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

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

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.

Study Overview

• Status: Completed
• Conditions: Colostomy Site; Abdominal Site
• Intervention / Treatment: Device: Tanzanian beeswax-pine resin; Device: Domestic beeswax-pine resin; Device: Hollister's AdaptTM Barrier Rings

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 22210
      • Duke University Medical Denter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Tanzanian beeswax-pine resin; Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.
Active Comparator: 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.	Device: Domestic beeswax-pine resin; Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.
Active Comparator: Control; 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; Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Number of participants who responded "yes" to the question, "Have you had any major discomfort/irritation/redness/swelling caused any of the three samples?"	Daily, days 1-7
Overall Well-being as Measured by Daily Survey	Number of participants who responded "yes" to the question, "Were you able to successfully remove and reattach all three samples + Tegaderm (the clear adhesive) today?"	Daily, days 1-6
Overall Well-being as Measured by Daily Survey	Number of participants who responded "yes" to the question, "Were any of your samples removed for longer than 20 minutes at any point today?"	Daily, days 1-7

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: VentureWell
• Investigators: Principal Investigator: Amy Barto, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Actual): June 23, 2023
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Platelet Aggregation Inhibitors; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Antioxidants; Pycnogenols; Propolis
• Other Study ID Numbers: Pro00111440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes