Trial Outcomes & Findings for LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa (NCT NCT05824351)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Assessed daily up to 7 days, day 7 reported

Results posted on

2024-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Overall Study STARTED	50
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Overall Study Adverse Event	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control n=50 Participants Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Age, Continuous	23.8 years STANDARD_DEVIATION 6.84 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=35 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive n=35 Participants Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control n=35 Participants Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Draize Score for Erythema and Edema Edema	0.86 score on a scale Standard Deviation 0.28	0.03 score on a scale Standard Deviation 0.17	0 score on a scale Standard Deviation 0
Skin Irritation as Measured by Draize Score for Erythema and Edema Erythema	0.38 score on a scale Standard Deviation 0.65	0.15 score on a scale Standard Deviation 0.50	0.44 score on a scale Standard Deviation 0.66

PRIMARY outcome

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

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?" "Less than 6hrs/day"	40 Participants	—	—
Skin Irritation as Measured by Survey: "During the Last Week, How Many Hours a Day Have You Been Itching?" "6-12 hrs/day"	2 Participants	—	—

PRIMARY outcome

Timeframe: Assessed daily up to 14 days, day 14 reported

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks" "Not Present"	17 Participants	—	—
Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks" "Mild"	20 Participants	—	—
Skin Irritation as Measured by Survey: "Please Rate the Intensity of Your Itching Over the Past Two Weeks" "Moderate"	5 Participants	—	—

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" "Getting worse"	7 Participants	—	—
Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" "Unchanged"	10 Participants	—	—
Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" "Little bit better, but still present"	4 Participants	—	—
Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" "Much better, but still present"	2 Participants	—	—
Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" "Completely resolved"	2 Participants	—	—
Skin Irritation as Measured by Survey: "Over the Past Week, Has Your Itching Progressively Gotten Better or Worse?" "Not relevant/applicable"	17 Participants	—	—

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week" "Never affects sleep"	37 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on SLEEP Over the Last Week" "Occasional delays in falling asleep"	5 Participants	—	—

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week" "Occasionally affects this activity"	2 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week" "Not relevant/applicable"	16 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week" "Never affects this activity"	23 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on LEISURE/SOCIAL ACTIVITIES Over the Last Week" "Rarely affects this activity"	1 Participants	—	—

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week" "Never affects this activity"	24 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week" "Rarely affects this activity"	2 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week" "Occasionally affects this activity"	0 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on HOUSEWORK/ERRANDS Over the Last Week" "Not relevant/applicable"	16 Participants	—	—

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week" "Never affects this activity"	24 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week" "Rarely affects this activity"	2 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week" "Occasionally affects this activity"	0 Participants	—	—
Skin Irritation as Measured by Survey: "Rate the Impact of Your Itching (if Any) on WORK/SCHOOL Over the Last Week" "Not relevant/applicable"	16 Participants	—	—

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=42 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body" "Broader Abdomen"	2 Participants	—	—
Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body" "Unchecked"	1 Participants	—	—
Skin Irritation as Measured by Survey: "Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body" "Not relevant/applicable"	39 Participants	—	—

SECONDARY outcome

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

Population: Each participant received all three types of adhesive. Data were collected on the whole participant level for the reported adverse events data.

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=50 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection	6 Participants	—	—

SECONDARY outcome

Timeframe: Daily, days 1-7

Population: Participants with data collected at each timepoint.

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=44 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Overall Well-being as Measured by Daily Survey Day 4	0 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 5	1 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 6	0 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 7	2 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 1	0 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 2	0 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 3	0 Participants	—	—

SECONDARY outcome

Timeframe: Daily, days 1-6

Population: Participants with data collected at each timepoint.

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?"

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=44 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Overall Well-being as Measured by Daily Survey Day 1	44 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 2	44 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 3	43 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 4	42 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 5	42 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 6	44 Participants	—	—

SECONDARY outcome

Timeframe: Daily, days 1-7

Population: Participants with data collected at each timepoint.

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

Outcome measures

Outcome measures
Measure	Tanzanian Beeswax-pine Adhesive n=44 Participants Each study subject will be tested with a thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.	Domestic Beeswax-pine Adhesive Each study subject will be tested with a thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.	Control Each study subject will be tested with a thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings. Hollister's AdaptTM Barrier Rings: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Overall Well-being as Measured by Daily Survey Day 1	2 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 2	1 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 3	0 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 4	2 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 5	2 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 6	1 Participants	—	—
Overall Well-being as Measured by Daily Survey Day 7	1 Participants	—	—

Adverse Events

Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control n=50 participants at risk Each study subject will be tested with thin rings of three types of adhesive. Tanzanian beeswax-pine resin: Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula. Domestic beeswax-pine resin: Thin ring of adhesive in the form of a domestic beeswax-pine resin formula. Control: Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Skin and subcutaneous tissue disorders Skin redness/irritation	12.0% 6/50 • Up to 7 days Each participant received all three types of adhesive. Data were collected on the whole participant level for the reported adverse events data.

Additional Information

Amy Barto, MD

Duke University

Phone: 919-684-1817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place