Efficacy of a Skin Protectant Textile for the Management of Skin Fold Conditions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Erythema
研究概览
简要总结
This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor associated with skin folds (henceforth together referred to as "skin fold conditions"). Participants will be patients with skin fold conditions, which will be treated with the SPT. Healthcare providers will apply the SPT to the participants' target areas. A given participant can have up to two target areas enrolled in the study. An independent licensed clinician with experience in identifying and treating skin fold conditions, will use photographs of the skin folds and other skin-on-skin contact areas (henceforth referred to as "target area[s]") to assess the status of erythema, maceration, denudation, and satellite lesions in the target areas when the SPT is first applied (Day 0), and on Days 1, 3, and 5, during SPT changes. The Principal Investigator (PI) or qualified designee will take photographs of the target areas and assess moisture and odor in these areas. Participants will provide their impressions of pain, itching and burning in the target area(s) on the same days as the skin fold condition photography. In addition, the study will include feedback from the Health Care Providers (HCPs) about the SPT and overall experience of the participants with the SPT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals ≥ 18 years of age.
- •Individuals who have evidence of one or more of the following skin fold conditions: erythema, maceration, denudation, satellite lesions, pain, itching, burning, moisture, and odor.
- •Individuals whose treatment plan permits assessment of the skin fold condition(s) for up to six days.
排除标准
- •Individuals whose target area(s) are being managed with topical treatments such as antibiotics, antifungals, ointments including skin protectants, anti-itch products, anoperineal dressings or absorbent pads (eg, ARD®).
- •Individuals with a known allergy or sensitivity to the ingredients in the SPT, such as the fabric or H2O2, as well as the tape that may be used to secure the SPT.
结局指标
主要结局
Erythema
时间窗: day 0, day 1, day 3
The efficacy of the SPT to improve skinfold condition of erythema over three days of treatment were assessed by third party clinicians using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation on the scale for each timepoint.
Maceration
时间窗: day 0, day 1, day 3.
The efficacy of the SPT to improve skinfold conditions of maceration over three days of treatment were assessed by third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation values from the scale for each timepoint measured.
Denudation
时间窗: day 0, day 1, and day 3.
The efficacy of the SPT to improve skinfold conditions denudation were assessed over 3 days by a third party clinician using a 5-point Likert scales, with "0" being least severe and "4" being most severe. Data is reported as the mean and standard deviation value on the scale for each timepoint measured.
Satellite Lesions
时间窗: 5 days
The efficacy of the SPT to improve skinfold conditions of satellite lesions were assessed by a third party clinician as absent or present each day over 5 days. Results for present lesions detected presented below. Data is reported as the percentage of participants identified with any satellite lesions.
Odor
时间窗: Day 0, day 1, day 3 and day 5
The efficacy of the SPT to improve skinfold conditions of odor over five days of treatment was assessed by a third party clinician as absent or present with values for present noted below. Data is presented as the percentage of participants identified with any odor at the target area for each timepoint measured.
次要结局
- Survey Responses for Moisture in the Target Area(s) on Assessment of Moisture Control.(Day 0, day 1, day 3, and day 5)
- Assessing Patient Reported Outcomes of Discomfort (Pain, Itching, Burning) Before Dressing Change(day 0, day 1, day 3)
- Patient Report of Pain Itching or Burning After Dressing Change Day 0, Day 1, and Day 3(day 0, day 1, day3)
- Did the Product Reduce Your Discomfort Assessed at Discharge Day 5(Day 5)
- The Product Dressing Was Comfortable to Wear(Day 5)
- Summary Statistics of HCP - HCP Reported Ease of Use: VAS Score 0-100 mm(End of the study on day 5)