LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa
- Conditions
- Colostomy SiteAbdominal Site
- Interventions
- Device: Domestic beeswax-pine resinDevice: Hollister's AdaptTM Barrier RingsDevice: Tanzanian beeswax-pine resin
- Registration Number
- NCT05824351
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to examine the safety of the LowCostomy appliance's peristomal adhesive interface composed of a mix of beeswax and pine resin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Healthy adults with age +/>18 years
- Recruited from Duke University
- Local community members
- Any pre-existing skin conditions
- Skin allergies to tegaderm or other adhesive products contained within the study and control rings
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Domestic beeswax-pine adhesive Domestic beeswax-pine resin Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control Hollister's AdaptTM Barrier Rings Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Tanzanian beeswax-pine adhesive Tanzanian beeswax-pine resin Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.
- Primary Outcome Measures
Name Time Method Skin Irritation as Measured by Draize Score for Erythema and Edema Assessed daily up to 7 days, day 7 reported The Draize score (for each erythema and edema) has a range of 0 to 4, where a higher score indicated greater irritation. Individual scores below 3 were classified as not severe.
Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale Assessed daily up to 7 days, day 7 reported The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the itching. The score ranges from 5 to 25, where a higher score indicates greater itching.
Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?" Assessed daily up to 7 days, day 7 reported Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks" Assessed daily up to 14 days, day 14 reported Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" Assessed daily up to 7 days, day 7 reported Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week" Assessed daily up to 7 days, day 7 reported Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week" Assessed daily up to 7 days, day 7 reported Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week" Assessed daily up to 7 days, day 7 reported Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week" Assessed daily up to 7 days, day 7 reported Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body" Assessed daily up to 7 days, day 7 reported
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection Assessed daily up to 7 days, day 7 reported Overall Well-being as Measured by Daily Survey Daily, days 1-7 Number of participants who responded "yes" to the question, "Were any of your samples removed for longer than 20 minutes at any point today?"
Trial Locations
- Locations (1)
Duke University Medical Denter
🇺🇸Durham, North Carolina, United States