CEDT Journal

Figure 12: Bar chart representing the amount of slough, granulation tissue and epithelial tissue relative to the wound area. Measurements taken at initial examination and final examination [39-41].

The mean proportion of wound area covered with slow fell significantly (63% → 34%) (Figure 12) and significant increases were documented in the mean area of granulation and epithelial tissue. Additionally, 5 wounds completely re-epithelialized. Since epithelialisation is the defining parameter of a successful wound closure, it clearly proves the hydrogels wound healing capabilities, though, only 5 out of the 81 wounds achieved this [42].

The percentage of wounds not exudating increased from 0% at baseline evaluation to 22%, and the percentage of moderately and heavily exudating wounds fell from 37% to 23% [39]. This is beneficial as when high levels of exudate are not properly managed, the wound bed will become over-hydrated, leaving it more prone to damage [41].

Regarding the more subjective assessments, the ratings aligned with those of the Activheal hydrogel study. Hydrating characteristics and ease of removal were generally regarded as ‘good’ or ‘very good’. The investigating physicians also had a ‘good’ overall impression in 83% of cases [41].

Hydrocolloid (Comfeel Plus)

Hydrocolloid dressings are made up of hydrophilic, self-adhesive colloid granules coated with an external polyurethane film (PU). The external film serves as a form of mechanical protection from environmental factors, while the colloid granules absorb exudate from the wound. Granules utilised in hydrocolloid dressing typically consist of gelatine, pectin and carboxymethyl cellulose (CMC). The granules and PU film can be modified to produce dressings of various size, shapes, and thicknesses [28]. The biocompatibility of hydrocolloid dressings makes them suitable for surface ulcers, such as minor burns, shock injuries, and bruises. However, they are not suitable for deeper/chronic wounds, especially those with infections, as no oxygen is supplied to the wound due to the adhesive, thus the healing process is compromised [25].

Figure 13: Schematic of the dual-layered structure of a hydrocolloid [28].

An article by Goodhead, 2002 published in the British Journal of Nursing sought to evaluate the NHS hydrocolloid dressing of choice, Comfeel Plus Transparent [30,31]. Comfeel Plus is a thin hydrocolloid dressing composed of a 25 µm outer semipermeable polyurethane membrane with a thin 300 µm absorbent and adhesive hydrocolloid interface. The study used 3 patients to evaluate the dressing, with 4 wounds in total. The healing time of each wound was also recorded:

Table 5: Table of all wound types used [30].

It was reported that healthcare staff found the dressing easy to apply and remove. Additionally, another thin hydrocolloid dressing had been evaluated before comfeel, however, its use had resulted in issues like wrinkling and rolling at the edges. No such issues were reported when evaluating the Comfeel Plus transparent hydrocolloid dressing. There was also no odour reported on dressing removal and all the wounds had low exudate levels [30].

Whilst there is a very little evidence to disprove the efficacy of the Comfeel hydrocolloid, the study lacks diversity as the there was a total of 3 patients with 4 wounds total, meaning a broader analysis may produce different. In conjunction with this, a case study by Grange-Prunier et al. 2002 found that a 66-year-old women treated for a leg ulcer with the dressing developed pruriginous, erythematous, and vesiculous dermatitis under the hydrocolloid dressing [32]. The case study does present the findings that allergic contact dermatitis is a possible side-effect of Comfeel plus hydrocolloid dressings, so there may be issues surrounding biocompatibility. Regarding price, it was recorded by NHS Devon Clinical Effectiveness team, 2019 that the NHS pay approximately £2.66 10x10cm and £5.70 for, 15cm x 15cm [43-46, 33].

Handheld electrospinning for wound care

Polymers used for handheld electrospinning

Before addressing the feasibility of handheld ES devices in wound care, it is important to understand structure and characteristics of an electrospun wound dressing. Electrospun dressings are the product of ultra-fine nanofibers in a non-woven, randomly arranged structure [47]. Since ES is in an incredibly versatile technique, with capability of producing fibres with diameters anywhere between 50 nm and 5 μm [48], the diameter and morphology of electrospun fibres are dependent on several parameters, including:

• The type of polymer used.
• Polymer viscosity. 
• Polymer elasticity.
• Polymer concentration.
• Operational conditions of the device: feeding rate, distance from the tip of the device to the wound area and the strength of the applied electrical field [47].
• Humidity and temperature of the environment.

Currently, there are hundreds of polymers which have been successfully electrospun for wound dressing purposes. This includes both natural and synthetic polymers, with each of these types presenting both advantages and drawbacks [49].

Natural polymers have excellent biocompatibility with human tissue as well as low toxicity and biodegradable properties. Some can contribute to tissue repair as they exhibit antimicrobial and anti-inflammatory properties which allow the wound to surpass the chronic inflammatory stage, a place where current dressings tend to fail [50]. Natural polymers commonly used (Figure 14) in electrospinning include collagen, gelatine, alginate, and cellulose [49,50].

Figure 14: Scanning Electron microscope (SEM) images of electrospun: a: collagen [51], b: Fish gelatine, [52] c: Alginate, [53] d: Cellulose [54].

While natural polymers present many advantages for wound care, they are generally less cost-effective when compared to their synthetic counterparts. Additionally, they lack the mechanical strength of synthetic polymers and are more difficult to process [50]. When considering whether they would be worthy of replacing current NHS wound dressing, while they do offer great benefits in terms of biocompatibility and biodegradability, the extra cost associated with natural polymers would likely make them prohibitively expensive.

As mentioned, synthetic polymers are more cost effective than natural polymers due to the simplified processing and production [50]. As a result of the lower costs associated with synthetic polymers, there is far more extensive research on their use in wound dressings [49], making it a good starting point to evaluate what polymers would work in the handheld ES format. They also have outstanding thermal stability and mechanical properties which offer better supports for cell adhesion and proliferation of the wound [49,55]. The main advantage of synthetic polymers is they offer controllable characteristics, which include surface characteristics, hydrophilicity, permeability, and deformability which can be altered and optimised for wound care [55]. Commonly used polymers (Figure 15) include polyvinylpyrrolidone (PVP), Polycaprolactone (PCL), Poly(DL-lactic acid) (PDLLA) and poly(lacto-co-glycolic acid) (PLGA) [49].

Figure 15: Scanning Electron microscope images of electrospun: a: PVP, [56], b: PCL [57],  c : PDLLA, [47] d :PLGA. [58].

Performance of handheld electrospinning

Several in vivo studies have taken place to assess the efficacy of handheld ES and determine whether it is a viable solution to issues surrounding chronic wound care. A study conducted by Xu et al., 2022 sought to address the issue of full-thickness skin wounds, a type of wound that extends beyond the dermis and epidermis, using handheld ES [59]. Their approach was to use the synthetic polymer, polyvinyl alcohol (PVA) in combination with bonemarrow derived stem cells (BMSCs) on 10 rats aged 2-3 months. Three groups of mice were assessed: a PVA/BMSC group, a PVA only group, and a control group (Figure 16).

Figure 16: The progression of wound healing over 14 days in the PVA/BMSC group (top), the PVA only group (middle) and the control group (bottom) [59].

The visual results show wound closure time in the PVA/BMSC group was significantly shorter than the PVA and control group. One of handheld ES advantages over the current NHS dressings is its ability to incorporate cells into the polymeric solution. In this case, the use of BMSCs shortened repair time and promoted wound healing, while the PVA provided structural integrity and firmly attached to the skin surface without the use of adhesives [59]. One consideration for this cell/polymer mix is the voltage applied. Since an electric field that exceeds 0.1kV/mm can reduce cell viability, the handheld apparatus can only be operated within fine voltage parameters as too little voltage will lead to poor microfibre structure, while too much can decrease cell viability [60].

While this in vivo preclinical study included the relevant controls, the sample (N) number of wounds treated is relatively low and only one type of synthetic polymer was used for treatment, meaning conclusions cannot be drawn on whether this polymer is the most optimal for wound care in the handheld ES format. Another in vivo study led by Haik et al., 2017 addresses these shortcomings by using 3 pigs, each with 15 superficial wounds for a total of 45 wounds, substantially more than the previous study.⁷ The wounds had 20 x 20 mm surface areas and depths of 0.254 mm. From a clinical perspective, the use of pigs in this study is beneficial as porcine skin is similar to human skin in terms of immunohistochemical properties and morphological structure [61].

An additional advantage of the latter study [7], was the use 4 different types of polymeric formulations (Figure 17), which tested whether polymer structure was a function in repair. The 4 polymeric solutions are:

A) Biocompatible and biodegradable polyester-based polymer.

B) Biocompatible polycarbonate-based silicone elastomer.

C) Blend of two biocompatible polyurethanes.

D) Blend of biocompatible polyurethane and polyester.

A fifth, commercially available control dressing was used named paraffin nonmedicated gras dressing. It has been concluded in the past that this form of dressing is not statistically different to a hydrocolloid dressing, which is useful for comparative studies [62].

Figure 17: The 4 Electrospun polymer-based dressings (a-d) alongside (e) the control dressing, after application [7].

Wounds were assessed, 2 days, 7 days, and 14 days after application on various metrics:

• Adherence
• Wound exudate
• Presence of eschar
• Any adverse skin reactions: erythema and oedema

Conclusions from this study suggest that polymer A (polyesterbased polymer) took only 1 minute to create a dressing of suitable thickness from the hand-held ES device compared to the other polymers which took 2 minutes. This may be a useful consideration for emergency situations. Generally, no significant differences were found between the polymers in all the metrics assessed. However, since the hand-held ES allows for contactless application, risk of infection is significantly reduced since hands are the main source of transferring infections.⁷ Additionally, when the wound is an abnormal shape or is in a challenging area, application of dressing using hand-held ES is easier since the polymer is flexible and easier to work with. While this in vivo study was insightful, the ES dressings could have been randomised on application to reduce risk of bias.

Clinical trials for electrospun dressings

Since handheld ES is still a relatively new concept, as of today, no clinical trials have been conducted to assess the efficacy of these devices against current wound dressing alternatives. With that said, it has been understood for some time now that ES presents great potential for tissue engineering applications [3]. Because of this, clinical trials have taken place to assess the capability of ES produced nanofibers in wound care. Fibres produced using conventional ES techniques, and these clinical studies can be used to gain a further understanding of the potential of handheld ES [11].

Figure 18: SEM images of:  a. PCL and b. PCL/gelatine nanofibers [64].

The mechanical strength of the dressings was assessed using Young’s modulus strength calculations, a property that describes a material’s ability to withstand deformation under stress [65]. The mechanical strength of PCL and PCL/gelatine were 1.43 megapascals (MPa) and 0.86 MPa respectively. While the PCL ES nanofiber is significantly stronger, the PCL/gelatine still outperforms the Young’s modulus of the NHS dressing hydrogel, which is in the range of 10-100 kilopascals (kPA), thus showing the benefits in mechanical strength of ES fibres [66].

The progression in healing of the stage 2 pressure ulcers was assessed using the pressure ulcer scale for healing (PUSH) score, a scale which incorporates wound size, exudate excretion and tissue type, with higher scores indicating deterioration [67].

Figure 19: A comparison of average PUSH scores for each assessment time with us of PCL/gelatine nanofibers [64].

PUSH scores presented a statistically significant (P < 0.05) decline (Figure 19), from 19.48 upon initial assessment, to 4.26 upon final assessment, which shows the PCL/gelatine nanofibers had a therapeutic effect on skin repair. While the PUSH score is widely recognised as the gold standard for pressure injuries and the analysis is this study is comprehensive, the author failed to state the time differences between each analysis of the wound. Despite this shortcoming, the clinical trial was able to show the benefits of a synthetic/natural ES polymeric blend. The PCL/gelatine was able to promote wound closure, collagen generation, re-epithelization, and angiogenesis [64]. Though it clearly demonstrates the benefits of ES, it would have been useful to add another group of participants who used only the PCL as a dressing. This would clearly convey the benefits of natural polymers. Also, comparisons to a current wound dressing alternative by making the study a randomized control trial (RCT) would have been insightful to give a clearer idea of the true benefits of ES produced nanofibers.

A retrospective case series conducted by Regulski & MacEwan, 2018, looked to address the limitations of current wound dressing alternatives by using ES produced synthetic fibre matrix [6568]. Participants included patients with chronic wound that had remained unhealed for ≥ 4 weeks and had been unresponsive to existing alternative, which came to 82 total patients (Table 6). These wound included diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) which are notoriously difficult to treat. Wounds received a layer of synthetic fibre matrix weekly from one of the physicians, for up to 12 weeks.

Table 6: Patient demographics. DFUs: Diabetic foot ulcers; VLUs: Venous leg ulcers [68].

Significant wound healing was observed throughout the study (P < 0.05), with 85% (68) of the wound achieving complete closure at 12 weeks. Notably, 91% (30) of VLUs achieved complete closure after 12 weeks. This case series was able to successfully prove the potential of ES produced nanofibers in dealing with unhealed, chronic wounds. Since the majority of NHS spending is on unhealed chronic wound, this presents a potential cost-effective solution to this issue [26]. Though this study did not use a RCT format, the reasons are justified since participants had to be selected based on the healing progress of their wounds as their previous dressings/ treatments had not been successful. For this reason, it still effectively demonstrates the efficacy of ES nanofibers compared to other alternatives. In the future, it would be useful to see this study completed over multiple centres rather than just one, in a doubleblinded format to reduce bias. Additionally, there was a failure to mention the type of synthetic material used in the ES production; this information would be useful for further trials and assessments.

Discussion

Performance of current wound dressings

This review aimed to evaluate the potential of handheld ES against current NHS wound dressings by using characteristics of an optimal wound dressing. Two of the most advanced wounds dressings used by the NHS, hydrogel, and hydrocolloids, were included in the analyses [33]. Results from the clinical trials included suggest that both dressing perform well on a variety of wound types. Notably, both maintain good levels of moisture around the wound, which help to facilitate epithelial migration and reduce scar formation [69]. Participants and healthcare professionals also had very little criticism and were overall very satisfied with comfort and ease of application. Though they seem to be affective dressings, they fail to address the main issue of chronic wound healing. Since these dressings lack natural materials and active ingredients, it leads the wound to accumulate excessive levels of pro inflammatory cytokines, leading to elevated levels of proteases, which causes the wound to remain in the chronic inflammatory stage [70]. A deficiency of stem cells means the wound is unable to go beyond the inflammatory stage and transition into the reparative proliferative stage of wound healing.

The issue of wound care and handheld electrospinning’s ability to solve it

The NHS spends approximately £8.3bn annually on wound care. Of this, £2.7bn is spent on the 70% of wound that heal, while £5.6 bn is spent on the 30% of wounds which are chronic [26]. Chronic wounds fail to progress through the normal stages of wound healing and often remain at the chronic inflammatory phase due to an imbalance of cytokines, proteases, and reactive oxygen species (ROS) [70]. With the expected demographic growth of the elder UK population and the current financial strains of the NHS, this current chronic wound care system is unsustainable. 

Handheld ES is an iteration of the of the monoaxial ES technology which allows for portable and direct application of nanofibers [3]. Since these nanofibers can be applied directly onto skin, there has been the question of whether handheld ES can be utilised in wound care. In vivo studies have been carried out in the aid of answering this question. The study completed by Xu et al., 2022 on rat wounds presented a key benefit of handheld ES, being its easily modifiable nature [59]. The addition of BMSCs to the synthetic nanofiber presented significant progression of wound healing compared to the control group. Additionally, BMSCs used in pre-clinical studies have reported dermal rebuilding, reduced inflammation, and growth of fibroblasts in chronic wounds, allowing the wound to surpass the chronic inflammatory stage where current dressings fail [71]. This nanofiber dressing produced by handheld ES has potential to solve the issue of chronic wound healing. Ideally if the study used chronic wounds, while also comparing against a dressing alternative, it would have helped to demonstrate this advantage more clearly.

The latter study of handheld ES by Haik et al., 2017 demonstrated the potential of handheld ES produced nanofibers on human skin, since pig skin is of similar immunohistochemistry to human skin [7,61]. Though the study failed to recognise any clear advantages of the nanofibers over current wound dressings, it did highlight the broader benefits of the handheld devices. The contactless application is significant since some unhealed/chronic wound can be attributed to an uncontrollable infection [70]. In conjunction with this, since handheld ES application is directly onto the wound, they can be tailored to fit the wound perfectly, whilst current dressings often fall short in this regard when the wound is in an obscure location. The portability of handheld ES also means it could be applied in various scenarios like military of paramedic services.

Nanofibers in wound care

The novelty of the handheld ES device means that as of writing this review, no clinical trials have taken place with the device. Though fibres produced by handheld ES are of virtually identical morphology to those produced by other techniques, so clinical trials which used ES produced nanofibers can be used to assess the potential of the handheld device.

Nanofiber dressings have a substantial surface area to volume ratio, as well as high porosity, high levels of tensile strength and, modifiable surface morphology and function [49]. These characteristics allow ES nanofibers to mimic the biological functionality and structure of an ECM. For example, the high porosity allows for movement of water and gases in an out of the covered wound area, allowing for cellular respiration and ensuring the moisture levels are optimal [50].

In terms of providing solutions to the problem of chronic wound healing, the study conducted by Regulski & MacEwan, 2018, proved the efficacy of nanofiber dressings, with 85% of chronic wounds achieving complete closure after 12 weeks [68]. This can be attributed to the characteristics listed above.

Limitations

Limitations of Handheld electrospinning

While handheld ES is a versatile and innovative technique that has great potential to address the issues of current wound care, there are some limitations that must be addressed. The NHS is currently under significant financial strain, so if the handheld devices are not cost effective, they are simply not worth perusing. Though with that said, Brako et al., 2018 was able to assemble a handheld ES device with commercially available parts for approximately £2000, which could be feasible for the NHS since fibres required to produce the dressing are relatively inexpensive [46]. However, it remains to be demonstrated whether this production could be scaled to an organisational level.

Another limitation of the handheld ES device is the possible need for prior training to operate safely. Whilst these devices are generally easier to operate than conventional ES techniques, producing a nanofiber dressing directly onto the wound likely need extensive training and examinations. If the NHS intends to make the handheld ES dressing accessible for all patients, the need for training would be a limiting factor.

Limitations of the literature

Whilst this study successfully outlined numerous advantages of handheld ES compared to conventional dressings, there were some limitations which must be considered. To begin with, as of writing this review, there are no clinical trials taking place for handheld ES devices. A clinical trial would prove the efficacy of handheld ES clearly and there would be no room for dispute. While animal studies are insightful, and the results obtained from them are likely to align with the results from a clinical trial, the true potential of handheld ES cannot be proven until a clinical trial is completed.

In conjunction with this, there is no current literature directly comparing the NHS wound dressings (hydrogel, hydrocolloid) to ES produced nanofibers. While comparative studies have taken place with dressings of similar characteristics, the use of handheld ES in the NHS cannot be justified until it has been compared directly to all dressings in the wound care formulary.

Conclusion

Overall, this study was able to outline the characteristics of an ideal wound dressing and use them to compare the potential of a handheld ES device to current NHS therapies. Multiple advantages of handheld ES and nanofiber dressing were identified over current therapies, and limitations of the device were also acknowledged. From a future perspective, clinical studies must take place with handheld ES devices in a RCT format. It must be compared to all current NHS wound therapies and if handheld ES is deemed to be advantageous, this may mark a new milestone for modern wound care. As of today, there simply isn’t enough evidence to justify the use in the NHS. However, if the clinical trials are completed and it is deemed cost effective to mass produce handheld ES devices, I believe it has the potential to become the new gold standard for chronic wound care in the near future.

Acknowledgments

I would like to show my greatest appreciation to my supervisor, Dr Ilyas Khan. Dr Khan’s continuous support through this project was vital, and without him this project would not have been possible. I would also like to thank Dr Luke Burke. As one of the leading developers of the handheld electrospinning device, he gave me the information and ideas to pursue this project.

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