous leg ulcers (VLUs) involves the use of graduated compression bandages. They work by improving the calf-muscle pump and by augmenting venous tone, both of which facilitate venous drainage.¹ The pressure beneath the bandage itself depends on the tension in the fabric of the elastic bandage, the radius of the curvature of the limb, the width of the elastic bandage, and the number of layers applied.² The ability to apply a bandage at the correct pressure is largely dependent on the skill of the individual applying the bandage.^3,4 Such factors are important because insufficient compression can lead to delayed ulcer healing, while a higher pressure leads to skin complications. Studies have shown that compression bandages achieving sub-bandage pressures of 35–45 mmHg in the gaiter region above the ankle joint provide a safe and effective treatment for chronic venous insufficiency.⁴

To standardize the degree of compression achieved, bandages are customized for individual patients by drawing a shape with an ink marker when the bandage applied by the nurse has achieved a 35–45 mmHg sub-bandage pressure.⁵ The drawn shape later serves as a visual calibration to guide the patients in achieving the desired pressure to be exerted by the bandage on their leg.

We used this principle to customize compression bandages using direct feedback from the interface pressures and a rubber ink stamp in vivo once the target pressures had been achieved.⁵ To reduce the variability in the interface pressures, we prepared individual, elastic bandages with a visual guide. These were termed a “customized, elastic bandage with pressure guide” (CEB-PG).⁵ To obtain the appropriate pressures, an experienced nurse applied the elastic bandages to a patient with a sub-bandage pressure monitor in place. Once the target pressure of 35–45 mmHg was achieved, a circular ink stamp was applied to the entire bandage. When the bandage was removed and returned to a non-stretched state, the mark on each CEB-PG appeared as an elliptical, rather than a circular, shape. Upon the CEB-PG being reapplied to the patient’s leg, the mark reverted to the circular shape as the bandage was stretched, permitting the exact desired pressure to be reattained while allowing for the individual shape, size and contour of that patient’s leg.

It can be challenging to have consistent, quality, compression therapy applied by patients, caregivers or family members without the aid of a healthcare practitioner. Although the effectiveness of reproducing the desired sub-bandage pressure of a CEB-PG when applied by medical staff has been proven,⁵ its effectiveness when applied by a patient without the aid of a healthcare practitioner has not previously been studied.

Methods

This study was done at the ulcer clinic of the Division of Vascular Surgery, Department of Surgery, Siriraj Hospital, Mahidol University from 1 March 2016 to 1 March 2017. Included were patients with chronic venous insufficiency who were aged 18–70 years and presented with hyperpigmentation, lipodermatosclerosis, or healed or active VLUs. The exclusion criteria were patients who had fragile thin skin over bony prominences, peripheral arterial disease, an ankle brachial index of less than 0.9, or a recent diagnosis of heart failure; patients who were unable to perform self-bandaging; or patients who had an allergy to elastic bandages. Using computer-generated randomization software, the patients were randomly allocated in a 1:1 ratio to two groups to perform compression bandaging with either ordinary elastic bandages (OEBs) or CEB-PGs.

Study protocol

In the OEB group, an experienced nurse demonstrated to the patients how to apply OEBs to cover the whole of the lower leg. The bandage began at the foot area at the metatarsophalangeal joint, followed the course of the toes, and encompassed the heel. The starting end of the bandage was fixed with two circular routes. Graduated compression was performed. The bandaging was applied in a spiral, with three elastic bandages being applied with a 50% overlap from the foot to just below the knee.² Because there was no visual guided marker on the OEB, the patients then performed the bandaging once by themselves under the guidance of the trainer. Next, the patients performed the OEB bandaging three additional times by themselves, but without any assistance from the training nurse. On each of those three occasions, a second nurse measured the sub-bandage pressure with a PicoPress (Microlab Elettronica, Ponte S. Nicolo, Italy); the patients were blinded to the sub-bandage pressure results.

As for the CEB-PG group, an experienced nurse made individualized CEB-PGs for each patient by applying three elastic bandages to each patient with sub-bandage pressure monitoring by a PicoPress. Once the target pressure of 35–45 mmHg was achieved, a circular ink stamp was applied over the entirety of the bandages (Figure 1). The mark for each CEB-PG took on an elliptical shape when not stretched, but returned to a circular shape when stretched (Figure 2). After that, an experienced nurse demonstrated to the patients how to apply CEB-PGs to cover the whole of the lower leg. The techniques for applying the CEB-PGs were the same as those for the OEB group, except that the bandage was stretched until the elliptical mark became circular. The patients then performed CEB-PG bandaging once by themselves under the supervision of that nurse. The patients were next asked to perform CEB-PG bandaging three times by themselves, without any help from the training nurse. On each of those three occasions, another nurse measured the sub-bandage pressure with a PicoPress, blinding patients to the results.

Figure 1.

Equipment for preparing the customized elastic bandage with pressure guides. Shown are the elastic bandages, ink stamps and PicoPress for sub-bandage pressure measurement.

Figure 2.

The customized elastic bandage with pressure guides. (a) The elliptical shape of the bandage before stretching. (b) The change in the elliptical shape marker into a circle when the bandage is stretched helps patients to apply the bandage with the correct stretch and pressure. (c) A representative image of a customized elastic bandage once applied to the leg of a patient.

The PicoPress measurements of the sub-bandage pressures were made after the patients deemed that they had finished each bandaging. The instrument’s transducer pad was placed about 12 cm above the inner ankle at the medial aspect of the lower leg, where the tendon changes into the muscular part of the gastrocnemius muscle. This point is known as point B1, as per a previous report.¹ For measurement purposes, the participants were placed in the supine position, and the resting pressure was measured (Figure 3).

Figure 3.

Flow diagram demonstrates the steps in the study.

In the supine (resting) position, a pressure of 35–45 mmHg was considered optimal,^6,7 and we considered participants who achieved an optimal pressure in at least two out of the three bandaging attempts to have performed compression bandaging of adequate quality. Those who achieved an optimal pressure in only one or none of the three bandaging attempts were considered to have performed compression bandaging of inadequate quality. The quality of bandaging of the OEB and CEB-PG groups were then compared.

The elastic bandage (Medigauz; Thai Gauze Co., Ltd., Bangkok, Thailand) had a maximum stretch capacity that exceeded twice (+100%) its original size, and was 4.50 m long and 10.16 cm wide. Its composition was 35% cotton, 30% polyester and 35% Spandex.

Ethical considerations

All participants gave informed consent. The present study’s protocol was approved by the Institutional Review Board of Mahidol University (016/2559[EC4]), and it was registered at ClinicalTrials.gov (NCT02729688). The study was supported by the Siriraj Research Development Fund (managed by Routine to Research: R2R no. 15SU00033/028/15) of the Faculty of Medicine, Siriraj Hospital, Mahidol University.

Sample size

The sample size was calculated based on testing for non-inferiority with a power of 80% and a two-sided significance level of 5%. According to our previous study,⁵ the success rate in the intervention group (P1) was 0.70, and the success rate in the control group (P2) was 0.33. Using nQuery Advisor 5.0 (Statistical Solutions, Clearwater, FL, USA), a sample size of at least 45 patients per group was needed to demonstrate the efficacy of CEB-PG.

Statistical analysis

Data were prepared and analyzed using PASW statistics 18.0 (SPSS Inc., Chicago, IL, USA). The quantitative data were described as mean and standard deviations (SD), or as medians and ranges, as appropriate. Frequency and percentages were used to express qualitative data. Independent sample t-tests or Mann–Whitney U tests were used to compare the quantitative data of the two study groups, as appropriate. The qualitative data were then compared using Pearson’s chi-square test, Yates’ continuity correction, or Fisher’s exact test, as appropriate. Finally, a multivariable Poisson regression was used to examine the independent factors associated with clinical success. The adjusted relative risks (RRs) and corresponding 95% confidence intervals (95% CIs) were used to evaluate the strength of association between the independent factors and the achievement of adequate, sub-bandage pressure. All tests of significance were two-tailed, and a p-value of < 0.05 was considered statistically significant.

Results

Of the 114 consecutive patients with chronic venous insufficiency screened for eligibility for this study, 24 were excluded, comprised of 22 who declined to participate because of inability to perform bandaging and 2 who did not meet the inclusion criteria (Figure 4). No patient dropped out of this study. Therefore, a total of 90 patients were randomized to the OEB and CEB-PG groups (45 patients each). Their baseline characteristics are described at Table 1, which shows that there were no statistically significant differences in age, sex, body mass index, leg circumference, CEAP (clinical, etiologic, anatomic, and pathophysiologic) classification, underlying disease, previous bandaging experience, patient status or physical activity between the two groups.

Figure 4.

CONSORT flow diagram of patients participating in the study.

Table 1.

Baseline characteristics of participants by group.

	OEB group (n = 45)	CEB-PG group (n = 45)	p-Value
Age (years) Mean ± SD	57.87 ± 12.25	60.47 ± 11.46	0.192
Median (range)	57 (28–82)	63 (31–79)
Sex Male (%)	16 (35.6%)	18 (40.0%)	0.828
Female (%)	29 (64.4%)	27 (60.0%)
Weight (mean ± SD; kg)	73.23 ± 13.4	68.83 ± 14.93	0.125
BMI (mean ± SD; kg/m²)	27.63 ± 4.74	25.60 ± 4.56	0.713
Ankle circumference
mean ± SD (cm)	25.45 ± 4.10	23.72 ± 3.04	0.507
Median, range (cm)	24 (18–38)	23 (19–31.5)
Calf circumference (mean ± SD; cm)	37.75 ± 5.96	36.38 ± 5.29	0.309
CEAP classification
C4a	6 (13.3%)	6 (13.3%)	1.000
C4b	6 (13.3%)	7 (15.6%)	0.764
C5	13 (28.9%)	10 (22.2%)	0.629
C6	20 (44.4%)	22 (48.9%)	0.833
Underlying disease
Diabetes mellitus	8 (17.8%)	5 (11.1%)	0.549
Hypertension	24 (53.3%)	20 (44.4%)	0.527
Dyslipidemia	19 (42.2%)	13 (28.9%)	0.271
Coronary artery disease	4 (8.9%)	1 (2.2%)	0.361
Chronic kidney disease	0 (0%)	1 (2.2%)	1.000
Stroke	3 (6.7%)	2 (4.4%)	1.000
Previous Bandaging experience	28 (62.2%)	22 (48.9%)	0.289
Patient status			1.000
self-active	44 (97.8%)	44 (97.8%)
Partial-dependent	1 (2.2%)	1 (2.2%)
Physical activity			0.384
Chair/bedbound	1 (2.2%)	0 (0.00%)
Walking inside aids	3 (6.7%)	1 (2.2%)
Walking outside unaided	0 (0.00%)	1 (2.2%)
Walking freely	41 (91.1%)	43 (95.6%)

CEB-PG: customized elastic bandage with pressure guides; OEB: ordinary elastic bandage.

The following numbers of patients achieved a compression bandaging of adequate quality (35–45 mmHg) in at least two of their three bandaging attempts: 15 (33.0%) in the OEB group, and 27 (60.0%) in the CEB-PG group (p = 0.02), as shown at Table 2. Independent factors associated with clinical success for bandaging were identified by a Poisson linear regression; we established that using the CEB-PG (adjusted RR = 1.93, p = 0.005) and having previous experience of using compression bandaging (adjusted RR = 1.74, p = 0.021) were independent factors for the achievement of an adequate sub-bandage pressure (Table 3).

Table 2.

Compression bandaging of adequate quality and excellent quality between the study groups.

	Participants, n (%)		p-Value
	OEB (n = 45)	CEB-PG (n = 45)	p-Value
Compression bandaging of adequate quality	15 (33.3)	27 (60.0)	0.02
Compression bandaging of excellent quality	6 (13.3)	10 (22.2)	0.68

Note: Compression bandaging of adequate quality meant that patients achieved the optimal pressure (35–45 mmHg) in at least two of the three bandaging attempts. Compression bandaging of excellent quality meant that patients achieved the optimal pressure (35–45 mmHg) in all three of the three bandaging attempts. CEB-PG: customized elastic bandage with pressure guides; OEB: ordinary elastic bandage.

Table 3.

Independent factors associated with achievement of adequate sub-bandage pressure for self-bandaging.

Factors	Crude RR (95% CI)	P-value	Adjusted RR (95% CI)	p-Value
CEB-PG	1.80 (1.12–2.90)	0.016	1.93 (1.21–3.07)	0.005
Previous bandaging experience of the patients	1.60 (0.98–2.60)	0.059	1.74 (1.09–2.80)	0.021

CEB-PG: customized elastic bandage with pressure guides; RR: relative risk.

Discussion

Compression therapy is recognized as the most effective treatment for VLUs,⁸ with effective compression known to accelerate ulcer healing. However, the efficacy of compression bandaging is highly dependent on the skills of healthcare workers, the relatives who care for the patients, or the patients themselves.⁴ Whether the sub-bandage pressure is adequate often remains unclear, but it can significantly affect outcomes.

In previous studies, the introduction of objective devices to measure the sub-bandage pressure, in combination with training, was shown to improve bandaging skills among healthcare workers.^4,9,10 To improve compression bandage quality, we developed a customized elastic bandage that used a visual guide. Compression by the elastic bandage was applied to each patient with sub-bandage pressure monitoring to achieve an interface pressure of 35–45 mmHg at the B1 point, and a circular marker was placed on the bandage, while stretched, at the target pressure; this marker subsequently served as a guide when reapplying the bandage.⁵

In our previous study, the CEB-PG led to increased rates of optimal sub-bandage pressures when applied by healthcare practitioners who treated two volunteers with different leg circumferences.⁵ In this study, the results showed that CEB-PGs are more likely to achieve predetermined, sub-bandage pressures more closely than the standard, unmarked, compression bandages when applied by the patients themselves, and without the assistance of a healthcare practitioner. We also identified that the achievement of an adequate sub-bandage pressure could be improved among patients who had previous experience of bandaging themselves. Training patients for self-bandaging with a CEB-PG could optimize the efficacy of self-bandaging.

A CEB-PG – a multilayer, single-component system that facilitates consistent compression with an elastic bandage – can be easily applied by a healthcare practitioner, a caregiver, a family member or the patient. In addition, it is a cheap and reusable method. Moreover, it can be applied to legs of varying sizes and shapes. This may be of particular value among patients with advanced lipodermatosclerosis, in which the proximal leg swells and the lower leg shrinks from chronic ulceration, resulting in an inverted, champagne-bottle appearance of the lower leg.¹¹ Moreover, a CEB-PG comprised of multiple layers of elastic bandage is stiffer than a single-layered, long-stretch bandage because of the frictional forces acting between the multiple layers.¹²

We also controlled for several confounders. To avoid a learning effect between each bandaging attempt, the participants did not know whether their previous efforts had been successful. The sub-bandage pressure in the supine position has also been measured in many studies.⁴ Finally, the PicoPress system is a portable, digital gauge specifically designed to measure the pressure exerted by a bandage, and its reliability and reproducibility have already been demonstrated. It is recognized as one of the best systems for measuring the interface pressure.^1,13

A variety of available devices have been used for compression therapy, such as multi-component systems (two-layer or four-layer bandages), two-layer component hosiery systems, and adjustable Velcro compression devices. Different types of bandages and bandage systems can provide sustained compression. Multi-component systems contain elastic material in combination with an adhesive or cohesive covering layer.⁸ The four-layer bandage is a multicomponent bandage consisting of four components: orthopedic wool, crepe bandage, elastic bandage, and elastic cohesive bandage. The two-layer bandages are characterized by use of elastic and inelastic components. They are easy to apply and may provide a suitable alternative to the four-layer bandage.

It has been reported that the two-layer and four-layer bandages achieved the required therapeutic pressure necessary for the management of venous leg ulcers. The multicomponent compression systems are usually more effective in the treatment of VLUs than single-component bandages.^8,14 The clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum suggest the use of multicomponent compression bandage over single-component bandages for the treatment of venous leg ulcers.⁸ However, multicomponent compression systems are also more expensive and, being more difficult for patients to apply themselves, require application by experienced nurses or doctors.¹⁵ Some patients do not like these disadvantages and decline compression.¹⁶ Multicomponent compression systems are suitable for active and mobile patients who have heavily-exuding wounds.¹⁶ However, multi-component compression bandage systems are also associated with significant limitations, including pressure loss, bulkiness, bandage slippage and decreased patient quality of life.¹⁵

Two-layer component hosiery systems are as effective as four-layer component bandaging systems for the healing of venous leg ulcers.¹⁷ However, the two-layer component hosiery systems are not suitable for heavily exuding wounds, and some patients have difficulty apply the stocking by themselves.¹⁶

Adjustable Velcro compression devices can be applied and adjusted by patients. They have been reported to be effective in the treatment of CVI.¹⁸ However, some patients consider that they look unsightly.¹⁶

Most of the previously mentioned compression systems come at a high cost for patients from developing and low-income countries. In addition, multicomponent bandage systems cannot usually be reused. In contrast, CEB-PGs are a single-component compression bandage system; although such systems are less effective than multi-component compression bandage systems, they can be made from any bandage material available in a hospital. CEB-PGs also enable wounds to be inspected daily and dressings to be changed frequently, especially in the case of patients with large VLUs that require frequent wound-dressing changes. Moreover, they are cheap and reusable.

Although the clinical benefits of CEB-PGs have not been examined in this study, the results indicate that that the desired pressure range is more likely to be achieved with CEB-PGs. The clinical benefits of CEB-PGs should therefore be studied in the future.

The usual way of applying compression bandaging is to make rectangles, squares and rugby-ball ellipses because this determines the tension of the fabric. Commercial bandaging systems with marks allowing patients to estimate the correct pressure are also available. The two-layer component bandage, Urgo K-Two, has pressure indicators on the bandages that have been shown to aid safe application, with accurate pressures being achieved consistently by the whole clinical team and with minimal training.¹⁹ However, this particular commercial bandage is not reusable. Its cost might therefore be out of the reach of low-income patients or developing countries. In addition, it is not recommended for use on patients with an ankle circumference over 32 cm.

The customization process of CEB-PG might be better than a conventional compression system, like Urgo K-Two, for several reasons. First, the exact sub-bandage pressure can be attained while taking into account the unique shape, size and contour of each patient’s leg. Moreover, CEB-PGs are easier to apply, and it is easier to reach the target pressure with CEB-PGs.

The sub-bandage pressure was measured about 12 cm above the inner ankle at the medial aspect of the lower leg, where the tendon changes into the muscular part of the gastrocnemius muscle (termed the B1 point), according to the consensus report.^4,7 We measured the sub-bandage pressure only as a single-pressure measurement at the B1 point. Whether the correct graduation, or how much graduation, was achieved was not evaluated. A future study should perform multiple points of sub-bandage pressure measurement to increase the effectiveness of bandaging.

In the present study, we used the only type of elastic bandage available in our hospital, and it is conceivable that the different elasticities of other elastic bandages might alter our outcomes. Our technique could also be adapted for any target pressure requirement, such as sub-bandage pressures of 20–30 mmHg after varicose vein surgery, or 50–70 mmHg for the treatment of lymphedema.

Patients who have coexisting peripheral arterial disease with an ABI between 0.5 and 0.9 can perform modified compression therapy. However, in our study, patients with a coexisting peripheral arterial disease were excluded to avoid the ischemic complication from a higher pressure. A further study should evaluate the effectiveness of using CEB-PGs on patients with an ABI between 0.5 and 0.9.

The mean patient age was 58 and 60, per group. As the population was relatively young, the study findings might not be as applicable to the geriatric population. The study population was only marginally overweight, with the BMI of each group being 27.6 kg/m² and 25.6 kg/m². Our studied population also does not represent a large proportion of patients with venous disease.

Although the success outcome for CEB-PGs was only 60%, it was better than the outcome for OEBs (33%). However, if the patients had had more skill in bandaging with CEB-PGs, the outcome might have been even better. This is a limitation of this research: we did not train until the patients were able to demonstrate that they could consistently perform CEB-PG bandaging well. This is significant given that our data showed that the patients’ bandaging skill level also affected the outcome.

Another limitation was the shape of the mark. We used the change from an elliptical to a circular shape to indicate the attainment of a suitable stretch. However, we observed that some patients did not stretch until the intended perfectly circular shape was exhibited. An elliptical-circular shape might therefore not be a suitable visual marker for this application; instead, a rectangular shape, or just the distance between two lines, might prove to be more accurate.

Bandaging systems, especially short-stretch bandages, show a fast reduction of sub-bandage pressure over time, even within a day. In our study, we measured the sub-bandage pressure of the CEB-PG right after bandaging. The loss of sub-bandage pressure of CEB-PGs over time should be evaluated by measuring sub-bandage pressure 2 or 3 h after bandaging. In addition, it would be interesting in a future study to repeat the pressure measurements after some months to see if there is a learning effect (indicated by high levels of correct pressures being attained), or whether worn-out bandages lead to fewer correct pressures being achieved.

Moreover, future studies should evaluate how the outcomes are affected by variables such as age group, BMI, target pressure, leg size, bandaging performed by relatives on patients unable to self-apply CEB-PGs, and type of elastic bandage.

Conclusions

Customized bandages which can be applied without the supervision of a healthcare practitioner may achieve predetermined, sub-bandage pressures more closely than standard, unmarked, compression bandages. The achievement of an adequate, sub-bandage pressure could also be improved among those patients who had had previous experience of bandaging. The CEB-PG method might therefore be an effective tool for self-bandaging among patients with chronic venous insufficiency.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The present study was supported by the Siriraj Research Development Fund (managed by Routine to Research: R2R no. 15SU00033/028/15), Faculty of Medicine, Siriraj Hospital, Mahidol University.

Ethical approval

All participants gave informed consent. The present study’s protocol was approved by the institutional review board of Mahidol University (016/2559[EC4]), and it was registered at ClinicalTrials.gov (NCT02729688).

Guarantor

Contributorship

NS contributed to the study design, data collection, data analysis, and writing; TT took part in the study design, data collection, and data analysis; RP was involved in data collection; NP, CW, KC, PM and CR took part in revising critically for important intellectual content. All authors approved the final version to be submitted.

Acknowledgements

The authors would like to acknowledge the Siriraj R2R team and the Siriraj Vascular Surgery (Syamindra1) nursing team for contributing to the work presented in this paper. The authors also thank Mrs Tipyanee Thinwilai and Miss Phakawan Phutthakunphithak for data collection, and Dr Sasima Tongsai for her statistical assistance.

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