“Comparing sub-bandage pressure and stiffness dynamics in two two-component compression systems for the lower limb: Influence of skill level and partial compression layer addition”

Abstract

Background

Two-component cohesive compression systems are available for compression therapy.

Objectives

To assess the sub-bandage pressure and stiffness of the two-component compression systems, Coban and CoFlex, and to investigate how an additional partial compression layer after two hours and the experience of the therapist impact these outcomes.

Methods

The study examined 19 patients whose lower limbs were bandaged by either a trainee or an experienced physical therapist. Sub-bandage pressures were measured using PicoPress® sensors placed 10 cm and 25 cm proximal to the medial malleolus. Additionally, the Static Stiffness Index (SSI) and Dynamic Stiffness Index (DSI) were calculated.

Results

The addition of a partial compression layer on the ventral side of the leg significantly increased sub-bandage pressure and DSI. SSI effects were significant at 10 cm, but not at 25 cm height. Coban generated significantly higher pressures than CoFlex, while the level of experience of the therapist showed no significant influence.

Conclusions

The addition of a partial compression layer effectively increases sub-bandage pressure, with Coban exerting higher pressure than CoFlex. However, the level of experience of the therapist does not significantly influence the compression outcomes.

Keywords

Bandaging two-component bandages sub-bandage pressure stiffness chronic edema

Introduction

According to international guidelines, compression therapy is a cornerstone in the management of fluid accumulation due to venous and lymphatic insufficiency (further named chronic edema) for both the reduction as the maintenance phase of treatment.^1,2 In the initial phase, (non-cohesive) short-stretch bandages are frequently utilized and have been demonstrated to be effective.^2,3 However, this type of bandage has several disadvantages including slippage, the loss of sub-bandage pressure over time and daily reapplication.^4,5 While non-cohesive short-stretch bandages warrant daily reapplication, cohesive two-component systems can be changed twice weekly making this treatment option less time-consuming for both patients and health care workers involved in the treatment of chronic edema.^6,7

Although two-component systems were initially developed for the treatment of venous ulcers, they are effective in the treatment of chronic edema as well.^6–12 The two-component compression systems combine a comfort layer and a compression layer.^9,10 As one or both layers of the compression system are cohesive, an advantage of these systems compared to traditional (non-cohesive) short stretch bandages is the fact that they have less slippage and are presumed to maintain pressure for a longer period of time.

Nevertheless, the drop in sub-bandage pressure is a general problem for most types of compression therapy including the two-component cohesive compression systems.^4,5 One potential possible solution for this vast drop in sub-bandage pressure after the application of the bandage, is the addition of a semi-circular layer of the compression material to the ventral aspect of the lower leg. Therefore, the primary objective is to assess the feasibility of increasing sub-bandage pressure through the addition of a partial compression layer. Should this hypothesis be confirmed, future research efforts should concentrate on investigating the efficacy of this approach in patients with chronic edema. This may result in an intensified therapeutic regimen, potentially leading to a reduction in the duration of the intensive treatment phase.

In addition to sub-bandage pressure, the stiffness of the compression system is a crucial element in the management of chronic edema. Higher stiffness has been associated with a greater reduction in edema volume in patients with chronic edema.¹ Furthermore, the technique, level of training and/or experience of the therapist may exert an influence on the treatment effect, as well as the final sub-bandage pressure and stiffness of the bandage.^13,14 Consequently, the application performed by unexperienced trainees in bandaging could result in a less favorable outcome.

The objective of this study is to investigate the effect of an additional partial compression layer on the pressure curves, static stiffness and dynamic stiffness values of two distinct two-component compression systems, Coban (3M) and CoFlex TLC (Milliken Healthcare), which are utilized for the treatment of chronic edema. Furthermore, this study aims to elucidate the discrepancies in pressure and stiffness between these two different types of cohesive two-component compression systems and between the application conducted by a trainee versus an expert on healthy volunteers.

Methods

This study was approved by the ethics committee of the Antwerp University Hospital (Belgium, Registration No. B3002021000231). The research was conducted in accordance with the Declaration of Helsinki and written informed consent was required for all the enrolled participants prior to the participation. Moreover, the STROBE (strengthening the reporting of observational studies in epidemiology) reporting guideline was followed for this cross-sectional study.^15,16 The research was performed at the University of Antwerp.

Selection and description of participants

The participants were recruited between October 2022 and December 2023 through advertisements on social media and by word-of-mouth referrals. In Table 1 the eligibility criteria are listed for the healthy volunteers to participate in this study. Each enrolled participant was scheduled for a single laboratory appointment lasting approximately three hours. During this appointment, the pressure characteristics of the two-component compression systems provided by 3M (Coban) or Milliken Healthcare (CoFlex) were assessed.

Table 1.

Eligibility criteria.

Inclusion criteria	Exclusion criteria
Adult participants aged older than 18 years	Participants aged <18 years and >65 years
Healthy male or female	Lymphatic diseases affecting the lower extremities (e.g. chronic edema)
Ability to read and understand the Dutch language	Sensory deficits, skin lesions, or open wounds on the lower leg at the moment of the study
Providing written informed consent	Kidney, thyroid gland and cardiovascular diseases
	Comorbidities such as: neuropathies, venous ulcers, lipedema, acute infections, history of cancer or active cancer
	Inability to complete the informed consent form due to physical or mental incapacity

Selection and description of physiotherapists

A total of seven physiotherapists participated in the bandaging of the lower legs. Of these, five were unexperienced master students (trainees), while the remaining two (N.G. and S.M.) were expert physical therapists. The group of trainees received approximately eight hours of instruction in the practical application of compression therapy.

Procedure for data collection and measurements

First, the eligibility criteria were checked (Table 1), and the volunteers provided written consent after reading the information brochure. After the participant was officially enrolled in the study, various demographic data (e.g. age, sex, height and weight) were questioned. Subsequently, the circumference of the lower legs was measured at 10 cm and 25 cm proximal to the medial malleolus of the tibia using a measuring tape. Two sensors (PicoPress®; Microlab, Italy) were then attached to each lower limb at 10 cm and 25 cm proximal to the medial malleolus in order to assess the pressure exerted by the two-component compression systems.

Thereafter, the two-component compression system (Coban or CoFlex) was applied to the lower legs from the dorsum of the foot to the tuberositas tibiae (below the knee application) in accordance with the manufacturer’s instructions. Although both bandages have a width of 10 cm and are latex-free to reduce skin irritation, the CoFlex bandage has only one cohesive layer. In contrast, Coban has a cohesive comfort and compression layer. The therapist aimed to apply a sub-bandage pressure of 50-70 mmHg in supine position. The application of a Coban and a CoFlex bandage was alternated between each participant, ensuring that both legs were wrapped with the same type. Once the type of bandage had been determined, one leg was randomly assigned to an expert, while the other was bandaged by a trainee when both were present. Following the application of the sensors and bandage, the baseline measurements were taken.

The baseline measurements consisted of assessing sub-bandage pressure in three distinct positions, as displayed in Figure 1. This procedure was repeated after one and two hours of walking, as well as following the application of an additional partial compression layer.

Figure 1.

Measurement procedure of the sub-bandage pressure of the lower leg in three distinct positions.

The additional partial compression layer is composed of strips of the material of the compression layer, applied in a semi-circular manner along the ventral aspect of the lower leg to ensure that it does not overlap the dorsal part of the lower limb, extending from the foot to the proximal border of the bandage (see Figure 2).The application of the additional partial compression layer was performed by the original therapist, who had previously applied the initial compression layer. The application of this additional layer is executed two hours subsequent to the initial application of the two-component compression system. Furthermore, the pressure and stiffness values of the system following the application of the additional partial compression layer will be graphically represented as the fourth time point on the graphs described as “Additional layer”.

Figure 2.

Application of the additional partial compression layer.

The data obtained during the four different assessment periods enabled us to create pressure curves and calculate the static and dynamic stiffness index (SSI and DSI). Pressure curves were plotted by using the pressure measured in the supine position. The SSI is defined as the difference in pressure in a supine position and the pressure in a standing position.¹⁷ The DSI was calculated by subtracting the minimum pressure from the maximum pressure during a tiptoe exercise.

Statistics

The data of each participant was pseudonymized and processed in a code table in Excel. All statistical analyses were conducted using JMP Pro 17. Descriptive statistics for variables at the ratio level are presented as mean ± standard deviation (SD), whereas categorical variables are presented as number and proportion (%). The statistical analyses were conducted with a significance level of 5%. The primary outcomes of interest are pressure curves and stiffness values. A mixed model analysis was conducted on both variables, assuming a normal distribution and homoscedasticity. In this model, the random effect was the leg of the participant. This is a dependent variable, as the data regarding the pressure of the bandage was generated at four distinct time points by the same leg. Furthermore, the fixed effects for this model were based on three independent and nominal variables: time (four time points), type of bandage (Coban or CoFlex), type of therapist (expert vs trainee), and their interactions. To address the research questions and generate a significant model comprising the significant fixed effects, the stepwise backward elimination procedure was employed. Additionally, a Tukey test was used for the pairwise comparisons.

Results

Patient characteristics

In total, 19 healthy volunteers were recruited for the study. Demographic data and baseline data of the lower legs of the recruited sample are depicted in Table 2. A total of 22 Coban bandages and 16 CoFlex bandages were applied. In addition, the experts bandaged 17 legs and the trainees 21 legs.

Table 2.

Demographic data and baseline characteristics of the 19 healthy volunteers (N = 38 lower limbs).

Variable	Data	Results
Age, years	Mean (SD)	39.79 (14.47)
Weight, kg	Mean (SD)	75.87 (11.03)
Height, m	Mean (SD)	1.72 (0.08)
BMI, kg/m²	Mean (SD)	25.66 (3.00)
Sex	Male, n (%)	9 (47.4)
Sex	Female, n (%)	10 (52.6)
Mean circumference limb at 10 cm height, cm	Mean (SD)	25.07 (2.10)
Mean circumference limb at 25 cm height, cm	Mean (SD)	36.67 (3.31)

BMI, body-mass index; SD, standard deviation.

Pressure curves

Figure 3(a) and (b) provide an overview of the mean evolution in pressure in a supine position for the Coban and CoFlex applications. The sub-bandage pressure measured at the 10 cm level decreased significantly between the baseline measurement and the subsequent measurements taken at 1 hour and 2 hours post-application (p < .0001). Moreover, the application of an additional partial compression layer of the compression material at the ventral aspect of the lower leg resulted in a significant increase in sub-bandage pressure compared to the pressure observed at 1 hour and 2 hours after application (p < .0001). By applying the additional partial compression layer, the sub-bandage pressure could return to its baseline value (p = .9679). Furthermore, at the level of 25 cm, a notable disparity in sub-bandage pressure was observed across all time points. This indicates that the pressure declined significantly over time (Baseline compared to 1h or 2h: p < .0001 and 1h-2h: p = .0339) and increased significantly following the application of an additional partial compression layer (p < .0001). However, it did not revert to its initial baseline value (p = .0005). Additionally, CoFlex demonstrated significantly lower sub-bandage pressure in comparison with Coban at both measurement levels (10 cm: p = .0295 and 25 cm: p = .0066). Lastly, the interaction between the type of bandage and the time points was found to be statistically significant (p = .0045) at the level of 25 cm. This indicates that the rate of change in sub-bandage pressure differed between the Coban and CoFlex bandages.

Figure 3.

Pressure curves at 10 (a) and 25 (b)-cm levels of the lower leg. Solid black line = Coban; and dotted black line = CoFlex; * denotes the statistically significant difference between the pressure levels exerted by Coban and CoFlex over time.

Stiffness

Both two-component systems had comparable stiffness for the SSI as well as DSI. Figure 4(a) and (b) provide information on the static stiffness at the different time points, at both the 10 cm level (Figure 4(a)) and 25 cm (Figure 4(b)) levels. There were no significant differences in static stiffness between the different measurement moments, with the exception of the notable increase in SSI between the baseline value and the subsequent application of the additional partial compression layer at the 10 cm level (p = .0051).

Figure 4.

Static stiffness index at 10 (a) and 25 (b)-cm levels of the lower leg. * denotes the statistically significant difference between the static stiffness at baseline and after the application of additional partial compression layer.

In Figure 5(a) and (b) the dynamic stiffness at the different time points both at the 10 cm level (Figure 5(a)) and the 25 cm level (Figure 5(b)) are illustrated. At the 10 cm level, the DSI significantly increases between the three different time points and the measurement taken after the additional partial compression layer was applied (Compared to baseline: p = .0002; to 1h: p = .0001; to 2h: p = .0064). The dynamic stiffness also exhibited a statistically significant (p = .0451) increase following the application of the additional partial compression layer when compared to the values observed at 1 hour and 2 hours post-application at the 25 cm level. Nevertheless, no statistically significant difference (p = .9555) was observed between the DSI at baseline and after the application of the additional partial compression layer, suggesting that the DSI can return to its initial value at this level.

Figure 5.

Dynamic stiffness index at 10 (a) and 25 (b)-cm levels of the lower leg. * denotes the statistically significant increase of the dynamic stiffness after the application of the additional partial compression layer.

Trainee vs expert

Our analyses demonstrated that there was no statistically significant difference between the trainees and the experts with regard to both sub-bandage pressure and stiffness.

Discussion

To the best of our knowledge, this is the first study to investigate the effect of the additional partial compression layer on pressure curves and stiffness when applied to the ventral aspect of a bandage in two distinct two-component compression systems intended for the management of chronic edema. Compression therapy represents a crucial treatment modality for reducing edema volume during the initial treatment phase.¹⁸ Our findings clearly indicate that the application of additional strips of the compression material to the ventral side of the lower leg after two hours has a beneficial impact on the pressure curves for both systems. The observed variation in sub-bandage pressure among the participants may be partially attributed to the two primary determinants of pressure generation: applied force and contact surface area. Although the tension applied during bandage placement was standardized according to the manufacturer’s guidelines, individual differences in limb circumference result in varying surface areas, which in turn influence pressure distribution – smaller surface areas typically yield higher pressures.¹⁹ Moreover, minor inconsistencies in the application technique, which consequently result in variations in force exerted by different therapists, may have been a contributing factor to the observed variability, despite strict adherence to the manual. These factors underscore the complexity of achieving consistent sub-bandage pressure and emphasize the necessity of considering both anatomical and practitioner-related variables when interpreting results.²⁰ No adverse events, such as skin abrasions, were reported in this study. Furthermore, following the application of the additional partial compression layer, the mean sub-bandage pressure of both types of bandages did not exceed the upper limit of 50-70 mmHg on the lower extremity.²¹

In addition to sub-bandage pressure, another crucial element in bandaging is stiffness.^22,23 Stiffness of the bandage positively correlates with the pressure fluctuations during muscle activity or circumference alterations. The SSI is a relevant parameter because it provides insights into the compression pressure in the upright position, which is clinically more relevant than the pressure in a supine position alone.²² The SSI at the level of 25 cm did not significantly change between the different time points, while at the level of 10 cm the SSI significantly improved with the addition of the partial compression layer. Moreover, the DSI improved due to the additional partial compression layer.

Today, multiple two-component compression systems are available to treat patients. The objective of this study was to investigate the pressure curves, static and dynamic stiffness of Coban (3M) and CoFlex TLC (Milliken Healthcare). While both systems are similarly applied, the distinction lies in the composition of the bandage. In contrast to CoFlex, which comprises a non-cohesive comfort layer and a cohesive compression layer, Coban employs a cohesive comfort and compression layer. This discrepancy may account for the elevated sub-bandage pressure observed for Coban relative to CoFlex in our findings. This finding confirms the results of prior research conducted by Gebruers et al., which demonstrated that CoFlex generates a significantly lower sub-bandage pressure than Coban.⁵

In this study we could not demonstrate significant differences in sub-bandage pressure and stiffness based on the experience of the therapist. Although not statistically significant, the data indicated that the resting pressure generated by the trainees was, on average, slightly higher than that of the bandages applied by the experts. However, this finding was not reflected in the DSI values, which exhibited a tendency to be the opposite. Nevertheless, the DSI is an important variable that determines the effectiveness of the patient’s treatment. Less experienced therapists should be aware that they tend to have higher resting pressure and that these higher pressures do not necessarily result in a higher working pressure. It is also important to note that higher resting pressures in combination with greater elasticity are often reported as a source of discomfort for patients.⁵ The systems in question could be applied twice a week, which underscores the importance of ensuring the comfort of the bandage to prevent the patient from removing it sooner. Furthermore, the two-component compression systems utilized in this study feature aids that assist the therapist in applying the appropriate tension of the bandage. Consequently, we hypothesize that these discrepancies between trainees and experts may be more pronounced in the application of short-stretch bandages. It has been demonstrated that only a minority of healthcare providers possess the necessary skills to apply short-stretch compression bandages with the intended pressure.²⁴

A limitation of this study is the sample of healthy volunteers. In chronic edema the swelling of the limbs will be more pronounced. Consequently, the compression therapy will decrease the volume in the leg, which will then lead to a rapid decrease in sub-bandage pressure.⁴ Nevertheless, we deliberately selected a sample of healthy volunteers, as the application of additional strips had not yet been investigated. Therefore, it was not known with certainty how much the sub-bandage pressure would increase. Furthermore, the additional partial compression layer was only applied to the ventral aspect of the lower leg. It may be beneficial to consider the application of an additional partial compression layer on the dorsal side of the leg, specifically on the calf muscle, to potentially achieve more favorable outcomes with regard to sub-bandage pressure and stiffness. Nevertheless, we elected to implement the procedure solely on the ventral side, given the potential for the patient to apply these strips independently. The ability of the patient to independently control the sub-bandage pressure allows for self-management of the compression treatment and the potential for increased efficacy. The possibility of self-administration of the ventral layers with minimal instruction allows for a more time-efficient and potentially cost-effective treatment, as the initial phase is reduced in length.

Another limitation of this study is that the bandages were only applied to the lower leg. Therefore, we have no information on the application of the cohesive two-component compression systems on the entire lower limb. It is hypothesized that the additional partial compression layer on the upper leg will also have a beneficial effect. However, it is possible that the effect on sub-bandage pressure may be less pronounced with increasing circumference of the lower limb. In many cases, chronic edema is also limited to the feet and/or lower leg. As a result, the information presented in this study is clinically applicable. Lastly, the time of day at which the study protocol was performed differed between participants. While some participants completed the protocol in the morning, others did so in the evening. This variation may influence the results, as swelling tends to be more pronounced at noon compared to the morning.²⁵ Despite this issue being acknowledged beforehand, the timing of the measurements was determined based on the availability of participants and the logistical constraints of coordinating testing sessions.

In conclusion, the application of an additional partial compression layer at the ventral aspect of the lower leg two hours after the application of the two-component compression systems appears to have significant potential to enhance the effectiveness of chronic edema patients’ treatment by positively influencing sub-bandage pressure and stiffness. Furthermore, CoFlex exerts systematically lower pressure levels in comparison with Coban, which could be advantageous in patients with peripheral artery disease. However, no significant differences in stiffness were found between these two systems. Finally, the lack of differences between the application performed by a trainee or expert indicates that both Coban and CoFlex are suitable forms of compression therapy for less experienced therapists to achieve an effective compression treatment.

Footnotes

Authors’ note

T.D.V. is research fellow of the Research Foundation Flanders (FWO) (grant number 1298022N).

Acknowledgements

The authors would like to acknowledge the contributions of the three master’s students in physical therapy (M.A., E.E., P.S.), who were also responsible for gathering the data required for the pressure and stiffness values. The time spent on this project by the authors, as well as the necessary materials, were provided by the University of Antwerp and MOVANT.

Author contributions

All authors (S.M., T.D.V., E.F., L.D., H.V., J.M., U.V.D. and N.G.) contributed to conceptualizing the study, providing feedback on all analyses performed, and writing the manuscript. Moreover, N.G. was involved in protocol development, gaining ethical approval and data collection. The data collection was also supported by S.M. and she wrote the first draft of the manuscript. Furthermore, E.F., S.M. and N.G. were involved in the statistical analyses. All authors (S.M., T.D.V., E.F., L.D., H.V., J.M., U.V.D. and N.G.) reviewed and edited the manuscript and approved the final version of the manuscript.

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) received no financial support for the research, authorship, and/or publication of this article.

Guarantor

Nick Gebruers (N.G.)

Ethical statement

ORCID iDs

Sarah Moonen

Tessa De Vrieze

Erik Fransen

Lot Demuynck

Hanne Verbelen

Jill Meirte

Ulrike Van Daele

Nick Gebruers

Data Availability Statement

The data is available on request to the corresponding author.*

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