Abdominal Site, Colostomy Site
Conditions
Brief 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.
Interventions
DEVICETanzanian beeswax-pine resin
Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.
DEVICEDomestic beeswax-pine resin
Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.
DEVICEHollister's AdaptTM Barrier Rings
Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Sponsors
VentureWell
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation as Measured by Survey: Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body | 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 | 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 | Assessed daily up to 7 days, day 7 reported | — |
| Skin Irritation as Measured by Draize Score for Erythema and Edema | 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 | 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? | 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 | 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? | 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 | 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 | Assessed daily up to 7 days, day 7 reported | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Well-being as Measured by Daily Survey | 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? |
| Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection | Assessed daily up to 7 days, day 7 reported | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
Baseline characteristics
| Characteristic | Tanzanian Beeswax-pine Adhesive, Domestic Beeswax-pine Adhesive, and Control |
|---|---|
| Age, Continuous | 23.8 years STANDARD_DEVIATION 6.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 50 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 6 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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.
Time frame: Assessed daily up to 7 days, day 7 reported
Population: Each participant received all three types of adhesive. Data not collected on 9 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Draize Score for Erythema and Edema | Edema | 0.86 score on a scale | Standard Deviation 0.28 |
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Draize Score for Erythema and Edema | Erythema | 0.38 score on a scale | Standard Deviation 0.65 |
| Domestic Beeswax-pine Adhesive | Skin Irritation as Measured by Draize Score for Erythema and Edema | Edema | 0.03 score on a scale | Standard Deviation 0.17 |
| Domestic Beeswax-pine Adhesive | Skin Irritation as Measured by Draize Score for Erythema and Edema | Erythema | 0.15 score on a scale | Standard Deviation 0.5 |
| Control | Skin Irritation as Measured by Draize Score for Erythema and Edema | Edema | 0 score on a scale | Standard Deviation 0 |
| Control | Skin Irritation as Measured by Draize Score for Erythema and Edema | Erythema | 0.44 score on a scale | Standard Deviation 0.66 |
Comparison: Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).p-value: <0.0001t-test, 1 sided
Comparison: Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).p-value: 0.0003t-test, 1 sided
Primary
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body | Broader Abdomen | 2 Participants |
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Mark Whether the Itching (if Any) Spread to the Following Parts of Your Body | Unchecked | 1 Participants |
| Tanzanian Beeswax-pine Adhesive | 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 |
Primary
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Over the Past Week, Has Your Itching Progressively Gotten Better or Worse? | Getting worse | 7 Participants |
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Over the Past Week, Has Your Itching Progressively Gotten Better or Worse? | Unchanged | 10 Participants |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Over the Past Week, Has Your Itching Progressively Gotten Better or Worse? | Completely resolved | 2 Participants |
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Over the Past Week, Has Your Itching Progressively Gotten Better or Worse? | Not relevant/applicable | 17 Participants |
Primary
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Please Rate the Intensity of Your Itching Over the Past Two Weeks | Not Present | 17 Participants |
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Please Rate the Intensity of Your Itching Over the Past Two Weeks | Mild | 20 Participants |
| Tanzanian Beeswax-pine Adhesive | Skin Irritation as Measured by Survey: Please Rate the Intensity of Your Itching Over the Past Two Weeks | Moderate | 5 Participants |
Primary
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
Primary
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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
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
Population: Each participant received all three types of adhesive. Data not collected on 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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 |
| Tanzanian Beeswax-pine Adhesive | 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
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.
Time frame: Assessed daily up to 7 days, day 7 reported
Population: Data not collected.
Secondary
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
Population: Each participant received all three types of adhesive. Data were collected on the whole participant level for the reported adverse events data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Number of Participants With Adverse Side Effects Such as Redness, Rash, Skin Irritation, and Infection | 6 Participants |
Secondary
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?
Time frame: Daily, days 1-7
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 1 | 0 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 2 | 0 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 3 | 0 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 6 | 0 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 7 | 2 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 4 | 0 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 5 | 1 Participants |
Secondary
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?
Time frame: Daily, days 1-6
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 1 | 44 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 2 | 44 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 3 | 43 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 4 | 42 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 5 | 42 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 6 | 44 Participants |
Secondary
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?
Time frame: Daily, days 1-7
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 1 | 2 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 2 | 1 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 3 | 0 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 4 | 2 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 5 | 2 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 6 | 1 Participants |
| Tanzanian Beeswax-pine Adhesive | Overall Well-being as Measured by Daily Survey | Day 7 | 1 Participants |