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136 T. K. Biswas et al.
Traditional Chinese Medicine (TCM) is presently playing a leading role for the
management of different conditions: in China doctors in TCM and Western systems
work closely together. A most important achievement of TCM is the discovery of
drug Artemisinin from the plant Artemisia annua (Compositae) for the management
of malaria caused by Plasmodium falciparum (Valavanidis 2019). Artemisinin is
key in the combined therapy used to treat malaria today and this success is very
encouraging to wound healers.
There are some selective medicinal plants scientifically screened as wound
healing and wound dressing drugs in TCM though data from controlled studies was
not found in English language databases. It has been argued that TCM interventions
are complex which makes it difficult to test its efficacy using standardised RCT
models (Sun et al. 2021). In this way, it differs from the products used in Western or
Allopathic medicine. The possibilities of publications in Chinese language were not
checked by the authors of this chapter on account of language difficulties.
Discussion
The aim of this chapter was to review data from controlled studies to better
understand the wound healing potential of some medicinal plants and products
simply because plants and related products have evolved over the millennia. During
this period, plants have survived harsh climatic changes and other environmental
insults: it is likely the survivors have had encoded means of combating inflammation and infection, and this could be expressed in the bark, leaves, fruits, or pods.
Many plants have mention in Ayurveda, TCM and other Traditional Systems of
Medicine. The purpose of this book is to exami ne the benefits of evidence and
technology in chronic wound management: this chapter was focused on published
data from controlled studies: a select few plants and products’ efficacy was studied
from publications.
The results of RCT show the potential of Neem extracts as a wound irrigant, the
banana leaf dressing as a valuable wound cover for superficial burn wounds, honey
as a valuable dressing material, among others. From basic studies on animal
models, the intrinsic properties of Pterocarpus santalinus to control inflammation
and support better tissue growth are evident. This begs the question–how to
complete the steps from the bench to the bedside with such a product? Existing
products such as the Banana Leaf Dressing are effective, safe, and commercially
low cost. There is a marked absence of the evidence of adverse events also. It also
needs mention that where efficacy has been demonstrated controlled studies,
specific component or components acting favour ably have not been identified. Is
this a limitation? Only carefully designed studies with sample sizes large enough
would be able to address this question.
Medicinal Plants and Products from Traditional Medicine … 137
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This chapter (and indeed this book) were planned as we emerged from the
shadow of COVID-19. One of the lessons learnt from COVID-19 has surely got to
be an increased willingness to change: the offer of potentially valuable dressings,
oils, ointments, and medication for systemic use with origins in plants have been
described and are offered to the wound healing community.
Acknowledgements Authors are thankful to Dr. Sayan Halder, BAMS for providing original
photograph of Banana tree (Musa paradisiaca), Aloe vera and Centella asiatica.
Conflict of interest None
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Innovation in Laboratory Evaluations
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of the Performance of Treatment
and Prophylactic Dressings Under
Clinically-Relevant Usage Conditions
Amit Gefen
Abstract
The effectiveness of wound dressing performance in exudate management when
applied to treatment, and in redistribution of skin loads when used prophylac-
tically, are commonly and typicall y gauged in simple, non-realistic laboratory
setups, such as where dressing specimens are submersed in vessels containing
aqueous solutions to evaluate their absorbency, or by means of interface pressure
measurements in the context of pressure ulcer/injury prevention. In the last
several years, we have developed a portfolio of clinically-relevant laboratory test
configurations for dressings used in treatment and preventative applications. In
the context of treatment, we developed laboratory test methods and robotic
wound systems for evalua ting two key fluid–structure interaction concepts:
Sorptivity−the ability of wound dressings to transfer exudate, including viscous
fluids, away from the wound-bed by capillary action; and Durability−the
capacity of dressings to maintain their structural integrity over time and
particularly, at removal events. In the prevention arena, we developed
sophisticated, anatomically-accurate computational models of parts of the
human body to evaluate the biomechanical protective efficacy of dressings in
redistributing and alleviating skin and subdermal tissue loads due to bodyweight
or medical device-related forces. This chapter reviews our recent published
research concerning the development of these testing methods for wound
dressings, focusing on the clinical relevance of the tests as well as on the
standardization and automation of the laboratory measurements of dressing
performance. The chapter further demonstrates differences across product
A. Gefen (&)
Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel
Aviv-Yafo, Israel
e-mail: gefen@tauex.tau.ac.il
R. Mani (ed.), Chronic Wound Management,
https://doi.org/10.1007/978-3-031-26110-7_8
141© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
142 A. Gefen
performance metrics detected by means of the above advanced test methods for
products that supposedly belong to the same families, and how these differences
relate to the materials, structure and composition of the tested dressings.
Keywords
Wound dressingsChronic and acute woundsBioengineering laboratory test
methods
Exudate managementPerformance metrics
Introduction
Wounds of all types affect millions of people globally and are a financial burden on
healthcare systems, costing tens of billions of dollars annually (Guest et al., 2020).
The prevalence of chronic wounds, for example, is relatively high and similar to
that of heart failure, affecting 6.5 million people in the United States, which equates
to 2% of the US population (Fife et al., 2012). In addition, chronic wounds account
for 3−6% of total healthcare expenditure in developed countries, and conser vative
estimates for the US point to an associated cost of $28 billion per year to the
American Medicare system (Nussbaum et al., 2018).
Wound dressings remain the primary means for treating wounds and are the
oldest medical device in history, and since ancient times have been used for protecting the wound and absorbing wound fluids. However, the ability of dressings to
effectively protect a wound−not only mechanically but also from biological hazards, and to not merely absorb exudates but retain them so that they are not returned
into the wound and potentially deteriorate it−only developed after the 2nd World
War with the invention of polyurethane foams and later on, silicone-foam composites and superabsorbent materials (Gefen, 2020). One of the primary roles of a
modern wound dressing is to manage exudate, a serum-based fluid that is secreted
from a wound as part of the inflammatory process. Exudate contains proteins,
nutrients, inflammatory mediators, digestive enzymes, growth factors, waste
products, cells (e.g., neutrophils and macrophages) and platelets, and sometimes
also bacteria. The exact composition of exudate and its biochemical and biophysical
properties (such as the pH, viscosity etc.) depend on the wound aetiology, the health
and infection status of the patient and the stage of wound healing (Gefen and
Ousey, 2020; Gefen and Santamaria, 2021).
In general, wounds must be kept moist,
times, as
a standard of care delivered by any modern wound care device (Gefen,
2020). The well-established theory and practice of moist wound healing states that
1
i.e., not too wet and not too dry at all
1
It should be noted that some wounds will bene fit from being kept dry, e.g., chronic ulcers with
necrotic tissue.
Innovation in Laboratory Evaluations of the Performance … 143
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moisture in wounds is critical for preventing the wound from drying out; for
supporting migration of tissue-repairing cells; for diffusing nutrients to cells and
tissues; for diffusing inflammatory mediators such as histamine; for diffusing
growth factors (e.g., for angiogenesis); for trans porting signalling molecules
between cells for cell−cell communication; for allowing immune cell migration to
reduce bacterial burden; and for allowing tissue-repairing cell migration, i.e., of
fibroblasts which synthesise collagen for wound closure.
Excess exudate is known to be harmful to both the wound and the peri-wound
skin (Gefen and Ousey, 2020; Gefen and Santamaria, 2021). Excessive exudate can
degrade the wound via several different damage pathways and multiple damage
routes can apply concurrently. For example, if the woun d is infected, the exudate is
a carrier of pathogens within and outside the wound. If a non-healing wound secrets
excess exudate, nearby skin may be exposed to a high concentration of proteolytic
enzymes (e.g., matrix metalloproteinases) which compromise forming granulation
tissue. Excess exudate can also cause softening and weakening of the peri-wound
stratum corneum and dissolving dermal collagen crosslinks. Decelerated migration
of tissue-repairing cells from the wound edges (e.g., fibroblasts and kerat inocytes)
can also be caused by excessive exudate and the hostile biochemical environment
that it induces for these cells (Tompan et al., 2012). Overall, these issues slow the
rates of wound healing and decrease the extent and rate of woun d closure, or may
even enlarge the wound. In addition to ensuring appropriate moisture balance in the
wound by absorbing and retaining excess exudate, dressings should not disintegrate
and must not leave any microscopic or macroscopic (i.e., visually recognised)
debris in the wound-bed, particularly during dressing changes when the dressing is
subjected to pull-out forces, as this will likely cause chronic inflammation, thereby
critically delaying tissue repair and healing (Gefen and Ousey, 2020; Lustig et al.,
2021b; Gefen et al., 2022a).
In materials science, the structure−function principle is the concept that
microstructure determines properties. For wound dressings, “function” encompasses mechanical, thermal, fluid transport and retention properties, which altogether form a metrics of physical and engineering quantitative performance
parameters. It is important to remember that physical and engineering characteristics of wound dressings belonging to the same family of products, such as
foam-based dressings or gelling fibre dressings, may differ considerably across
manufacturers, and this micro-structure affects the structural, mechanical and
thermal properties and ultimately, the functions and clinical performance of the
dressings. As noted above, evaluating the ability of wound dressings to manage
exudate is of critical importance. However, the effectiveness of wound dressing
performance in exudate management is commonly gauged in simple, non-realistic
laboratory setups rather than by means of clinically-relevant test configurations.
Two key fluid–structure interaction concepts, sorptivity and durability, should be
specifically highlighted in this context. Sorptivity is the ability of wound dressings
to transfer exudate away from the wound-bed, by means of capillary action, even if
144 A. Gefen
the exudate is viscous. Good sorptivity is requi red for transferring exudate from a
primary to a secondary dressing, or from the wound-facing surface of a dressing to
its external surface, from which fluids can evaporate to the environment, and
thereby, clear the dressing reservoir for additional inflowing exudate regardless of
the orientation of the wound and dressing with respect to the gravity vector.
Durability is the capacity of wound dressings to maintain their str
uctural integrity
over time, after exposure to usage conditions, and during removal when pull-out
forces are applied. Both factors, sorptivity and durability, are often ignored in
existing test protocols.
In the prophylaxis of wounds, exudate management is not relevant as the skin is
intact, however, many of the mechanical features that are required for a wound
dressing in a treatment application are also highly relevant and needed in the
context of preventi
on (Gefen, 2021a; 2022b). Focusing now on the prevention of
medical device-rela ted pressure ulcers/injuries (MDRPUs) as a common example,
the most frequently used dressing materials for the prevention of facial MDRPUs
associated with non-invasive ventilation (continuous positive airway pressure,
CPAP) masks are currently hydrocolloid-based and foam-based dressings. The
alleviation of localised and sustained tissue loads is the most fundamental
requirement from any type of dressing in prophylactic use under a CPAP mask, and
avoiding sharp stiffness gradients between the skin and the protecting dressing
serves this purpose well (Lustig et al., 2021a)
. T
he compressive stiffness of a
dressing used for prophylaxis and the compressive stiffness of the skin region
covered by the dressing are therefore the most important and relevant properties to
consider in this regard, given the common techniques of the CPAP device
attachment to skin which apply localised, intense compressive forces to the skin
while strapping the mask to the head (Gefen, 2021a). Based on the above criterion,
hydrocolloid-based dressings which are relatively stiff exhibit poor biomechanical
prophylactic efficacy in protecting healthy skin, and more so, in preventing injuries
in fragile or aged skin. Foam-based dressings, on the other hand, typically have
stiffness properties that closely resemble those of human skin, and, though foam
dressings by different manufacturers vary in their specific stiffness properties, some
low-stiffness foams provide a near-ideal stiffness matching with skin (Gefen,
2021b)
.
hapter reviews our recent published research concerning the development
This c
of testing methods for wound dressings used in both treatment and prevention
applications, focusing on the clinical relevance of the tests as well as on the
standardisati
on and automation of the laboratory measurements of dressing performance. The chapter further demonstrates differences across product performance
metrics detected by means of the above advanced test methods, for products that
supposedly belong to the same families, and explains how these differences relate to
the materials, structure and composition of the tested dressings.
Innovation in Laboratory Evaluations of the Performance … 145
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Robotic Wound Systems Designed and Built
for the Evaluation of Treatment Dressings
Robotic, computerised phantoms of a sacral pressure ulcer/injury (PU/PI), a
non-offloaded diabetic foot ulcer (DFU) and other complex wounds simulating,
e.g., venous leg ulcers (VLU), were developed and are described in detail in our
published work (Lustig and Gefen, 2022a, 2022b; Orlov et al., 2022) (Fig. 1).
These novel experimental platforms, which robustly simulate common wound
aetiologies, facilitate methodological studies of wound dressing performance metrics under clinically-relevant scenarios, including with regards to patient positioning
and the pract ice of application and removal of the dressings under investigation.
These tests further allow evaluations of the function of primary and secondary
dressing combinations, according to typical usage practice.
Fig. 1 Different robotic wound systems representing a variety of wound aetiologies, namely, a
sacral pressure ulcer/injury (PU/PI), a diabetic foot ulcer (DFU) and a venous leg ulcer (VLU). The
latter simulated wound system was built in replicates to allow simultaneous testing of the same
wound dressing type or of different dressing products for high statistical power
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