The goal of this clinical trial is to determine whether adding a β-glucan moisturizing cream to routine skin care can enhance skin healing, accelerate visible recovery, reduce discomfort, and improve both patient and clinician experiences. The study will also learn about the safety and tolerability of the β-glucan cream when used along with standard skin care.

The main questions it aims to answer are:

Are there visible changes in the severity of IAD when β-glucan cream is added to standard care, and if so, to what extent does it reduce severity compared with standard care alone?

Does the β-glucan cream help IAD heal faster?

Does the cream reduce symptoms such as pain, itching, tingling, or burning?

What medical problems or side effects, if any, do participants experience while using the β-glucan cream?

Researchers will compare standard care plus β-glucan cream to standard care alone to see if the β-glucan cream provides additional benefit for treating IAD.

Participants will:

Receive either β-glucan cream plus standard care or standard care alone

Have the study cream applied once daily for up to 2 weeks

Have their skin checked weekly by the study team using a standardized assessment tool

Answer questions about symptoms such as pain, itching, tingling, and burning

Allow photographs of the affected skin area to be taken for secure clinical review

Be monitored for any side effects or skin reactions during the study

Purpose:

The purpose of this study is to evaluate the use of a commercially available cosmetic moisturizer, a topical barley-derived β-glucan cream (Soothing Beta Cream, By Dr. Mom; Cosmetic Notification Number 03481502), as a hydrating and soothing agent when used in addition to standard skin care for adults with incontinence-associated dermatitis (IAD). The study will assess the tolerability, usability, and effects of this cosmetic moisturizer on the visible appearance of moisture-associated skin irritation in hospitalized adults with IAD when used alongside routine cleansing and barrier products.

Hypothesis:

We hypothesize that adding a 0.5% β-glucan moisturizing cream to standard skin care will improve the visible severity of IAD compared with standard care alone. This improvement will be reflected by lower Ghent Global IAD Monitoring Tool (GLOBIAD-M) severity scores, including reductions in redness, skin loss, edema or maceration, and other observable skin changes associated with IAD, as well as shorter time to healing and improvements in patient-reported symptoms such as pain, itching, tingling, and burning captured within the GLOBIAD-M assessment.

Justification:

IAD is a common and painful inflammatory skin condition resulting from prolonged exposure to urine and/or feces, affecting up to 19% of hospitalized adults in Canada. Effective management of IAD relies on three key approaches: gently cleansing the skin to remove urine and/or feces, applying a moisturizer to support skin hydration and barrier integrity, and using a protective barrier product to help shield the skin from further exposure to moisture and irritants. While a variety of cleansers and barrier products are used in clinical practice, the choice of accompanying moisturizing products often varies significantly between institutions and clinicians, with limited comparative evidence guiding product selection. The lack of specific, evidence-based product selection contributes to variability in outcomes, may delay effective skin barrier repair, and can lead to inefficient or suboptimal care practices.

β-Glucan, a naturally derived polysaccharide, has reported humectant and hydrating properties, which help support skin hydration and improve the appearance of dry or irritated skin. By interacting with the immune receptor dectin-1, β-glucan also modulates cytokine production and macrophage activity, mechanisms central to resolving inflammation and promoting tissue regeneration. Additionally, β-glucan exhibits antimicrobial activity, including against Candida species, which may further support healing in skin affected by IAD.

Given the variability in care practices and the promising properties of β-glucan, we propose to evaluate the use of a commercially available β-glucan cream developed at the University of Alberta, Soothing Beta Cream (By Dr. Mom), as an adjunct moisturizer within a standard skin care regimen for adults with IAD. Ultimately, this study aims to generate robust evidence by assessing the hydrating and soothing role of this β-glucan cream in supporting the management of IAD.

Objectives:

1. Evaluate visible changes in the IAD severity using the validated GLOBIAD-M assessment tool when a β-glucan moisturizing cream is used alongside standard care compared with standard care alone.
2. Compare time to healing between the intervention and control groups.
3. Assess patient- and clinician-reported outcomes, including pain, itching, tingling, burning, overall symptom improvement, and qualitative feedback on cream acceptability, feel, and ease of application.
4. Evaluate the safety and tolerability of the β-glucan cream in hospitalized adults with IAD, including any adverse effects reported by patients or observed by clinicians.

Research Method/Procedures:

Study Design

This study will recruit 60 adults with clinically diagnosed IAD admitted to the inpatient units at the University of Alberta Hospital. Diagnosis will be confirmed by a geriatrician or dermatologist, with skin biopsy only if clinically indicated. Participants will be randomized 1:1 via REDCap to receive either β-glucan cream plus standard care (n = 30) or standard care alone (n = 30).

The moisturizer used in this study is By Dr. Mom's Beta Glucan Cream (Cosmetic Notification Number 03481502), a commercially available cosmetic product intended to hydrate and soothe dry or irritated skin.

Standard of care for IAD management is cleansing followed by application of barrier protection. The cleanser is either with Skintegrity™ Wound Cleanser or normal saline for sensitive skin, and the barrier product is Baza® Protect II Zinc Oxide Skin Protectant Cream (a zinc oxide and dimethicone product) for mild or intact IAD or Coloplast Critic-Aid Clear (a petrolatum and dimethicone product) for moderate to severe IAD.

The β-glucan cream will be applied as needed as a moisturizing agent, in addition to standard cleansing and barrier protection, and participants will be monitored for up to two weeks.

Due to the absence of a placebo comparator, this study incorporates partial patient blinding. Participants will be informed that they will receive standard care with or without an adjunctive moisturizing therapy but will not be explicitly informed of their group allocation. However, outcome assessment will be fully blinded, with a geriatrician or dermatologist evaluating IAD severity without knowledge of treatment allocation, Standardized assessment methods (e.g., validated IAD severity scales and/or clinical photography) will be used to minimize bias.

Inclusion and Exclusion Criteria

Eligible participants are adults (≥18 years) with IAD secondary to urinary and/or fecal incontinence and an expected hospital stay of ≥7 days. Written informed consent will be obtained directly or via substitute decision-maker. Exclusion criteria include absence of IAD or incontinence, pediatric patients, and participants with known hypersensitivities to components of cream (e.g. beta-glucan).

Quantitative Data Collection and Assessment Procedures

Participants will be identified by medical students, residents, physicians, or wound care nurses (RNs), licensed practical nurses (LPNs), care aides, occupational therapists (OTs), or unit managers. With informed consent, clinical photographs will be captured using secure hospital devices (e.g., Haiku mobile application) and uploaded directly to the Media section of Connect Care for independent review by dermatology and/or geriatrics. Images will be stored exclusively within Connect Care, and no patient data will be stored or transferred outside of this system. IAD severity will be assessed using the validated GLOBIAD-M tool at baseline and weekly until resolution or for a maximum of two weeks. Assessments will be performed independently by a dermatologist and a geriatrician, both blinded to the intervention, and inter-rater reliability between the two clinicians will be calculated. The GLOBIAD-M assessment captures multiple aspects of IAD-associated skin damage, including the percentage of affected skin with redness or skin loss, the presence of edema or maceration, and signs of secondary skin changes such as infection (scored 0-5). GLOBIAD-M also incorporates patient-reported outcomes, including itching, tingling, burning, and pain, measured using a 0-10 numeric rating scale.

At the end of the intervention period, two versions of a brief survey will be administered-one for patients and one for nursing staff. Both surveys will share the same core Likert-scale items, but each may include additional group-specific questions tailored to the participant type: patients will rate cream acceptability, texture, ease of application, and any discomfort or adverse sensations, while nursing staff will rate ease of application, observed skin reactions, and usability during routine care.

Qualitative Feedback

At the end of the intervention period, brief open-ended survey questions will be administered to both patients and nursing staff. Patients will provide feedback on cream texture, comfort, and any adverse effects. Nursing staff will provide feedback on ease of application, observed reactions, and suggestions for improvement. All qualitative responses will be coded line-by-line and analyzed using thematic analysis, grouping codes into patterns and identifying broader themes. This process will capture patient and clinician perspectives on cream acceptability, usability, tolerability, and overall satisfaction. The findings from thematic analysis will complement quantitative endpoints to provide a comprehensive evaluation of the β-glucan cream's clinical effectiveness and user experience.

Feasibility

Based on patient volumes, 3-5 eligible participants per week are expected, allowing recruitment within 4-6 months.

Plan for Data Analysis:

Quantitative Analysis

Baseline characteristics (e.g., age, sex/gender, main reason for admission and route, length of hospital stay, and incontinence type/episodes/duration) will be obtained through chart review in Connect Care and summarized descriptively using means and standard deviations for continuous variables and counts and percentages for categorical variables.

Primary and secondary outcomes will be analyzed as follows:

1. Continuous outcomes (e.g., percentage of affected skin with redness or skin loss) will be analyzed using linear mixed-effects models, accounting for repeated measures within participants over time.
2. Binary outcomes (e.g., presence of edema, maceration) will be analyzed using generalized linear mixed-effects models with appropriate link functions (e.g., logit).
3. Ordinal outcomes (e.g., GLOBIAD-M severity categories, pain type) will be analyzed using ordinal mixed-effects models, allowing assessment of changes over time between treatment groups.
4. Time-to-event outcomes (e.g., time to full healing) will be analyzed using Kaplan-Meier survival analysis to estimate median healing times and Cox proportional hazards models to compare groups while adjusting for relevant covariates.

Assuming a moderate effect size (Cohen's d = 0.7), 26 participants per group provide 80% power at α = 0.05. To allow for attrition, 30 participants per group will be recruited (total n = 60). Adjunctive β-glucan therapy is expected to reduce IAD severity, shorten healing time, and improve patient-reported outcomes compared with standard care alone.

Qualitative Analysis: Thematic Analysis

Open-ended survey responses from patients and nursing staff will be collected electronically via REDCap on tablets and exported securely for analysis. Responses will be managed using qualitative analysis software (e.g., NVivo) and analyzed using a structured thematic analysis process as follows:

1. Familiarization: Survey responses will be read repeatedly to identify preliminary insights and patterns.

2. Coding: Meaningful units of text (e.g., "smooth texture," "slight burning") will be assigned short descriptive codes that capture key concepts in patient and clinician experiences.

3. Generating Themes: Codes will be grouped into broader themes based on recurring patterns. The following table summarizes anticipated themes, associated codes, and representative example quotes:

   The participant reported, "The cream felt smooth and soothing, not sticky at all," which was coded as Smooth, soothing, non-sticky, not greasy and grouped under the theme Positive Sensory Experience.

   The participant reported, "Application was simple and quick," which was coded as Easy to apply, spreads easily, simple and grouped under the theme Ease of Application.

   The participant reported, "I felt a slight burning the first day," which was coded as Slight burning, tingling, itchiness and grouped under the theme Minor Adverse Effects.

   The participant reported, "Overall, it seems well-tolerated, and patients seemed comfortable," which was coded as Comfortable, well-tolerated, soothing and grouped under the theme Overall Satisfaction / Tolerability.

4. Reviewing and Refining Themes: Themes will be iteratively reviewed and refined to ensure they accurately represent the experiences reported by patients and nursing staff.

5. Integration with Quantitative Findings: Thematic findings will be summarized descriptively and integrated with quantitative outcomes (e.g., GLOBIAD-M scores, pain, itching, tingling, burning) to provide a comprehensive understanding of clinical effectiveness, safety, usability, and satisfaction.

Eligible participants are adults (≥18 years) with IAD secondary to urinary and/or fecal incontinence and an expected hospital stay of ≥7 days. Written informed consent will be obtained directly or via substitute decision-maker. Exclusion criteria include absence of IAD or incontinence, pediatric patients, and participants with known hypersensitivities to components of cream (e.g. beta-glucan).

Because this is a parallel-group study with blinded outcome assessment rather than a double-blind design, routine unblinding is not applicable. Participants and treating staff are aware of treatment allocation, while outcome assessors remain blinded.

Topical β-glucan is associated primarily with mild, localized skin reactions such as redness, irritation, or itching, and true systemic allergic reactions (e.g., anaphylaxis) are extremely rare. In the unlikely event of a suspected adverse skin reaction potentially related to the β-glucan cream, the study intervention will be discontinued and the participant will receive standard clinical care as indicated. Knowledge of treatment allocation will not need to be disclosed to outcome assessors in order to manage adverse events.

Outcome assessors will remain blinded to treatment allocation at all times. Any adverse events and any actions taken in response will be documented and reviewed as part of ongoing safety monitoring.