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Completed

NCT Number: NCT05824351

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

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.

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Key information

Conditions

Abdominal Site Colostomy Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Denter

Durham, North Carolina, 22210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tanzanian beeswax-pine resin

Device

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

Domestic beeswax-pine resin

Device

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

Hollister's AdaptTM Barrier Rings

Device

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

Primary outcomes

  1. Skin Irritation as Measured by Draize Score for Erythema and Edema

    Time frame: Assessed daily up to 7 days, day 7 reported

    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.

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

    Time frame: Assessed daily up to 7 days, day 7 reported

    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.

  3. Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?"

    Time frame: Assessed daily up to 7 days, day 7 reported

  4. Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks"

    Time frame: Assessed daily up to 14 days, day 14 reported

  5. Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?"

    Time frame: Assessed daily up to 7 days, day 7 reported

  6. Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week"

    Time frame: Assessed daily up to 7 days, day 7 reported

  7. Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week"

    Time frame: Assessed daily up to 7 days, day 7 reported

  8. Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week"

    Time frame: Assessed daily up to 7 days, day 7 reported

  9. Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week"

    Time frame: Assessed daily up to 7 days, day 7 reported

  10. Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body"

    Time frame: Assessed daily up to 7 days, day 7 reported

Secondary outcomes

  1. Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection

    Time frame: Assessed daily up to 7 days, day 7 reported

  2. Overall Well-being as Measured by Daily Survey

    Time frame: Daily, days 1-7

    Number of participants who responded "yes" to the question, "Have you had any major discomfort/irritation/redness/swelling caused any of the three samples?"

  3. Overall Well-being as Measured by Daily Survey

    Time frame: Daily, days 1-6

    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?"

  4. Overall Well-being as Measured by Daily Survey

    Time frame: Daily, days 1-7

    Number of participants who responded "yes" to the question, "Were any of your samples removed for longer than 20 minutes at any point today?"

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • VentureWell

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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