Volume 45 Number 3
The soluble to the insoluble era: the evolution of hydrocolloid skin barriers through super-absorbent polymers
Adrian P Defante
Keywords classification, ostomy product, hydrocolloid skin barrier, super absorbent polymer
For referencing Defante AP. The soluble to the insoluble era: the evolution of hydrocolloid skin barriers through super-absorbent polymers. WCET® Journal. 2025;45(3)28-36.
DOI 10.33235/wcet.45.3.28-36
Abstract
There are many hydrocolloid skin barriers (HSBs) available to ostomy patients, making it difficult to determine the differences among ostomy products and offerings. The materials that are used to formulate the HSB is one perspective to classify different HSB types. Here, I classify HSBs, (traditional, infused, insoluble), based on their materials. Specifically, I focus on the use of the super absorbent polymer (SAP) in the HSB, by measuring fluid management and durability properties. This was conducted by comparing three different HSB products from two different companies. The results show the differences in performance for two different types of SAP, soluble and insoluble (iSAP). I further show how formulating with an iSAP can be optimised with an additional property, such as pH balancing, to create an HSB formulation defined as an iSAP+.
Abbreviations
CMC – carboxymethylcellulose
FAC – fluid absorption capacity
GATS – gravimetric absorption testing
HSB – hydrocolloid skin barrier
iSAP – insoluble super absorbent polymer
iSAP+ – an HSB formulation comprised of an insoluble, super-absorbing polymer with pH buffering
KOH – potassium hydroxide
MARSI – peristomal medical adhesive-related skin injury
PMASD – peristomal moisture-associated skin damage
PSC – peristomal‑skin complications
SAP – super absorbent polymer
TEWL – transepidermal water loss
Introduction
Living with a stoma presents numerous challenges, and maintaining healthy peristomal skin is among the most critical. Peristomal‑skin complications (PSCs) contribute substantially to discomfort, appliance leakage, and diminished quality of life. Reported PSC incidence ranges from 36% to 73%1 and a 13‑country survey of 4227 people with stomas found that 73% experienced a PSC within six months.2 These data underscore the need for proactive preventive care, timely stoma care nursing support and evidence-based selection of skin barriers.
Two mechanisms drive most PSCs: Peristomal Medical Adhesive-Related Skin Injury (MARSI) and Peristomal Moisture-Associated Skin Damage (PMASD).3,4
MARSI occurs when the adhesive bonds of ostomy products adhere more strongly to the skin than the cohesion of skin cells to one another.3 This can lead to skin stripping, blisters and tears. Repeated removal of skin barriers may strip away microscopic layers of skin, disrupting the stratum corneum and leaving it vulnerable to further damage.
PMASD develops when moisture, whether from perspiration, transepidermal water loss (TEWL), or stoma output (faecal or urinary) comes into contact with the skin.4 The outermost layer of the epidermis, the stratum corneum, maintains an acidic pH of around four, forming an acid mantle that protects skin integrity and defends against bacteria and irritants. However, stoma output is alkaline (pH ~8) and contains digestive enzymes that disrupt this acid mantle, raise skin pH, and damage the epidermis, ultimately leading to PSCs.5
Central to contemporary ostomy care is the evolution of hydrocolloid skin barriers (HSBs) designed to protect and preserve skin integrity. HSBs are formulated for their fluid management and adhesive properties by incorporating hydrocolloids, including, most recently, super-absorbent polymers (SAPs). SAPs are capable of absorbing and retaining significant amounts of fluid. These materials offer enhanced protection against moisture-induced skin damage. By effectively managing excessive moisture and promoting optimal skin hydration, SAP-integrated hydrocolloid barriers promise improved clinical outcomes, reduced incidence of PSCs and enhanced overall patient experience.
The performance of these absorbent materials plays a vital role in managing peristomal skin health. SAPs have been a foundational material used in the formulation of skin hydrocolloid.6,7 These polymers are capable of absorbing large amounts of fluid, 30X to 1000X, relative to their weight. SAPs broadly have the ability to absorb fluid, but there are differences in fluid absorption rate, capacity, and solubility due to SAP type. Taking advantage of these material differences has led to the development of distinct types and generations of HSBs. This paper categorises HSBs according to SAP type origin, capacity and solubility and systematically compares their fluid management, durability and skin health properties. By linking polymer science to clinical performance, we aim to inform evidence-based barrier selection and promote ongoing innovation in ostomy technology.
Materials in hydrocolloid skin barriers
The beginnings of materials solutions for ostomy care
George Deppy, Queen Caroline of Brandenburg-Ansbach, and Margaret White are among the earliest documented individuals to live with a stoma.8 In the absence of specialised products, options for managing stomal output were extremely limited. From the 1700s to the 1940s, people often relied on improvised waste collection devices, such as washcloths, metal containers, bags, or sponges, secured with elastic bands.9-11
One of the first polymeric materials used for skin adherence in ostomy care was gum karaya—a naturally occurring polymer derived from the sap of the Sterculia urens tree. Originally used in denture fixatives, gum karaya was introduced to ostomy care in 1952 by Dr Rupert Turnbull, often regarded as the father of enterostomal therapy.12-14 Turnbull recognised its absorbent properties as beneficial for managing stomal output. However, karaya’s weak skin adhesion required it to be combined with other polymeric materials (CMC), Poly (methyl vinyl ether-co-maleic anhydride), polyisobutylene) to be effective.12
The growing availability of synthetic polymers, driven by mass production in the mid-20th century, enabled the development of more advanced and reliable materials. This innovation marked a turning point in the development of HSBs, explicitly engineered to meet the specific needs of individuals living with a stoma. Some early examples of HSB formulations using synthetic polymers, such as Stomahesive™, appeared in the 1970s.15,16
Figure 1 shows the evolution of ostomy technology. Solutions to manage life with a stoma consisted of do-it-yourself remedies, using available materials not intended for ostomy care. Today, the design of ostomy care technology mostly consists of an HSB and a waste collection system. The application of polymers has fundamentally changed the development of ostomy care technology, enabling scientists and engineers to design materials with intentional functions.

Figure 1. The progression of ostomy care technologies.
Polymers in barrier formulation
The two primary attributes of ostomy barrier performance are adhesion to the skin to support a waste collection system and the management of bodily fluids, specifically absorption. To achieve this performance, HSBs are composed of a mixture of hydrophobic and hydrophilic polymers. Hydrophobic polymers are polymers that have poor affinity for water. They mainly provide adhesion to the skin and durability during wear. Polyisobutylene, styrene block copolymer derivatives, and rubbery polymers are examples of hydrophobic polymers used in the formulation of HSBs.7,17 Hydrophilic polymers are polymers that have a high affinity for water. They give the HSB the ability to absorb stomal output and manage skin moisture. Most polymers used are derived from natural sources, such as tree sap, wood pulp, or fruit peels. Karaya gum, CMC) and pectin are more specific examples of hydrophilic polymers used in HSBs.6,7,17
Super-absorbent polymers
The hydrophilic polymers used in HSBs can also be called super-absorbent polymers (SAPs). SAPs can be categorised by origin, fluid capacity, or solubility. Figure 2 demonstrates the material properties of two SAPs: CMC and sodium polyacrylate, showing they can absorb large amounts of fluid relative to their weight. SAPs in ostomy care can be sourced from natural sources mentioned previously or produced synthetically. Sodium polyacrylate, polyvinyl alcohol, polyvinylpyrrolidone, and ethylene maleic anhydride are examples of synthetic SAPs.18

Figure 2. Fluid absorption capacity measurements showing the uptake behavior of a) Two fluids and b) The summary of fluid capacity for two different polymers.
The two fluids used for testing water and 0.9% saline represent the range of ionic strength or salinity that might be found in stoma effluent.19 CMC absorbs large amounts of water and the type of fluid does not influence its absorption capacity. Sodium polyacrylate absorbs more water compared to saline. This is because the ions in saline can disrupt their ability to bond with water molecules, diminishing their absorption capacity. CMC, therefore, has a lower fluid absorption capacity and range compared to sodium polyacrylate. SAPs can also be categorised by solubility. From these results, SAPs can be characterised by their fluid absorption capacity and versatility.
SAPs can be categorised by their solubility. Solubility is the ability of a polymer to dissolve in a fluid. Soluble SAPs can dissolve, whereas insoluble SAPs (iSAPs) do not. This is due to the chemical crosslinks of iSAPs, which prevent dissolution. Figure 3 shows the visual difference between soluble and insoluble SAPs when dispersed in fluid. The turbidness [e.g. cloudiness or milkiness] of sodium polyacrylate indicates it is an iSAP.

Figure 3. a) Dry and wet form of super absorbing polymers b) Visual representation of dissolution behavior between a soluble and insoluble super absortbing polymer.
In contrast, the clarity of the CMC placed in a fluid indicates that this polymer dissolves in the fluid. Differences in how much fluid these materials absorb and whether they dissolve (solubility) reveal the differences in the performance of super-absorbing polymers. Different types of hydrocolloid skin barriers are formulated based on variations in these material properties, such as absorption capacity and solubility.
Materials and methods
Materials: Three different brands of HSBs were tested: Nova™ and TRE™ (manufactured by Dansac A/S) and SenSura Mio™ (manufactured by Coloplast A/S). To account for performance and manufacturing variability, three production lots of each brand were tested.
The study selected HSBs differentiated by SAP type to compare within a single brand and between two different brands. This allowed for comparison of the same materials, same brand and comparison of same materials for two different brands. This allowed for comparison of two different materials, different brands.
Methods
Gravimetric Absorption Testing (GATS): 50mg of polymer powder was placed on a glass frit. Fluid was passed through the frit from a reservoir connected to a balance. As absorption occurred, changes in the weight of the fluid source were monitored over time to assess the absorption rate.
Surface absorption rate and surface dryness: To measure the rate of fluid absorption, a 100µL droplet of fluid was applied to the adhesive side of a 20mm diameter test disc (the side designed to contact the skin). The barrier’s backing film faced downward on a level surface. The droplet was intentionally larger than the surface area of the disc.
Barriers were weighed with their release liners before fluid application. The release liners were also weighed after removal. Tests were conducted under controlled conditions (temperature: 21–25°C; relative humidity: 30–50%).
An image of the droplet was captured every five minutes for 60 minutes using a JAI Go-5100C camera with a FUJINON HF12.5SA-1 lens. After 60 minutes, Whatman 1 filter paper was placed over the disc to absorb any fluid remaining on the surface of the barrier. A 100-gram weight was placed on top of the filter paper for 60 seconds to ensure consistent pressure was applied.
The droplet height was measured using ImageJ software. The fluid absorption rate was calculated as the percentage change in droplet size over time.
The volume of fluid absorbed into the barrier was calculated as the differential change in the test sample: mabsorbed – mdry – mrelease.
The volume of fluid remaining on the surface was calculated by the differential change in the weight of the filter paper: mabsorbed – mdry.
Fluid Absorption Capacity: Fluid absorption capacity was measured in accordance with ISO 12505-1:2014. In brief, a disc of the test material was weighed before and after exposure to a fluid reservoir. Samples were placed in an environmental chamber set at 37°C for 24 hours to simulate body temperature conditions. After incubation, samples were drained of excess fluid for 15 minutes before their final weight was recorded. The difference in weight before and after exposure represented the material’s fluid absorption capacity.
Swelling ratio: The swelling ratio was determined by measuring the change in the barrier’s height before and after 24 hours of fluid exposure (absorption testing).
Erosion Rate: Erosion rate (mg/hr) was calculated by measuring the rate of weight change of each sample before and after 24 hours of exposure to falling fluid droplets, delivered at a rate of 3.1mL/min. Droplet size was controlled using 22GA blunt-tip nozzles, with flow regulated by constant gravity-driven hydrostatic pressure. The test area had a diameter of 13mm, and barrier thickness varied by manufacturer. All samples were conditioned in a desiccator for a minimum of two hours prior to testing.
pH Titration: A Mettler Toledo T50 titrator with a DGi115-SC electrode was used to measure the acid value. Each 25mm diameter barrier sample was placed in 50mL of 0.9% saline in a beaker. The sample’s initial weight was recorded and entered into the instrument. After equilibrating at 37°C for 24 hours, the solution was titrated with 0.1N potassium hydroxide (KOH) to reach a neutral pH of seven. The titrator recorded the volume of KOH consumed, the acid value (mg KOH/g sample), and the starting pH.
Data Analysis: Data were summarised using standard descriptive statistics for continuous variables (such as means and standard deviations). All graphical error bars represent ±1 standard deviation from the mean. Temporal patterns were evaluated using both linear and sublinear trend analyses, with the latter modeled as a square root function of time, to assess changes over time.
Results and discussion
The core function of a hydrocolloid skin barrier (HSB) is to provide skin adherence and manage fluids. This study specifically focused on fluid management facilitated by the SAPS within the barrier. We did not assess adhesion performance, as hydrophobic polymers primarily impact this aspect. This paper compares fluid management, durability and the potential to support advanced skin health functionality across three hydrocolloid skin adhesives formulated with two different types of SAPs.
Fluid management
Fluid management consists of the ability of an HSB to remove fluid from an interface, such as the skin, and the amount of fluid it can hold.
Figure 4 shows the absorption rate of a fluid droplet on a hydrocolloid barrier over 60 minutes, simulating fluid removal from the skin surface. The absorption patterns differ noticeably between water and saline. To evaluate the rate of absorption, we applied a linear model, with steeper negative slopes indicating faster uptake. To assess the water absorption rate of the TRE barriers, we used a Fickian diffusion model. These results demonstrated that TRE had the highest absorption rate among all tested HSBs and fluids.

Figure 4. a) The absorption behavior of fluid droplets on three different hydrocolloid skin barriers at time 0 minutes and 60 minutes. b) and c) % change of droplet height over time with a summary of the absorption rates. All hydrocolloid skin barriers follow a linear behavior, except for TRE.
Across all three hydrocolloid barriers, water was absorbed more rapidly than saline. This difference can be attributed to saline’s ionic strength, which limits water bonding to the SAP, thereby slowing absorption.20 Among the HSBs, Sensura Mio and Nova exhibited similar rates for both saline and water, whereas the TRE barrier showed a markedly faster uptake of water than saline. This difference suggests that the TRE barrier offers greater versatility in handling fluids of varying ionic strengths, such as those commonly excreted from a stoma, enhancing its ability to remove moisture efficiently from the skin surface.
Figure 5 shows the amount of residual fluid remaining on the surface after 60 minutes of absorption into the hydrocolloid barrier. This complements the absorption rate data presented in Figure 4, as faster fluid uptake is expected to result in less fluid remaining at the skin–barrier interface. Figure 5b confirms that fluid volume was conserved across all tested systems.

Figure 5. a) Dry touch measurements characterising the amount of fluid residing on the surface after 60 minutes. b) Mass balance of unabsorbed and absorbed fluid.
For water, we observed that the TRE barrier absorbs the most, leaving the least residual surface fluid. Nova and Sensura Mio show progressively lower water uptake. For saline, the Nova barrier leaves less fluid on the surface than both the TRE and Sensura Mio barriers. Notably, after 60 minutes, the Sensura Mio barrier absorbs the least amount of both fluids. The dry-to-touch results for the TRE barrier suggest that this HSB effectively removes a broader range of fluids with varying ionic strengths from the skin-barrier interface.
Figure 6 shows the amount of fluid each hydrocolloid barrier absorbed after 24 hours. This test focused on the capacity of fluid absorbed into the barrier when exposed to a saturated fluid environment. Sensura Mio absorbed similar amounts of water and saline, indicating fluid-independent performance. In contrast, both the Nova and TRE barriers show fluid-dependent absorption. Nova absorbed approximately 20% more saline than water, while the TRE barrier absorbed approximately 240% more water than saline. Both Nova and TRE barriers absorbed marginally more saline than the Sensura Mio, but the TRE barrier demonstrated the highest overall water absorption across the tested HSBs.
Figure 6c presents the swelling ratio of each barrier. A swollen barrier provides a physical cue that fluid is being absorbed and retained in the barrier. Sensura Mio and Nova showed similar swelling behaviour in both fluids, aligning with their consistent absorption profiles. The TRE barrier, however, swelled significantly more in both water and saline, reflecting its higher absorption. This pronounced swelling may offer a clearer visual or tactile signal to the end user that the barrier is actively absorbing and managing fluid at the skin surface.

Figure 6 Data for fluid property measurements a) Fluid absorption capacity b) Swelling ratio and c) Relationship between fluid absorption capacity and swelling ratio.
Erosion resistance serves as a quantitative measure of barrier durability and is indicative of wet integrity. The following results highlight how the incorporation of SAPs influences the structural resilience of hydrocolloid barriers under simulated use conditions.
Durability
Figure 7 presents erosion resistance results for each hydrocolloid barrier after 24 hours of exposure. It measures barrier integrity when simultaneously absorbing fluid and undergoing mechanical stress due to the impact of fluid droplets.
While this test simulates a more extreme scenario than typical clinical use, it serves as a proxy for the physical stress that barriers experience during patient movement, particularly when saturated with fluid. Erosion rates are reported in milligrams per hour (mg/h).
Among the barriers tested, the Nova barrier exhibited the highest erosion rates in both water and saline exposure, indicating the lowest resistance to degradation over time. In contrast, TRE and Sensura Mio demonstrated lower erosion rates in water, with similar values for both materials when tested in saline.
The erosion resistance of a hydrocolloid barrier is influenced by its formulation, particularly the balance of water-soluble and water-insoluble components. Water-soluble materials tend to dissolve upon exposure to fluid, thereby reducing barrier integrity. In contrast, insoluble materials, such as hydrophobic polymers, contribute to wet strength by maintaining structural cohesion. A low erosion rate is typically associated with a high proportion of insoluble materials.
The TRE barrier is formulated with an insoluble SAP (iSAP). This unique polymer is capable of absorbing fluid while maintaining integrity. As observed in the previous test methods, the iSAP enables TRE to achieve a balance between high fluid absorption and low erosion—properties that are often mutually exclusive in conventional hydrocolloid barrier systems.
Notably, the erosion rate of the TRE barrier appears elevated in water compared to saline and relative to Sensura Mio. This is due to the high swelling ratio of the TRE barrier in water, which can cause the material to expand and spill into adjacent wells during testing (Figure 7b). While this may affect the precision of the erosion measurement, the test samples remained structurally intact upon removal, suggesting that the TRE barrier retains functional durability under saturated conditions.

Figure 7. a) Erosion rate for three different HSBs, b) Swollen TRE hydrocolloid aggregating into other test sample spaces compared to minimally swollen Nova.
Skin health
The following results demonstrate that an iSAP can be effectively formulated into a hydrocolloid barrier that supports skin health while maintaining fluid management performance and structural durability.
Figure 8 illustrates the acid value, a measure of the hydrocolloid barrier’s buffering capacity. This parameter reflects the ability of the hydrocolloid to help maintain the skin’s acid mantle when exposed to alkaline (caustic) or enzyme-rich stoma effluent.21 Maintaining a slightly acidic pH at the skin surface is critical to preserving skin integrity.
In the visual assessment shown in Figure 8a, each HSB was exposed to a pH-sensitive indicator for 30 minutes. The indicator solution initially appears blue, reflecting an alkaline environment. Over time, the fluid colour shifted to yellow, indicating a more acidic environment. Among the tested barriers, the TRE hydrocolloid produced the most rapid and intense colour change, suggesting a strong buffering response.
To quantify this observation, titration was used to calculate the acid value for each product. Consistent with the visual assessment, Sensura Mio and Nova showed minimal buffering capacity. At the same time, the TRE barrier demonstrated a significantly stronger response, with acid values 4–5 times greater than those of the other barriers.
These findings support that an iSAP can be optimised within a hydrocolloid skin barrier to enhance buffering capacity and promote skin health without compromising fluid absorption or erosion resistance.

Figure 8. a) Visual comparison and b) Quantitative measurements demonstrating pH buffering capacity.
Impact of super absorbing polymer technology on hydrocolloid skin barrier development
Figure 9 highlights the evolution of hydrocolloid skin barrier technology, tracing the development of fluid management performance from early karaya-based materials to the integration of modern SAPs. Traditional HSBs were primarily designed to absorb moisture and protect the peristomal skin from effluent, forming the foundational function that defines all subsequent HSB development. Contemporary products such as Sensura Mio, Nova, and TRE barriers exemplify this baseline requirement for fluid handling.

Figure 9. Evolution of the application of SAP technology segmented by super-absorbing polymer type and hydrocolloid skin formulation.
Building on this framework, newer-generation HSBs have introduced enhancements by combining SAPs with ingredients that support skin health. Further differentiation arises from the specific type of SAP used. For example, the iSAP incorporated into the TRE barrier offers broader versatility in fluid management, enabling faster dry-to-touch performance and effective absorption across a range of fluid ionic strengths—capabilities not as prominently observed in Sensura Mio or Nova barriers. Notably, these advantages emerge despite all three products demonstrating comparable total fluid absorption capacity.
An iSAP also contributes to mechanical durability through the polymer crosslinking process. However, durability can also be influenced by the overall formulation, as evidenced by the superior erosion resistance of the Sensura Mio barrier compared to Nova, despite both using conventional SAPs.
Finally, the TRE barrier formulation demonstrates how iSAP-based fluid handling can be integrated with additional functional benefits, such as pH-buffering technology, to support skin health—an HSB formulation comprised of an insoluble, super-absorbing polymer with pH buffering (iSAP+). This added feature distinguishes the TRE barrier from the other barriers tested, marking a significant step forward in the multi-functional design of modern hydrocolloid skin barriers.
Conclusions
Super-absorbent polymers (SAPs) have played a foundational role in the development of hydrocolloid skin barriers (HSBs) since their introduction in the 1960s. This study highlights how different types of SAPs influence key fluid management characteristics, including dry-to-touch performance, absorption capacity, and swelling behaviour.
Both Sensura Mio and Nova incorporate conventional SAPs, which deliver varying levels of fluid absorption and mechanical durability. In contrast, the TRE barrier formulation incorporates an insoluble super-absorbent polymer with pH buffering (iSAP+), specifically sodium polyacrylate, to create a next-generation HSB that offers versatile fluid management, enhanced durability and skin health support.
The TRE barrier represents an evolution in HSB design, distinguished by its iSAP+ based formulation. Continued advancements in material science, through both polymer innovation and formulation optimisation, will shape the future of ostomy technology, with the potential to improve patient comfort, skin protection and confidence-in-wear performance.
Acknowledgements
The author would like to thank Brian Hinsberger, McKenzie Jones and Michael Coen for data collection. Adam Airhart, Nada Ardeleanu, Joel Shutt and Dian Yuan are also acknowledged for reviewing the manuscript.
Conflict of interest
The author is senior lead scientist for breakthrough innovation at Hollister Inc. Dansac, manufacturer of TRE™, is a brand of Hollister Inc.
Funding
The author is a salaried employee of Hollister Inc.
从可溶到不可溶的时代:基于高吸水性聚合物的水胶体造口底盘演变研究
Adrian P Defante
DOI: 10.33235/wcet.45.3.28-36
摘要
目前市场上为造口患者提供的水胶体造口底盘(HSB)种类繁多,加大了不同产品及其特性的区分难度。根据HSB的材料组成进行分类,是一种可行的方法。本文基于材料组成,将HSB分为传统型、添加型、不可溶型三类。具体而言,本文通过测定液体管理能力与耐久性这两项性能指标,重点研究了高吸水性聚合物(SAP)在HSB中的应用。研究方法为对来自两家不同公司的三种HSB产品进行比较。结果显示,可溶与不可溶(iSAP)两种不同类型的SAP在性能上存在差异。本文进一步论证,通过添加pH平衡等附加功能特性,可对iSAP的制备工艺进行优化,开发iSAP+ HSB产品。
缩略语
CMC – 羧甲基纤维素
FAC – 液体吸收能力
GATS – 重量法吸收测试
HSB – 水胶体造口底盘
iSAP – 不可溶性高吸水性聚合物
iSAP+ – 含pH缓冲功能的不可溶性高吸水性聚合物HSB配方
KOH – 氢氧化钾
MARSI – 造口周围医用粘胶相关性皮肤损伤
PMASD – 造口周围潮湿相关性皮肤损伤
PSC – 造口周围皮肤并发症
SAP – 高吸水性聚合物
TEWL – 经表皮失水
引言
携带造口生活面临诸多挑战,其中,维持健康的造口周围皮肤是最关键的问题之一。造口周围皮肤并发症(PSC)会显著増加不适感,导致造口袋漏液,并降低生活质量。研究报道,PSC的发生率为36%–73%;1在一项涉及13个国家4227名造口人群的调查中,73%的患者在6个月内出现过PSC。2这些数据凸显了积极预防护理、及时的造口护理专业支持以及基于循证依据选择造口底盘的重要性。
大多数PSC的发生机制主要有两类:造口周围医用粘胶相关性皮肤损伤(MARSI)和造口周围潮湿相关性皮肤损伤(PMASD)。3,4
MARSI的发生机制为:造口产品中的粘胶与皮肤的黏附力超过皮肤细胞之间的内聚力。3这种情况可能导致皮肤剥脱、水疱及撕裂。造口底盘被反复揭除,可剥离皮肤的微观表层,破坏角质层,从而使皮肤更易遭受进一步损伤。
PMASD的形成,与潮湿环境相关Å\Å\汗液、经表皮失水(TEWL)、造口排泄物(粪便或尿液)等与皮肤接触,均可能引发该损伤。4表皮最外层的角质层维持约pH 4的酸性环境,形成一道酸性保护膜,用于维持皮肤完整性并抵御细菌和刺激物。然而,造口排泄物呈碱性(pH ~8),且含有消化酶,会破坏这一酸性保护膜,升高皮肤pH值并损伤表皮,最终导致PSC的发生。5
现代造口护理的核心在于水胶体造口底盘(HSB)的发展,其目的在于保护并维持皮肤完整性。HSB通过加入水胶体材料而具备液体管理能力与黏附性能,近年来更进一步引入了高吸水性聚合物(SAP)。SAP能够吸收并留存大量液体,这类材料为抵御潮湿引起的皮肤损伤提供了更强的防护作用。通过有效控制过多水分并维持最佳皮肤水合状态,整合SAP的水胶体造口底盘有望改善临床结局、降低PSC的发生率,并提升患者的整体体验。
这些吸收材料的性能在管理造口周围皮肤健康中发挥着至关重要的作用。SAP是皮肤水胶体配方的核心材料。6,7此类聚合物能够吸收相当于其自身重量30倍至1000倍的液体。虽然SAP普遍具有吸收液体的能力,但其吸收速率、吸收容量与溶解性会因类型不同而存在差异。利用这些材料特性的差异,推动了不同类型与不同代际HSB的发展。本文将根据SAP类型来源、容量与溶解性对HSB进行分类,并系统比较其在液体管理、耐久性及皮肤健康保护方面的表现。通过将聚合物科学与临床表现相结合,本研究旨在为基于循证依据的底盘选择提供参考,并推动造口技术的持续创新。
水胶体造口底盘材料
造口护理材料解决方案的起源
George Deppy、勃兰登堡-安斯巴赫的卡罗琳王后以及Margaret White,是最早有记载的造口患者。8在缺乏专业产品的年代,管理造口排泄物的选择极其有限。从18世纪至20世纪40年代,人们通常依赖简易自制的收集装置,如毛巾、金属容器、布袋或海绵,并用橡皮筋固定。9-11
最早用于造口护理中皮肤黏附的聚合物材料之一是卡拉亚树胶,它是一种天然聚合物,来源于刺梧桐树的汁液。卡拉亚树胶最初用于义齿黏合剂,并于1952年由造口治疗之父Rupert Turnbull博士引入造口护理。12-14Turnbull认识到该物质的吸收特性对于管理造口排泄物具有重要价值。然而,卡拉亚树胶的皮肤黏附力较弱,需要与其他聚合物材料(如羧甲基纤维素 [CMC]、甲基乙烯基醚-马来酸酐共聚物、聚异丁烯)结合使用,才能发挥有效作用。12
20世纪中叶,受大规模生产推动,合成聚合物的可及性日益提升,这为更先进、更可靠材料的研发创造了条件。这一创新成为HSB发展的重要转折点,使其能够专门针对造口患者的需求进行设计。20世纪70年代,出现了首批采用合成聚合物的HSB产品(如Stomahesive˛)。 15,16
图1展示了造口技术的发展历程。早期管理造口生活的解决方案主要依赖于自制方法,使用的材料并非专门为造口护理设计。如今,造口护理技术的设计已基本形成HSB+排泄物收集系统的结构模式。聚合物的应用从根本上改变了造口护理技术的发展路径,使科学家和工程师能够设计出具有特定功能的材料。

图1.造口护理技术的演化过程。
底盘配方中的聚合物
造口底盘性能的两个主要属性分别为皮肤黏附性(用于支撑排泄物收集系统)和体液管理能力(具体体现为吸收功能)。为实现上述功能,HSB通常由疏水性聚合物和亲水性聚合物的混合物组成。疏水性聚合物对水亲和力较弱,主要作用是提高皮肤黏附性和佩戴过程中的耐久性。在HSB配方中使用的疏水性聚合物示例包括聚异丁烯、苯乙烯嵌段共聚物衍生物和橡胶类聚合物。7,17亲水性聚合物则对水具有较强的亲和力,赋予HSB吸收造口排泄物与调节皮肤湿度的能力。大多数亲水性聚合物来源于天然材料,如树胶、木浆或果皮。在HSB中应用较为典型的亲水性聚合物包括卡拉亚树胶、CMC和果胶。 6,7,17
高吸水性聚合物
用于HSB的亲水性聚合物也可称为高吸水性聚合物(SAP)。SAP可按照其来源、液体吸收能力或溶解性进行分类。图2展示了两种SAPÅ\Å\ CMC和聚丙烯酸钠的材料特性,显示二者相对于自身重量具有极强的吸液能力。在造口护理中,SAP可来源于前文提到的天然材料,也可通过合成方式获得。常见的合成SAP示例包括聚丙烯酸钠、聚乙烯醇、聚乙烯吡咯烷酮和乙烯-马来酸酐。18

图2.a)液体吸收能力测定结果,显示两种液体的吸收行为差异和b)两种不同聚合物的液体吸收能力汇总。
用于测试的两种液体为水和0.9%生理盐水,代表了可能存在于造口排泄物中的不同离子强度或盐度范围。19CMC能吸收大量水分,且其吸收能力不受液体类型影响。聚丙烯酸钠吸收水的能力强于生理盐水,因为生理盐水中的离子会干扰其与水分子结合的能力,从而降低其吸收性能。因此,相较于聚丙烯酸钠,CMC的吸液量更低、适用液体范围更窄。此外,SAP还可根据其溶解性进行分类。综合来看,SAP可通过液体吸收能力与多功能性进行表征。
SAP可根据其溶解性进行分类。溶解性是指聚合物在液体中溶解的能力。可溶性SAP能够在液体中溶解,而不可溶性SAP(iSAP)不能溶解。这种差异源于iSAP的化学交联结构,该结构阻止其在液体中溶解。图3展示了可溶性与不可溶性SAP在液体中分散时的外观差异。聚丙烯酸钠在液体中呈现出浑浊状态[如雾状或乳状],表明这是一种iSAP。

图3.a)高吸水性聚合物的干湿状态,b)可溶性与不可溶性高吸水性聚合物溶解行为的可视化对比。
相比之下,CMC在液体中呈现清澈透明,表明该聚合物能够在液体中溶解。不同SAP在液体吸收量以及是否溶解(溶解性)上的差异,揭示了其作为高吸水性聚合物在性能上的显著区别。正是这些材料特性的差异(如吸收能力与溶解性),决定了不同类型水胶体造口底盘的配方设计。
材料和方法
材料:本研究测试了三种不同品牌的HSB: Nova˛、TRE˛(由Dansac A/S生产)和SenSura Mio˛(由Coloplast A/S生产)。为排除产品性能差异与生产批次波动的影响,每个品牌均选取3个生产批次进行测试。
研究选取了SAP类型不同的HSB,分别开展同一品牌内的横向对比及两个不同品牌间的纵向对比。通过该设计可实现三类对比分析:同一品牌下相同材料的性能比较、两个不同品牌下相同材料的性能比较,以及两个不同品牌下不同材料的性能比较。
方法
重量法吸收测试(GAT):取50 mg聚合物粉末,置于玻璃滤板上。液体从与天平相连的储液器经滤板流入。在聚合物吸液过程中,通过监测液体源重量随时间的变化评估吸收速率。
表面吸收速率与表面干燥度:为测量液体的吸收速率,将100 µL液滴滴加在直径20 mm底盘测试样片的黏附面(即与皮肤接触的一面)。底盘的背衬膜朝下,置于水平表面。液滴体积特意设计为大于样片表面积。
在液体滴加前,先行对带有离型膜的底盘称重。移除离型膜后,对离型膜单独称重。所有测试均在受控条件下进行(温度:21ÅãC–25ÅãC;相对湿度:30%–50%)。
每隔5分钟通过JAI Go-5100C相机(配备FUJINON HF12.5SA-1镜头)拍摄液滴图像,持续60分钟。在60分钟结束后,将Whatman 1滤纸覆盖于测试样片上,以吸收底盘表面残留的液体。随后在滤纸上方放置100克砝码,持续60秒,确保施加的压力均匀一致。
液滴高度通过ImageJ软件进行测量。液滴吸收速率计算方法为液滴体积随时间的百分比变化。
吸收进底盘的液体体积通过测试样品变化差值计算:m吸液总重–m干重–m离型膜。
底盘表面残留液体体积通过滤纸重量变化差值计算:m吸液总重–m干重。
液体吸收能力:液体吸收能力的测量遵循ISO 12505-1:2014标准。简要步骤如下:测试材料样片在置于储液器接触液体前后分别称重。将样品置于37ÅãC的环境箱内24小时,以模拟人体温度条件。放置时间结束后,沥干样片表面多余液体(沥干时间15分钟)后,记录其最终重量。接触液体前后重量的差值即代表材料的液体吸收能力。
膨胀比:膨胀比的测量方法是比较底盘在液体暴露24小时前后的厚度变化(吸收测试)。
侵蚀速率:侵蚀速率(mg/hr)通过测量样品在暴露于液滴冲击24小时前后的重量变化速率计算得出。液滴以3.1 mL/min的速率持续滴落。液滴大小通过22GA平口针头控制,流量由恒定的重力驱动静水压力调节。测试区域直径为13†mm,底盘厚度则因生产商而异。所有样品在测试前均于干燥器中预处理至少2小时。
pH滴定:使用Mettler Toledo T50滴定仪(配备DGi115-SC电极)测量酸值。直径25 mm的底盘样品置于烧杯中,加入50 mL 0.9%生理盐水。记录并输入样品的初始重量至仪器。在37ÅãC平衡24小时后,溶液用0.1 N氢氧化钾(KOH)滴定至中性pH 7。滴定仪自动记录KOH消耗体积、酸值(mg KOH/g样品)和初始pH。
数据分析:所有数据采用标准描述性统计方法进行汇总,用于分析连续变量(如平均值与标准差)。图表中的误差线均表示平均值Å}1标准差。时间变化模式通过线性趋势分析与亚线性趋势分析进行评价;其中,亚线性趋势分析以时间的平方根函数建模,用于评估随时间的变化情况。
结果和讨论
水胶体造口底盘(HSB)的核心功能在于实现皮肤黏附性与液体管理。本研究重点关注底盘SAP在体液管理中的作用效果,未对黏附性能进行评估,因其主要受疏水性聚合物的影响。本文比较了两种不同类型SAP配方设计的三种水胶体皮肤黏附剂在液体管理、耐久性和支持皮肤健康功能的潜力。
液体管理
液体管理是指HSB从接口处(如皮肤表面)移除液体的能力,以及其所能容纳的液体量。
图4展示了液滴在水胶体底盘表面60分钟内的吸收速率,模拟了皮肤表面液体的移除过程。结果显示,底盘对水与生理盐水的吸收模式存在显著差异。为评价吸收速率,本文采用了线性模型,其中斜率越陡的负斜线表示吸收速度越快。同时,为评估TRE底盘的水吸收速率,本文采用了Fick扩散模型。结果表明,TRE在所有测试的HSB与液体中表现出最高的吸收速率。

图4.a)三种不同水胶体造口底盘在0分钟与60分钟时的液滴吸收行为。
b)和c)液滴高度随时间变化的百分比变化及吸收速率汇总。所有水胶体造口底盘均呈线性吸收,TRE底盘除外。
这三种水胶体底盘中,水的吸收速度均快于生理盐水。这种差异可归因于生理盐水的离子强度,其会限制水分子与SAP的结合,从而减缓吸收速率。20在各类HSB中,Sensura Mio和Nova在吸收生理盐水和水时的速率相近,而TRE底盘则表现出显著更快的水吸收速率。这一差异提示TRE底盘在应对不同离子强度的液体(如常见的造口排泄物)时具有更强的适应性,进而提升了其从皮肤表面高效清除水分的能力。
图5展示了液体在水胶体底盘吸收60分钟后,仍残留在表面的液体量。这一数据与图4的吸收速率结果形成互补,因为液体吸收速度更快时,预期在皮肤-底盘界面残留的液体更少。图5b进一步确认了在所有测试系统中,总量保持守恒。

图5.a)触感干燥性测试结果,表征60分钟后残留于表面的液体量。b)未吸收与已吸收液体的质量平衡。
在以水为测试液体时,观察到TRE底盘的吸收量最多,表面残留液体量最少。Nova和Sensura Mio的水吸收能力依次降低。以生理盐水为测试液体时,Nova底盘表面残留液体量低于TRE和Sensura Mio。值得注意的是,在60分钟后,Sensura Mio底盘对两种液体的吸收量均为最低。TRE底盘的触感干燥性结果表明,该HSB能够更有效地从皮肤–底盘界面清除不同离子强度的液体。
图6展示了三种水胶体底盘在24小时后吸收的液体量。该测试重点评估了底盘在饱和液体环境中的液体吸收容量。Sensura Mio吸收的水与生理盐水量相近,提示其性能不受液体类型影响。相比之下,Nova与TRE底盘的吸收表现呈现液体依赖性。其中,Nova吸收生理盐水的量约比水高20%,而TRE吸收水的量则比生理盐水多约240%。总体来看,Nova和TRE底盘吸收的生理盐水量均略高于Sensura Mio,但TRE底盘在所有测试的HSB中表现出最高的水吸收能力。
图6c展示了各底盘的膨胀比。底盘膨胀是其吸收并留存液体的直观物理信号。Sensura Mio和Nova在两种液体中的膨胀表现相似,与其一致的吸收特性相符。然而,TRE底盘在水和生理盐水中的膨胀量均显著更高,反映了其更强的吸收能力。这种明显的膨胀现象可能为终端用户提供更直观的视觉或触觉信号,提示底盘正在有效吸收和管理皮肤表面的液体。
抗侵蚀性能是底盘耐久性的定量指标,能够反映其在湿润环境下的结构完整性。以下结果强调了SAP的引入如何在模拟使用条件下影响水胶体底盘的结构稳定性。

图6.液体属性测量数据:a)液体吸收能力,b)膨胀比和c)液体吸收能力与膨胀比之间的关系。
耐久性
图7展示了各水胶体底盘在暴露24小时后的抗侵蚀性能结果。该指标用于评估底盘在吸收液体的同时,因液滴冲击所产生的机械应力下的结构完整性。
虽然该测试模拟的条件比典型临床使用更为极端,但它可以作为底盘在患者活动中,尤其是在液体饱和状态下所承受物理应力的替代指标。侵蚀速率以毫克/小时(mg/h)表示。
测试底盘结果显示,在水和生理盐水中,Nova底盘的侵蚀速率最高,表明其随时间推移的抗降解能力最弱。相比之下,TRE与Sensura Mio在水中表现出较低的侵蚀速率,在生理盐水条件下,这两种材料的侵蚀速率相近。
水胶体底盘的抗侵蚀性能受其配方影响,尤其取决于可溶性与不可溶性成分的平衡。可溶性材料在接触液体时容易溶解,从而降低底盘的完整性。相比之下,不可溶性材料(如疏水性聚合物)则通过维持结构内聚性,提升湿润环境下的强度。因此,侵蚀速率低通常意味着配方中不可溶性材料成分占比较高。
TRE底盘的配方采用了不可溶性SAP(iSAP)。这种特殊聚合物既能吸收液体,又能维持结构完整性。正如前述测试方法所观察到的结果,iSAP使TRE底盘在高液体吸收能力与低侵蚀速率之间实现了平衡Å\Å\而这两项性能在传统水胶体底盘中往往难以兼得。
值得注意的是,TRE底盘在水中的侵蚀速率相较于在生理盐水中的表现以及相较于Sensura Mio均有所升高。其原因在于TRE底盘在水中的膨胀比极高,导致材料在测试过程中可能膨胀并溢出至相邻的测试孔(图7b)。尽管这一现象可能影响侵蚀测量的精确性,但在移除测试样品时,材料仍保持完整,这表明TRE底盘在饱和条件下依然能维持功能性耐久性。

图7.a)三种不同HSB的侵蚀速率,b)TRE水胶体底盘在吸液膨胀后扩散至其他测试孔位,相比之下,Nova底盘的膨胀程度较小
皮肤健康
以下结果表明,iSAP可有效应用于水胶体底盘的配方设计中,从而在支持皮肤健康的同时,兼顾液体管理性能与结构耐久性。
图8展示了酸值,该指标用于衡量水胶体底盘的缓冲能力。该参数反映了水胶体在暴露于碱性(腐蚀性)或富含酶的造口排泄物时,帮助维持皮肤酸性保护膜的能力。21在皮肤表面维持轻微的酸性pH对于保持皮肤完整性至关重要。
在图8a的可视化评估中,每种HSB均暴露于pH指示剂30分钟。指示剂溶液最初呈蓝色,反映出碱性环境。随着时间推移,液体颜色逐渐转变为黄色,表明环境趋于酸性。在所测试的屏障中,TRE水胶体显示出最快速且最显著的颜色变化,表明其缓冲反应较强。
为对该现象进行定量化评估,研究进一步采用滴定法计算各产品的酸值。与可视化结果一致,Sensura Mio和Nova的缓冲能力均极低。而TRE底盘表现出显著更强的反应,其酸值为其他底盘的4-5倍。
这些结果表明,在水胶体造口底盘中,可通过优化iSAP的设计,在不影响液体吸收或抗侵蚀性能的前提下,増强缓冲能力并促进皮肤健康。

图8.a)pH缓冲能力的可视化对比和b)pH缓冲能力的定量测定结果。
高吸水性聚合物技术对水胶体造口底盘发展的影响
图9展示了水胶体造口底盘技术的发展历程,追溯了其液体管理性能从早期基于卡拉亚树胶材料到现代整合SAP的演进过程。传统型HSB的主要功能是吸收水分并保护造口周围皮肤免受排泄物刺激,这一基本功能构成了此类产品后续开发的基础框架。当前的代表性产品,如Sensura Mio、Nova与TRE底盘,皆满足这一基本液体处理要求,体现了传统功能的延续。

图9.按高吸水性聚合物类型和水胶体底盘配方细分的SAP技术应用的演化过程。
在这一框架基础上,新一代HSB通过将SAP与支持皮肤健康的成分相结合实现了性能提升,而SAP的具体类型差异进一步推动了产品功能分化。例如,TRE屏障中整合的iSAP在体液管理方面具备更广泛的适用性,可实现更快速的触感干燥性能,并能有效吸收不同离子强度的液体Å\Å\这一能力在SenSura Mio或Nova底盘中并不显著。值得注意的是,尽管三款产品在液体吸收总量上相当,但TRE底盘在功能表现上仍体现出优势。
iSAP还通过聚合物交联过程提升了机械耐久性。然而,耐久性也可能受到整体配方的影响。例如,尽管Sensura Mio和Nova均采用常规SAP,但Sensura Mio的抗侵蚀性能优于Nova。
最后,TRE底盘配方实现了基于iSAP的液体管理功能与pH缓冲技术等附加功能的结合,以支持皮肤健康。这类由不可溶性高吸水性聚合物结合pH缓冲能力构成的复合型HSB配方(iSAP+),使TRE底盘在本研究中区别于其他产品,标志着现代水胶体造口底盘在多功能设计方面迈出了重要一步。
结论
自20世纪60年代引入以来,高吸水性聚合物(SAP)在水胶体造口底盘(HSB)的发展中发挥了基础性作用。本研究强调了不同类型SAP对关键液体管理特性的影响,包括触感干燥性、吸收容量、膨胀行为。
Sensura Mio与Nova融合了常规SAP,在液体吸收能力和机械耐久性方面表现出不同水平。相比之下,TRE底盘配方中整合了一种具有pH缓冲功能的不可溶性高吸水性聚合物(iSAP+),具体为聚丙烯酸钠,从而形成新一代HSB,可具备更强的液体管理适应性,提升耐久性,并支持皮肤健康。
TRE底盘是HSB设计领域的一次技术演进,其显著特征在于基于iSAP+的配方设计。随着材料科学的不断进步,尤其是聚合物创新与配方优化,未来的造口护理技术将持续发展,进一步提升患者舒适度、皮肤保护效果及佩戴可靠性。
致谢
作者特别感谢Brian Hinsberger、McKenzie Jones和Michael Coen参与数据收集工作。同时,也感谢Adam Airhart、Nada Ardeleanu、Joel Shutt和 Dian Yuan对稿件的审阅与反馈。
利益冲突
作者是Hollister Inc.突破性创新部门的高级首席科学家。TRE˛的制造商Dansac为Hollister Inc.旗下品牌。
资助
作者是Hollister Inc.的受薪员工。
Author(s)
Adrian P Defante PhD
Senior Lead Scientist Breakthrough Innovation
Hollister Inc, USA
Email adrian.defante@hollister.com
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