CompletedNot Applicable

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

United States50 participantsStarted 2023-06-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Skin Irritation as Measured by Draize Score for Erythema and Edema

Timeframe: Assessed daily up to 7 days, day 7 reported

Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale

Timeframe: 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?"

Timeframe: 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"

Timeframe: 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?"

Timeframe: 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"

Timeframe: 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"

Timeframe: Assessed daily up to 7 days, day 7 reported

Trial details

NCT IDNCT05824351

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-23

Results submitted2024-06-21

View on ClinicalTrials.gov More Abdominal Site trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Skin Irritation as Measured by Draize Score for Erythema and Edema

Timeframe: Assessed daily up to 7 days, day 7 reported

Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale

Timeframe: 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?"

Timeframe: 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"

Timeframe: 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?"

Timeframe: 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"

Timeframe: 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"

Timeframe: Assessed daily up to 7 days, day 7 reported