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Colostomy Appliance

Tanzanian beeswax-pine adhesive for Colostomy

N/A

Waitlist Available

Led By Amy Barto, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Study Summary

This trial looks at the safety of an adhesive used on medical appliances to stick to the skin.

Eligible Conditions

Abdominal Pain
Colostomy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Skin irritation as measured by the 5-D (5-dimension) Itch Scale

Skin irritation as measured by total Draize score

Secondary outcome measures

Number of participants with adverse side effects such as redness, rash, skin irritation, and infection

Overall well-being as measured by daily survey

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Tanzanian beeswax-pine adhesiveExperimental Treatment1 Intervention

Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.

Group II: Domestic beeswax-pine adhesiveActive Control1 Intervention

Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula.

Group III: ControlActive Control1 Intervention

Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tanzanian beeswax-pine resin

2023

N/A

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,365 Previous Clinical Trials

3,420,594 Total Patients Enrolled

VentureWellUNKNOWN

2 Previous Clinical Trials

13 Total Patients Enrolled

Amy Barto, MDPrincipal InvestigatorDuke University

Media Library

LowCostomy Domestic Beeswax-Pine Resin (Colostomy Appliance) Clinical Trial Eligibility Overview. Trial Name: NCT05824351 — N/A

Colostomy Research Study Groups: Domestic beeswax-pine adhesive, Control, Tanzanian beeswax-pine adhesive

Colostomy Clinical Trial 2023: LowCostomy Domestic Beeswax-Pine Resin Highlights & Side Effects. Trial Name: NCT05824351 — N/A

LowCostomy Domestic Beeswax-Pine Resin (Colostomy Appliance) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05824351 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this clinical investigation accessible to those who are interested in participating?

"Affirmative. The data present on clinicaltrials.gov attests to the ongoing recruitment of participants for this medical study, which was originally posted on June 10th 2023 and most recently updated on June 23rd 2023. 50 individuals are sought across one research site."

Answered by AI

How many individuals have been consented to participate in this medical research?

"Yes, this study is still recruiting. As indicated on clinicaltrials.gov, the experiment was initially posted on June 10th 2023 and recently updated on June 23rd 2023; 50 participants are required from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824351.