Clinician Perspectives on the Safety, Usability, and Performance of a Film-Forming Barrier in Wound Care

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.

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Publication Details

Journal
Journal of Wound Management and Research
Published
2026-06-30
DOI
https://doi.org/10.22467/jwmr.2026.03706
Primary Topic
Wound Healing and Treatments
Type
article
Field-Weighted Citation Impact
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article

Clinician Perspectives on the Safety, Usability, and Performance of a Film-Forming Barrier in Wound Care

Elaine Minagh, Niuosha Sanaeifar, Hanna Koch
Journal of Wound Management and Research
Wound Healing and Treatments
article

Clinician Perspectives on the Safety, Usability, and Performance of a Film-Forming Barrier in Wound Care

Elaine Minagh, Niuosha Sanaeifar, Hanna Koch
article en

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.

Journal of Wound Management and ResearchVol. 22(2)
Avery Dennison (United States) (US), Hartmann Group (Germany) (DE)
Openalex Percentile: Top 10%
Wound Healing and Treatments
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