Clinician Perspectives on the Safety, Usability, and Performance of a Film-Forming Barrier in Wound Care
Article information
Abstract
Background
Moisture-associated skin damage is a common complication in wound care, often resulting from skin exposure to exudate, urine, or stoma effluent. While film-forming barrier products are intended to protect compromised skin, evidence in routine practice remains limited. This study evaluated clinician-reported safety, performance, and usability of a film-forming barrier product in a post-market clinical follow-up (PMCF) survey.
Methods
This structured, non-interventional PMCF user survey was conducted among healthcare professionals who had used the product in routine clinical practice. The questionnaire assessed clinician-reported performance, safety/tolerability, and usability using a 5-point Likert-scale, yes/no, and open-ended questions. Responses from 192 completed questionnaires were analyzed descriptively and compared with a predefined 75% positive-response acceptance criterion.
Results
All evaluated characteristics exceeded the 75% acceptance threshold. Clinicians reported positive ratings for ease of application and the product’s ability to form a waterproof yet breathable barrier. Safety/tolerability findings indicated that 82.8% reported no skin irritation, 78.6% no adverse events, and 75.5% no stinging sensation during use. Usability feedback was positive, with 84.4% indicating that the product performed its intended protective function, 85.9% willing to use it again, and 92.7% finding the instructions for use sufficiently clear.
Conclusion
This PMCF survey indicates favorable clinician-reported safety/tolerability, usability, and barrier-related performance in routine practice. As findings were based on subjective clinician-reported data from a non-comparative survey, they should be interpreted as real-world user experience rather than objective evidence of clinical effectiveness. Further prospective studies with objective clinical assessments and patient-level outcomes are warranted.
Introduction
Intact skin provides an essential protective barrier against irritants, moisture loss, and microbial contamination [1]. In wound care, this barrier may be compromised by aging, fragile skin, repeated dressing changes, adhesive trauma, and prolonged exposure to wound exudate or other bodily fluids [1-3]. Such exposure can contribute to maceration and moisture-associated skin damage (MASD), particularly in the periwound area. MASD includes several clinical presentations, including periwound MASD, peristomal skin damage, intertriginous dermatitis, and incontinence-associated dermatitis [1,4]. Of these subtypes, periwound MASD is particularly relevant in chronic wound management. Persistent wound exudate can saturate and weaken the surrounding skin, leading to maceration and potential deterioration of the wound edge [5,6]. Moreover, chronic wound fluid contains proteolytic enzymes and pro-inflammatory mediators that can degrade otherwise healthy skin, rendering the exudate highly detrimental to adjacent intact tissue [7]. Beyond these moisture-driven injuries, mechanical forces can also compromise at-risk skin; for instance, repeated adhesive dressing removal may strip away the superficial epidermis, causing a painful medical adhesive-related skin injury that increases infection risk and can impede healing [2].
A key preventive strategy to address these challenges is the use of topical skin barrier products to protect vulnerable skin sites [1]. Traditional moisture barriers, such as zinc oxide or petrolatum-based preparations, can protect the skin from irritants by repelling fluids; however, they may be occlusive, unwieldy to use, and disruptive to wound dressing adhesion. Alcohol-free film-forming barrier products have emerged as an alternative and are intended to create a thin protective layer between vulnerable skin and external irritants, while remaining practical for use in routine care [7-10]. Previous studies have reported favorable usability, tolerability, and acceptability of no-sting barrier films in wound and skin protection settings; however, the available evidence remains limited by heterogeneous study designs, variable outcome measures, and relatively few real-world evaluations [8-11]. Consequently, there remains a need for additional post-market data describing how film-forming barrier products are perceived by healthcare professionals when used under routine wound care conditions.
In this context, post-market clinical follow-up (PMCF) survey data can provide useful insight into real-world product use under routine clinical conditions. Because application, handling, barrier formation, and local tolerability are key practical aspects encountered during routine care, feedback from healthcare professionals is relevant for evaluating product use in clinical practice. Therefore, the present study evaluated clinician-reported safety/tolerability, usability, and perceived performance of a film-forming skin barrier under routine clinical conditions.
Methods
Study design
This study was a proactive PMCF user survey conducted within the manufacturer’s post-market surveillance framework. The survey was conducted between April and July 2023. The product’s distributor sent the questionnaire to healthcare professionals at facilities that had previously purchased the barrier film. All respondents, by design, were actual users of the product in clinical practice. The PMCF evaluation incorporated all configurations of the barrier film product range, as they shared the same formulation and intended use and differed only in the mode of application.
Respondent characteristics
A total of 192 completed questionnaires were included in the analysis. Respondents included nurses, nurse practitioners, physicians, physician assistants, and other healthcare professionals. All respondents confirmed that they were licensed healthcare professionals and qualified to work with the product. Patient age was collected solely as categorical data to provide context for product utilization and was excluded from patient-level outcome analysis.
Survey instrument and data collection
Data were collected using a structured questionnaire developed in accordance with a prespecified PMCF plan. Formal psychometric validation of the questionnaire was not documented in the available PMCF materials. The questionnaire included 5-point Likert-scale items, yes/no questions, and open-ended questions.
The evaluated domains included clinician-reported product performance, safety/tolerability, and usability/user acceptance. Product performance referred to the practical performance characteristics assessed in the survey, including ease of application, formation of a waterproof barrier, formation of a breathable layer, and absence of performance issues during use. Safety/tolerability was evaluated using separate questionnaire items on skin irritation, safety issues/adverse events during use, and stinging sensations; for reported adverse events, clinicians were additionally asked to assess the likelihood of a relationship to product use, categorized as unrelated, possibly/causally related, probably related, or unknown. Usability/user acceptance included clinician ratings of intended-use fulfilment, willingness to use the product again, and clarity of the instructions for use. In this context, willingness to use the product again was interpreted as an indicator of user acceptance. Qualitative comment fields allowed respondents to provide additional observations from routine practice.
Data analysis
Survey responses were tabulated and analyzed descriptively. For each questionnaire item, response frequencies and percentages were summarized and compared with the pre-determined acceptance criteria defined in the PMCF survey plan. Individual response categories were retained for full descriptive reporting in Supplementary Table 1; however, the top two response options (e.g., Very good/Good and Strongly agree/Agree) were consolidated into a single “positive” category, in accordance with the predefined analysis plan. An item was considered to meet the acceptance criterion if at least 75% of responses were positive. This predefined threshold was specified in the PMCF survey plan and was used as a pragmatic benchmark to indicate broad clinician acceptance of the product’s safety/tolerability, performance, and usability under routine conditions of use, thereby supporting the post-market benefit–risk assessment.
The 192 completed questionnaires available for analysis successfully met the minimum sample size requirements predefined in the PMCF survey plan. No formal a priori sample-size calculation based on statistical power, anticipated response rate, population size, or a prespecified margin of error was documented in the available PMCF materials. Because the predefined PMCF analysis summarized the main outcomes as positive-response proportions, including combined Likert-scale responses, the achieved sample size can be interpreted in relation to estimation of a single proportion using the formula n=Z2×p(1−p)/e2, where Z=1.96 corresponds to a 95% confidence level, p represents the expected positive-response proportion, and e denotes the margin of error. With a sample size of 192, the approximate margin of error is ±6.1% around the predefined 75% positive-response acceptance threshold and ±7.1% under the conservative assumption of p=0.50. Therefore, the achieved sample size was considered adequate for the intended descriptive PMCF evaluation of clinician-reported positive-response rates, notwithstanding that the study was not designed to support narrow-margin population estimates or formal hypothesis testing. The number of healthcare professionals invited to participate was not documented; therefore, an anticipated or actual response rate could not be calculated.
No deviations from the PMCF plan were reported during study conduct. As the survey relied on clinician-reported responses, no independently verified objective clinical outcomes, standardized wound or skin assessments, patient-reported outcomes, or comparator-group data were available for analysis.
Ethical considerations
This activity was conducted within the manufacturer’s post market surveillance and PMCF framework and took the form of a non interventional user survey. Participation was voluntary, and returning a completed questionnaire was considered implied consent. The present analysis is based exclusively on aggregated, anonymized clinician responses and contains no identifiable patient information. As this post market feedback activity involved retrospective clinician reporting under routine conditions of use and did not include any patient level data or interventions, formal ethics committee approval was not required under the applicable operational framework.
Study product
The evaluated product (HARTMANN MedProtect Film [Spray and Swab], Paul Hartmann AG) is an alcohol-free, film-forming skin protectant intended for use on intact or damaged skin. Available in spray and swab formats, it is based on a liquid acrylate-copolymer formulation that dries on the skin to form a transparent, waterproof layer that protects the skin from bodily fluids while still permitting moisture vapor transmission. The product is indicated to protect skin from the detrimental effects of incontinence (urine/fecal), wound exudate, and stoma effluent, thereby providing comprehensive periwound and peristomal skin protection.
Results
Clinician-reported performance outcomes
Across the predefined performance domains, positive-response rates ranged from 78.1% to 90.1%. Ease of application was rated positively by 90.1% of respondents. In addition, 82.8% reported that the product formed a waterproof barrier, and 81.7% reported that it formed a breathable layer on the skin. A further 78.1% of respondents indicated that no performance issues were encountered during use. A summary of these performance outcomes is shown in Table 1.
Clinician-reported performance outcomes from the PMCF survey (n=192)
Safety and tolerability
The majority of clinicians reported no safety or tolerability concerns. For the direct skin-irritation question, 82.8% reported no skin irritation, whereas 15.6% reported skin irritation. In a separate question, 78.6% reported no adverse events during use, while 17.2% (33/192) reported an adverse event. In the PMCF report, these adverse-event reports were described as skin irritation/trauma. Of the 33 reported events, 12 were considered unrelated to the product, 18 were assessed as possibly or causally related, two as probably related, and one was unspecified. In addition, 75.5% reported no stinging sensation. These findings are summarized in Table 2.
Clinician-reported safety and tolerability outcomes from the PMCF survey (n=192)
Usability and user acceptance
Clinician-reported usability outcomes indicated that the product fulfilled its intended use according to 84.4% of respondents, and 85.9% stated that they would use the product again in the future. The highest positive-response rate was observed for the clarity of the instructions for use, which was rated positively by 92.7% of respondents (Table 3).
Clinician-reported usability and user acceptance outcomes from the PMCF survey (n=192)
Discussion
The present PMCF survey found that all evaluated product characteristics surpassed the 75% positive-response acceptance criterion. Overall, the findings indicated positive clinician-reported ratings for perceived barrier-related performance, safety/tolerability, and usability under routine conditions of use.
Ease of application is a critical factor in clinical practice, as products that are simple and quick to use can reduce nursing time, improve workflow efficiency, and support consistent application across care settings. Previous studies have highlighted that user-friendly barrier films are associated with improved compliance and reduced risk of application errors, which can be particularly important in busy wound care environments or when care is delegated to less experienced staff [7,8].
The high clinician-reported ratings for waterproof barrier formation and breathability are relevant because these product characteristics are considered important for protecting at-risk skin and maintaining an appropriate skin microenvironment in wound care. Effective waterproofing helps protect peri-wound and other vulnerable skin areas from exposure to exudate, urine, or other bodily fluids, thereby helping to reduce the risk of maceration, discomfort, and secondary complications associated with MASD [7,12]. At the same time, breathability remains important because a barrier film that allows moisture vapor transmission may help support skin integrity by limiting excessive moisture accumulation. Semi-occlusive dressings and breathable films have been reported to be associated with a reduced risk of skin breakdown compared with fully occlusive products [7].
The safety/tolerability findings should be interpreted with caution. Although most respondents reported no safety or tolerability concerns, a minority reported skin irritation, adverse events, or stinging sensation during use. These findings are broadly consistent with the literature recognizing that adhesive-related skin injury and irritant reactions may occur during product use, particularly in vulnerable skin [2]. However, because the safety findings were based on clinician-reported survey responses without independent clinical verification or detailed patient-level information, causal attribution to the product cannot be confirmed. Continued post-market surveillance therefore remains important to monitor safety/tolerability outcomes during routine use.
The clinician-reported usability and acceptance findings (e.g., 85.9% would use again, nearly 93% found instructions clear) suggest that clinicians may consider the product feasible to incorporate into routine practice. Clear instructions may support correct application and reduce the risk of misuse, while willingness to use the product again reflects user acceptance under routine conditions of use [13]. However, these subjective usability and acceptance findings may be influenced by user preference, familiarity with the product, workflow conditions, and local practice patterns, and may not fully reflect objective clinical performance or patient-level outcomes.
The study has several limitations. First, the findings are based on voluntary self-reported clinician assessments and may therefore be subject to response, reporting, recall, and selection bias. In particular, respondents were healthcare professionals from facilities that had previously purchased or used the product. This may have enriched the sample with clinicians possessing prior familiarity or favorable experience with the barrier film, thereby limiting generalizability to all potential users.
Second, the survey did not include independently verified objective clinical assessments, such as standardized skin or wound evaluations, wound measurements, photographic assessment, patient-reported outcomes, or comparator-group data. Therefore, conclusions regarding comparative clinical superiority, relative effectiveness, direct patient benefit, or causal effects on wound healing cannot be drawn.
Third, additional contextual information on clinical setting and wound type was limited. Although facility information was available in the source dataset, clinical setting and wound type were not collected as standardized variables, and no patient-level wound characteristics were available for analysis. Given these limitations, stratified analyses based on care setting, wound type, or wound severity were precluded.
Accordingly, the findings should be interpreted as real-world clinician-reported user-experience data supporting product acceptance and perceived performance under routine conditions of use. Future prospective studies should collect standardized information on clinical setting, wound type, wound severity, objective clinical assessments, and patient-level outcomes to better contextualize and confirm these findings.
The PMCF survey findings suggest generally positive clinician-reported evaluations of the barrier film across key areas, including perceived barrier-related performance, safety/tolerability, and usability with all evaluated characteristics exceeding the predefined 75% positive-response threshold. Most respondents reported no safety or tolerability concerns, although a minority reported skin irritation, adverse events, or stinging sensation during use. Given the non-comparative design and reliance on clinician-reported assessments, these findings should be interpreted as real-world user-experience data rather than definitive evidence of clinical effectiveness. Continued post-market surveillance and further prospective studies incorporating objective clinical assessments, patient-level outcomes, and, where feasible, comparator groups are warranted to confirm these findings and further define the product’s role in wound management.
Notes
Niuosha Sanaeifar and Hanna Koch are full-time employees of Paul Hartmann AG. Elaine Minagh is a full-time employee of Avery Dennison Medical Ltd. Avery Dennison Medical Ltd. provided access to the anonymized PMCF survey dataset. Survey completion was performed by healthcare professionals via the distribution partner, and completed surveys were tabulated before the dataset was made available for manuscript analysis. Avery Dennison Medical Ltd. was not involved in manuscript drafting.
Acknowledgments
This manuscript was prepared with the assistance of artificial intelligence (AI) tools for drafting, language editing, and formatting. AI tools were not used for data analysis or scientific interpretation. All analyses, interpretations, and final manuscript decisions were made by the authors.
Supplementary material
Full item-level response distribution for PMCF survey items. Supplemental data can be found at: https://doi.org/10.22467/jwmr.2026.03706