Abdominal SiteNCT05824351

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

A study testing Tanzanian beeswax-pine resin, Domestic beeswax-pine resin and Hollister's AdaptTM Barrier Rings in people with Abdominal Site and Colostomy Site, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Abdominal Site, Colostomy Site
What is being tested?: Tanzanian beeswax-pine resin, Domestic beeswax-pine resin and Hollister's AdaptTM Barrier Rings
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 10 Jun 2023to 23 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Denter
Durham, North Carolina, 22210

Other trials in United States

About this study

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.

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
Being tested: Tanzanian beeswax-pine resin, Domestic beeswax-pine resin, Hollister's AdaptTM Barrier Rings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tanzanian beeswax-pine resinDevice
Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.
Domestic beeswax-pine resinDevice
Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.
Hollister's AdaptTM Barrier RingsDevice
Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Study groups in NCT05824351
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Device: Hollister's AdaptTM Barrier Rings

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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?"
Measured: 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"
Measured: 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?"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: Daily, days 1-7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202323 Jun 2023

First posted21 Apr 2023
Study start10 Jun 2023
Primary completion23 Jun 2023
Study completion23 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Abdominal SiteStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05824351
Sponsor's protocol ID: Pro00111440
Status last verified: Aug 2024
First submitted: 20 Mar 2023
Last updated: 26 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Rogers D, Peng J, Guan A, Jensen W, Alvarez J, Patel P, Herman A, Dow D, Saterbak A, Barto A. Dermatological Effects of a Beeswax-Pine Resin Mixture on Abdominal Skin: A Proof-of-Concept Study Supporting the Development of an Affordable Investigational Ostomy Pouching System in Low-Income Regions. J Wound Ostomy Continence Nurs. 2026 Sep-Oct 01;53(5):416-424. doi: 10.1097/WON.0000000000001316.
PubMed 42758164

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05824351
Acronym / sponsor ID: Pro00111440
Conditions: Abdominal Site, Colostomy Site
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: VentureWell
Study start: 10 Jun 2023 (actual)
Primary completion: 23 Jun 2023 (actual)
Study completion: 23 Jun 2023 (actual)
First posted: 21 Apr 2023 (actual)
Results: Posted 26 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Tanzanian beeswax-pine adhesive	Experimental	Device: Tanzanian beeswax-pine resinEach study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.
Domestic beeswax-pine adhesive	Active comparator	Device: Domestic beeswax-pine resinEach study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula.
Control	Active comparator	Device: Hollister's AdaptTM Barrier RingsEach study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tanzanian beeswax-pine resinThin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Device	Tanzanian beeswax-pine adhesive
Domestic beeswax-pine resinThin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Device	Domestic beeswax-pine adhesive
Hollister's AdaptTM Barrier RingsThin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.	Device	Control

Primary outcome

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.
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.
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
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
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
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
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
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
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
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

4 secondary outcomes

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
Overall Well-being as Measured by Daily Survey
Time frame: Daily, days 1-7
Overall Well-being as Measured by Daily Survey
Time frame: Daily, days 1-6
Overall Well-being as Measured by Daily Survey
Time frame: Daily, days 1-7

Results and safety

Results posted to the registry on 26 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	50	44

Primary outcome: Skin Irritation as Measured by Draize Score for Erythema and Edema

Time frame: Assessed daily up to 7 days, day 7 reported. Mean (Standard Deviation). Unit: score on a scale

Measure	Tanzanian Beeswax-pine Adhesive n = 35	Domestic Beeswax-pine Adhesive n = 35	Control n = 35
Edema	0.86 (0.28)	0.03 (0.17)	0 (0)
Erythema	0.38 (0.65)	0.15 (0.50)	0.44 (0.66)

Domestic Beeswax-pine Adhesive vs Control: Mean of paired differences: -0.2571, p <0.0001, t-test, 1 sided
Tanzanian Beeswax-pine Adhesive vs Control: Mean of paired differences: 0.0294, p = 0.0003, t-test, 1 sided

Population analysed: Each participant received all three types of adhesive. Data not collected on 9 participants.

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

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

Population analysed: Data not collected.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control n = 42
"Less than 6hrs/day"	40
"6-12 hrs/day"	2

Population analysed: Each participant received all three types of adhesive. Data not collected on 2 participants.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control n = 42
"Not Present"	17
"Mild"	20
"Moderate"	5

Population analysed: Each participant received all three types of adhesive. Data not collected on 2 participants.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control	0 of 50 (0%)	6 of 50 (12%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42758164Rogers D, Peng J, Guan A, Jensen W, Alvarez J, Patel P, Herman A, Dow D, Saterbak A, Barto A. Dermatological Effects of a Beeswax-Pine Resin Mixture on Abdominal Skin: A Proof-of-Concept Study Supporting the Development of an Affordable Investigational Ostomy Pouching System in Low-Income Regions. J Wound Ostomy Continence Nurs. 2026 Sep-Oct 01;53(5):416-424. doi: 10.1097/WON.0000000000001316.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Barto, MD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Irritation as Measured by Draize Score for Erythema and Edema (time frame: Assessed daily up to 7 days, day 7 reported). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05824351, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.