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

Colostomy Site Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824351
• Other study ID #: Pro00111440
• Status: Completed
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: June 23, 2023

Study information

• Verified date: September 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colostomy Site

Intervention

Device:
• Tanzanian beeswax-pine resin
Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.
• Domestic beeswax-pine resin
Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.
• Hollister's AdaptTM Barrier Rings
Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Locations

Country	Name	City	State
United States	Duke University Medical Denter	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	VentureWell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Overall well-being as measured by daily survey		7 days