Comparison of an Enhanced Barrier Cream to Standard of Care for the Treatment of Moisture Associated Skin Damage From Fecal Incontinence in an Ambulatory Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- GLOB-IAD Clinical Assessment
研究概览
简要总结
Liquid stool and diarrhea are associated with an increased risk for moisture-associated skin damage (MASD), and clinical evidence suggests that exposure to liquid stool is associated with severe MASD and extensive erosion of affected skin. There are no known products on the market that treat fecal incontinence or MASD caused by fecal enzyme activity.
Scotiaderm has invented a novel barrier cream (Dermategrity Everyday Barrier Cream) with an enhanced formula containing zinc oxide and a natural plant extract that inhibits fecal enzymes to protect the skin while preventing further breakdown. Dermategrity Everyday Barrier Cream has shown superior outcomes in comparison to zinc oxide alone in simulated laboratory testing, and promising results have been obtained in clinical case studies. To date, however, there has been no formal clinical testing of this new barrier product in comparison to standard zinc oxide creams.
The purpose of this study is to perform a randomized, controlled clinical study comparing Dermategrity Everyday Barrier Cream to zinc oxide barrier cream to determine if there is a difference in healing, clinical outcomes, and the speed of resolution of MASD symptoms between groups, in an ambulatory patient population.
详细描述
Moisture associated skin damage (MASD) is a grouping of painful, irritating rashes which occur when a patient has repeated or prolonged exposure to moisture from perspiration, urine and/or feces. Commonly encountered rashes in this group include incontinence-associated dermatitis (IAD) and intertrigo (ITD). These conditions can affect as many as one in five hospitalized patients and up to 50% of intensive care unit patients, putting them at risk of skin breakdown, serious infection, and the development of pressure ulcers. MASD is a common but overlooked and under-reported skin care problem, and there are many gaps in the knowledge of how best to treat these rashes.
Liquid stool and diarrhea are associated with an increased risk for MASD when fecal materials remain in contact with the skin for a prolonged period. Diarrhea is associated with an increased likelihood of IAD in children, and clinical evidence suggests that exposure to liquid stool is associated with severe MASD and extensive erosion of affected skin. Liquid stool is also rich with coliform bacteria, and the gastrointestinal tract acts as a reservoir for various fungal species including Candida, which commonly complicates IAD. Liquid stool contains higher concentrations of proteolytic enzymes with the potential to impair the moisturizing effects of proteins such as filaggrin, and the softening effects of the intrinsic lipids in the skin, both of which are vital in maintaining the barrier functions in skin. These effects are exacerbated by a more alkaline pH and the higher concentrations of active fecal enzymes associated with diarrhea. Research on incontinent patients in the intensive care unit shows that the mean time to development of MASD is 4 days. The presence of liquid stool is an independent risk factor for the development of IAD, with patients developing IAD at a rate of 1.5x that of patients who are continent.
The current standard of care for the treatment and prevention of MASD involves a structured skin care regiment that involves cleansing of the skin to remove excessive moisture and irritants with a pH balanced cleanser, moisturizing the skin when indicated and applying a protective productive product when repeated exposure to moisture is anticipated. There are many factors that influence the choice of moisturizers and protective products, however a Cochrane review of IAD in 2016 noted that there was no evidence that one product was superior to another. Currently, a single-step intervention using disposable washcloths that incorporate cleansing, protecting, and skin restoring agents into a single product (3-in-1 wipes) is widely practiced and helps to maximize adherence to best practices in the treatment and prevention of MASD.
Research has shown that a family of enzyme inhibitors can be isolated from a subset of plants. These plant-based inhibitor peptides (PBIPs) have been well characterized and have been shown to reduce the proteolytic activities of enzymes commonly seen in the digestive tract and feces. PBIPs have demonstrated anticarcinogenic activity against tumor cells in vitro, in animal models, and in human phase II clinical trials. PBIP Concentrates (PBIPCs) have the same anticarcinogenic profile as purified PBIPs and have been developed for human trials. Both PBIPs and PBIPCs are nontoxic, and safety has been reported in numerous clinical studies. Topical PBIPCs have been used safely in clinical studies as hair growth suppressant and to treat skin pigmentation.
Scotiaderm Inc. has developed Dermategrity Barrier Cream; a topical formulation of a barrier cream containing zinc oxide with PBIPCs to be used in the treatment of MASD caused by diarrhea and/or fecal incontinence. The purpose of the proposed research is to evaluate the safety, efficacy, and patient satisfaction with Dermategrity Barrier Cream for the treatment of MASD caused by fecal incontinence in an outpatient setting. The study design will compare a zinc oxide standard barrier cream to Scotiaderm's proprietary formula to determine if the plant-based extract enhances the efficacy of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomizations will be assigned by placing an equal number of control and intervention assignments into opaque envelopes. When a patient is enrolled, the research coordinator will draw an envelope, and the assignment in that envelope will be given to that patient. This process will be repeated for all patients enrolled. Patients will be enrolled until 20 patients are recruited in each study arm. The research coordinator will have a list of the randomizations; this will not be shared with the investigator, the care team, or the participants. Study product will be provided in identical, plain white tubes with labels of arm 1 (control) and arm 2 (intervention). The study coordinator will ensure that participants receive the correct product for their randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and/or fecal incontinence.
- •Able to provide written informed consent
- •Either able to self-administer barrier cream to the affected region OR administer with the assistance of a caregiver
排除标准
- •History of complex skin disorders (such as psoriasis or eczema)
- •Known allergy to any of the ingredients in the study product
- •Visual evidence of a bacterial skin infection
- •Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care.
- •Patients who are pregnant will not be excluded from the study unless they present with a rash or other skin conditions that may confound assessments
- •A medical condition that, in the opinion of the investigator, precludes the patient from being able to provide informed consent OR presents confounds which may bias the study outcomes
研究组 & 干预措施
Investigational Product
Patients randomized to the intervention arm will be treated with Dermategrity Barrier Cream.
干预措施: Dermategrity Everyday Barrier Cream (Other)
Control
Patients randomized to the control arm will be treated with a 15% zinc oxide barrier cream, which is standard of care for MASD.
干预措施: Barrier Cream (Other)
结局指标
主要结局
GLOB-IAD Clinical Assessment
时间窗: 14 days
The GLOB-IAD Clinical Assessment is the only validated clinical tool for assessing MASD. This assessment will be performed daily for the first 7 days, and once again at day 14. All GLOB-IAD assessments will be done by a qualified study team member (i.e., principle investigator, wound care nurse, etc.).
Visual Analog Scale for Erythema
时间窗: 14 Days
The Visual Analog Scale (VAS) for erythema is a visual assessment tool to measure the severity of a patient's erythema. The VAS Erythema employs a visual scale from 0 "no visible signs of erythema" to 100 "worst possible erythema", allowing the investigator to capture erythema for all skin colors and types. The VAS Erythema will be performed at baseline, day 7, and day 14.
GLOB-IAD Clinical Assessment
时间窗: 14 days
The GLOB-IAD Clinical Assessment is the only validated clinical tool for assessing MASD. This assessment will be performed daily for the first 7 days, and once again at day 14. All GLOB-IAD assessments will be done by a qualified study team member (i.e., principle investigator, wound care nurse, etc.).
Visual Analog Scale for Erythema
时间窗: 14 Days
The Visual Analog Scale (VAS) for erythema is a visual assessment tool to measure the severity of a patient's erythema. The VAS Erythema employs a visual scale from 0 "no visible signs of erythema" to 100 "worst possible erythema", allowing the investigator to capture erythema for all skin colors and types. The VAS Erythema will be performed at baseline, day 7, and day 14.
次要结局
- Safety - Adverse Events and Product-Related Adverse Effects(14 Days)
- Patient-reported Satisfaction(14 Days)
- Safety - Adverse Events and Product-Related Adverse Effects(14 Days)
- Patient-reported Satisfaction(14 Days)
- Visual Analog Scale - Symptoms(14 Days)