Clinical trial NCT05824351: LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Site
Colostomy Site
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: VentureWell
First posted: 2023-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Skin Irritation as Measured by Draize Score for Erythema and Edema
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?"
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks"
timeFrame: Assessed daily up to 14 days, day 14 reported
measure: Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?"
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week"
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week"
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week"
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week"
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body"
timeFrame: Assessed daily up to 7 days, day 7 reported
Secondary outcomes:
measure: Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection
timeFrame: Assessed daily up to 7 days, day 7 reported
measure: Overall Well-being as Measured by Daily Survey
timeFrame: Daily, days 1-7
measure: Overall Well-being as Measured by Daily Survey
timeFrame: Daily, days 1-6
measure: Overall Well-being as Measured by Daily Survey
timeFrame: Daily, days 1-7
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Denter
state: North Carolina
Study officials:
affiliation: Duke University
name: Amy Barto, MD
role: PRINCIPAL_INVESTIGATOR
References: