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

Duke University

Status: Completed

Conditions: Colostomy Site; Abdominal Site

Treatments: Device: Tanzanian beeswax-pine resin; Device: Hollister's AdaptTM Barrier Rings; Device: Domestic beeswax-pine resin

Study type: Interventional

Funder types: Other

Identifiers

NCT05824351

Pro00111440

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Tanzanian beeswax-pine adhesive

Experimental group

Description:

Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.

Treatment:

Device: Tanzanian beeswax-pine resin

Domestic beeswax-pine adhesive

Active Comparator group

Description:

Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula.

Treatment:

Device: Domestic beeswax-pine resin

Control

Active Comparator group

Description:

Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Treatment:

Device: Hollister's AdaptTM Barrier Rings