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

NCT05824351 | Completed Results FDA Device

• 1 other identifier: Pro00111440
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Site; Colostomy Site

Outcome Measures

Primary Outcomes (10)

• Skin Irritation as Measured by Draize Score for Erythema and Edema

  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.

  Assessed daily up to 7 days, day 7 reported

• 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.

  Assessed daily up to 7 days, day 7 reported

• 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 Outcomes (4)

• 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

• Overall Well-being as Measured by Daily Survey

  Daily, days 1-6

• Overall Well-being as Measured by Daily Survey

  Daily, days 1-7

Study Arms (3)

Tanzanian beeswax-pine adhesive

EXPERIMENTAL

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

Domestic beeswax-pine adhesive

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

Tanzanian beeswax-pine resin DEVICE

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

Tanzanian beeswax-pine adhesive

Domestic beeswax-pine resin DEVICE

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

Domestic beeswax-pine adhesive

Hollister's AdaptTM Barrier Rings DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults with age +/\>18 years
• Recruited from Duke University
• Local community members

You may not qualify if:

• Any pre-existing skin conditions
• Skin allergies to tegaderm or other adhesive products contained within the study and control rings

Sponsors & Collaborators

• Duke University: lead
• VentureWell: collaborator

Study Sites (1)

Duke University Medical Denter

Durham, North Carolina, 22210, United States

Location

Results Point of Contact

• Title: Amy Barto, MD
• Organization: Duke University

amy.barto@duke.edu

919-684-1817

Study Officials

• Amy Barto, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 21, 2023
• Study Start: June 10, 2023
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)