N/A N=50 Supportive Care

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

Abdominal Site · Colostomy Site

Bottom Line

View on ClinicalTrials.gov: NCT05824351 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Skin Irritation as Measured by Draize Score for Erythema and Edema — 0.86; 0.03; 0; 0.38 score on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tanzanian beeswax-pine resin (Device); Domestic beeswax-pine resin (Device); Hollister's AdaptTM Barrier Rings (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Skin Irritation as Measured by Draize Score for Erythema and Edema	0.86; 0.03; 0; 0.38; 0.15; 0.44	<0.0001 sig
PRIMARY Skin Irritation as Measured by the 5-D (5-dimension) Itch Scale	—	—
PRIMARY Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?"	40; 2	—
PRIMARY Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks"	17; 20; 5	—
PRIMARY Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?"	7; 10; 4; 2; 2; 17	—
PRIMARY Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week"	37; 5	—
PRIMARY Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week"	23; 1; 2; 16	—
PRIMARY Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week"	24; 2; 0; 16	—
PRIMARY Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week"	24; 2; 0; 16	—
PRIMARY Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body"	2; 1; 39	—
SECONDARY Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection	6	—
SECONDARY Overall Well-being as Measured by Daily Survey	2; 1; 0; 2; 2; 1	—
SECONDARY Overall Well-being as Measured by Daily Survey	2; 1; 0; 2; 2; 1	—
SECONDARY Overall Well-being as Measured by Daily Survey	2; 1; 0; 2; 2; 1	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05824351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.