LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa

Study Overview
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Brief Summary
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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.

Official Title
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Team LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa and Other Low Resource Settings.

Conditions
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Abdominal Site, Colostomy Site

Intervention / Treatment
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* Device: Tanzanian beeswax-pine resin
* Device: Domestic beeswax-pine resin
* Device: Hollister's AdaptTM Barrier Rings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults with age +/>18 years Recruited from Duke University Local community members Exclusion Criteria: Any pre-existing skin conditions Skin allergies to tegaderm or other adhesive products contained within the study and control rings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tanzanian beeswax-pine adhesive<br>Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. | Device: Tanzanian beeswax-pine resin<br>* Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.<br>|
| Active Comparator: Domestic beeswax-pine adhesive<br>Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. | Device: Domestic beeswax-pine resin<br>* Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.<br>|
| Active Comparator: Control<br>Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. | Device: Hollister's AdaptTM Barrier Rings<br>* Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin irritation as measured by total Draize score | The total Draize score (erythema plus edema) has a range of 0 to 8, where a higher score indicated greater irritation. | 7 days | 
| Skin irritation as measured by the 5-D (5-dimension) Itch Scale | 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse side effects such as redness, rash, skin irritation, and infection | Adverse side effects of the adhesive rings placed on the skin may include redness, rash, skin irritation, and infection. | 7 days | 
| Overall well-being as measured by daily survey |  | 7 days |