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

NCT ID: NCT05824351

Last Updated: 2024-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2023-06-23

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.

Detailed Description

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Conditions

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Abdominal Site Colostomy Site

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tanzanian beeswax-pine adhesive

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

Group Type EXPERIMENTAL

Tanzanian beeswax-pine resin

Intervention Type DEVICE

Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.

Domestic beeswax-pine adhesive

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

Group Type ACTIVE_COMPARATOR

Domestic beeswax-pine resin

Intervention Type DEVICE

Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.

Control

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

Group Type ACTIVE_COMPARATOR

Hollister's AdaptTM Barrier Rings

Intervention Type DEVICE

Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Interventions

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Tanzanian beeswax-pine resin

Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.

Intervention Type DEVICE

Domestic beeswax-pine resin

Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.

Intervention Type DEVICE

Hollister's AdaptTM Barrier Rings

Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VentureWell

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Barto, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Denter

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Pro00111440

Identifier Type: -

Identifier Source: org_study_id

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