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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Thin ring of adhesive in the form of a Tanzanian beeswax-pine resin formula.
Thin ring of adhesive in the form of a domestic beeswax-pine resin formula.
Thin ring of adhesive in the form of Hollister's AdaptTM Barrier Rings.
Duke University Medical Denter
Durham, North Carolina, United States
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
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
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"
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
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
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
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