Back to resultsA Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Primary Purpose
Wound Healing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marketed Adhesive Bandage #1
Marketed Bandage #2
Non-Marketed Bandage #1
Non-Marketed Bandage #2
Non-Marketed Adhesive Bandage #3
Non-Marketed Adhesive Bandage #4
Non-Marketed Adhesive Bandage #5
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing
Eligibility Criteria
Inclusion Criteria:
- Fitzpatrick Skin Type II or III
- Uniform skin color on both volar forearms
- Generally in good health based on medical history reported by the participant
- -Individual has signed the Photographic Release and Informed Consent Documents along with (HIPAA) disclosure
- Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms
Exclusion Criteria:
- Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the Investigational Products (IPs)/auxiliary/ancillary products
- Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease
- Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound study results, increase risk to participant, or interfere with study evaluations
- Has excessive hair or tattoos on either volar forearm
- Has a known history of severe systemic immune system disorders
- Has self-reported Type 1 or Type 2 diabetes
- Has self-reported uncontrolled chronic diseases
- Is taking medication that would mask an adverse event, confound study results or alter/compromise the bleeding/healing process
- Is self-reported to be pregnant or planning to become pregnant
- Has a body mass index (BMI) above 35
- Is self-reported to be an alcohol or drug abuser
- Has participated in another clinical trial within 10 days
- Either is or lives with someone who is a current employee of any company that makes/markets adhesive bandages or first-aid products
Sites / Locations
- Thomas J. Stephens
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
Marketed Adhesive Bandage #1
Marketed Adhesive Bandage #2
Non-marketed Adhesive Bandage #1
Non-marketed Adhesive Bandage #2
Non-marketed Adhesive Bandage #3
Non-marketed Adhesive Bandage #4
Non-marketed Adhesive Bandage #5
No Treatment (Uncovered, Negative Control)
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed only on Days 3, 5, 7, 9, 11, 13, 15, and 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment will be applied as the wound will be kept uncovered as negative control.
Outcomes
Primary Outcome Measures
Time to Complete Wound Healing
Time to complete wound healing: time(in days) elapsed from time of wound creation to 12 PM of day (up to Day 16) on which composite healing score(CHS) first meets complete healing criterion of being at least a score of 8 (threshold for complete healing). CHS was calculated from clinical grading of wound healing parameters as general wound appearance (0 [Poor-New or fresh wound with epithelium layer missing, wound bed appears raw and possibly oozing] to 4 [Excellent-Fully healed, skin flush against surrounding skin, slight color mismatch may be present])+smoothness (0 [Rough, uneven wound]- 4 [complete smoothness, even wound])+epithelial confluence (0 [None]- 4 [91-100%full epithelial growth]) - erythema (0 [None]- 4 [Severe]) - edema (0 [None]- 4 [Severe]) - crusting/scabbing (0 [None]- 4 [90-100% crusting/scabbing]). CHS on 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and was calculated for each wound site at each evaluation day.
Secondary Outcome Measures
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Change from Baseline in TEWL was reported. TEWL is the passive transfer of water through stratum corneum and was measured for each wound site using Tewameter TM330T. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Change from baseline in Clinical grading of wound healing parameter (erythema) was evaluated on a scale of 0 (no erythema) to 4 (severe erythema).
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Change from baseline in Clinical grading of wound healing parameter (edema) was evaluated on a scale of 0 (no edema) to 4 (severe edema).
Change From Baseline in Composite Scar Score
Change from baseline in composite scar score was reported. It was calculated as the sum of the individual parameters on the Manchester Scar Scale (Color ranges 1 [perfect] to 4 [gross mismatch]), Finish ranges 1 [matte] to 2 [shiny], Contour ranges 1 [Flush with surrounding skin] to 4 [keloid], Distortion ranges 1 [none] to 4 [severe] and Texture ranges 1 [normal] to 4 [hard]). Composite Scar Scores range from 5 to 18, with 5 representing clinically best scars and 18 representing clinically worst scars.
Change From Baseline in Painful Score With Arm Resting by Side
Change from baseline in painful score based on participants self-assessment questionnaire score (question 1) was reported. Participants were asked to rate each wound for pain/soreness in resting position as score from 0 (no pain) to 10 (severe pain).
Change From Baseline in Painful Score With Arm in Normal Motion
Change from baseline in Painful Score based on participants self-assessment questionnaire score (question 3) was reported. Participants were asked to rate each wound for pain/soreness in normal position as score from 0 (no pain) to 10 (severe pain).
Change From Baseline in Itchy Score
Change from baseline in itchy score based on participants self-assessment questionnaire score (question 5) was reported. Participants were asked to rate each wound for itchiness as score from 0 (no itch) to 10 (severe itch).
Number of Participants With Pain Duration With Arm Resting by Side
Participants were asked to rate the pain as either brief, periodic, or constant in arm resting position with the Self-Assessment Questionnaire (question 2). Number of participants with pain duration (brief, periodic, or constant) with arm resting by side was reported.
Number of Participants With Pain Duration With Arm in Normal Motion
Participants were asked to rate the pain as either brief, periodic, or constant in arm normal motion with the Self-Assessment Questionnaire (question 4). Number of participants with pain duration (brief, periodic, or constant) with arm in normal motion was reported.
Full Information
NCT ID
NCT04040933
First Posted
July 30, 2019
Last Updated
June 28, 2023
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
1. Study Identification
Unique Protocol Identification Number
NCT04040933
Brief Title
A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Official Title
A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Marketed Adhesive Bandage #1
Arm Type
Active Comparator
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Arm Title
Marketed Adhesive Bandage #2
Arm Type
Active Comparator
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed only on Days 3, 5, 7, 9, 11, 13, 15, and 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Arm Title
Non-marketed Adhesive Bandage #1
Arm Type
Active Comparator
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Arm Title
Non-marketed Adhesive Bandage #2
Arm Type
Experimental
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Arm Title
Non-marketed Adhesive Bandage #3
Arm Type
Experimental
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Arm Title
Non-marketed Adhesive Bandage #4
Arm Type
Experimental
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Arm Title
Non-marketed Adhesive Bandage #5
Arm Type
Experimental
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments.
Arm Title
No Treatment (Uncovered, Negative Control)
Arm Type
No Intervention
Arm Description
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment will be applied as the wound will be kept uncovered as negative control.
Intervention Type
Device
Intervention Name(s)
Marketed Adhesive Bandage #1
Intervention Description
On the randomized wound site, a marketed adhesive bandage will be applied.
Intervention Type
Device
Intervention Name(s)
Marketed Bandage #2
Intervention Description
On the randomized wound site, a marketed adhesive bandage will be applied.
Intervention Type
Device
Intervention Name(s)
Non-Marketed Bandage #1
Intervention Description
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Intervention Type
Device
Intervention Name(s)
Non-Marketed Bandage #2
Intervention Description
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Intervention Type
Device
Intervention Name(s)
Non-Marketed Adhesive Bandage #3
Intervention Description
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Intervention Type
Device
Intervention Name(s)
Non-Marketed Adhesive Bandage #4
Intervention Description
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Intervention Type
Device
Intervention Name(s)
Non-Marketed Adhesive Bandage #5
Intervention Description
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Primary Outcome Measure Information:
Title
Time to Complete Wound Healing
Description
Time to complete wound healing: time(in days) elapsed from time of wound creation to 12 PM of day (up to Day 16) on which composite healing score(CHS) first meets complete healing criterion of being at least a score of 8 (threshold for complete healing). CHS was calculated from clinical grading of wound healing parameters as general wound appearance (0 [Poor-New or fresh wound with epithelium layer missing, wound bed appears raw and possibly oozing] to 4 [Excellent-Fully healed, skin flush against surrounding skin, slight color mismatch may be present])+smoothness (0 [Rough, uneven wound]- 4 [complete smoothness, even wound])+epithelial confluence (0 [None]- 4 [91-100%full epithelial growth]) - erythema (0 [None]- 4 [Severe]) - edema (0 [None]- 4 [Severe]) - crusting/scabbing (0 [None]- 4 [90-100% crusting/scabbing]). CHS on 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and was calculated for each wound site at each evaluation day.
Time Frame
Up to Day 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Description
Change from Baseline in TEWL was reported. TEWL is the passive transfer of water through stratum corneum and was measured for each wound site using Tewameter TM330T. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.
Time Frame
Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Title
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Description
Change from baseline in Clinical grading of wound healing parameter (erythema) was evaluated on a scale of 0 (no erythema) to 4 (severe erythema).
Time Frame
Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Title
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Description
Change from baseline in Clinical grading of wound healing parameter (edema) was evaluated on a scale of 0 (no edema) to 4 (severe edema).
Time Frame
Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Title
Change From Baseline in Composite Scar Score
Description
Change from baseline in composite scar score was reported. It was calculated as the sum of the individual parameters on the Manchester Scar Scale (Color ranges 1 [perfect] to 4 [gross mismatch]), Finish ranges 1 [matte] to 2 [shiny], Contour ranges 1 [Flush with surrounding skin] to 4 [keloid], Distortion ranges 1 [none] to 4 [severe] and Texture ranges 1 [normal] to 4 [hard]). Composite Scar Scores range from 5 to 18, with 5 representing clinically best scars and 18 representing clinically worst scars.
Time Frame
Baseline and Day 28
Title
Change From Baseline in Painful Score With Arm Resting by Side
Description
Change from baseline in painful score based on participants self-assessment questionnaire score (question 1) was reported. Participants were asked to rate each wound for pain/soreness in resting position as score from 0 (no pain) to 10 (severe pain).
Time Frame
Baseline, Day 1, 2, 3 and 4
Title
Change From Baseline in Painful Score With Arm in Normal Motion
Description
Change from baseline in Painful Score based on participants self-assessment questionnaire score (question 3) was reported. Participants were asked to rate each wound for pain/soreness in normal position as score from 0 (no pain) to 10 (severe pain).
Time Frame
Baseline, Day 1, 2, 3 and 4
Title
Change From Baseline in Itchy Score
Description
Change from baseline in itchy score based on participants self-assessment questionnaire score (question 5) was reported. Participants were asked to rate each wound for itchiness as score from 0 (no itch) to 10 (severe itch).
Time Frame
Baseline, Day 1, 2, 3 and 4
Title
Number of Participants With Pain Duration With Arm Resting by Side
Description
Participants were asked to rate the pain as either brief, periodic, or constant in arm resting position with the Self-Assessment Questionnaire (question 2). Number of participants with pain duration (brief, periodic, or constant) with arm resting by side was reported.
Time Frame
Day 1, 2, 3 and 4
Title
Number of Participants With Pain Duration With Arm in Normal Motion
Description
Participants were asked to rate the pain as either brief, periodic, or constant in arm normal motion with the Self-Assessment Questionnaire (question 4). Number of participants with pain duration (brief, periodic, or constant) with arm in normal motion was reported.
Time Frame
Day 1, 2, 3 and 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fitzpatrick Skin Type II or III
Uniform skin color on both volar forearms
Generally in good health based on medical history reported by the participant
-Individual has signed the Photographic Release and Informed Consent Documents along with (HIPAA) disclosure
Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms
Exclusion Criteria:
Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the Investigational Products (IPs)/auxiliary/ancillary products
Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease
Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound study results, increase risk to participant, or interfere with study evaluations
Has excessive hair or tattoos on either volar forearm
Has a known history of severe systemic immune system disorders
Has self-reported Type 1 or Type 2 diabetes
Has self-reported uncontrolled chronic diseases
Is taking medication that would mask an adverse event, confound study results or alter/compromise the bleeding/healing process
Is self-reported to be pregnant or planning to become pregnant
Has a body mass index (BMI) above 35
Is self-reported to be an alcohol or drug abuser
Has participated in another clinical trial within 10 days
Either is or lives with someone who is a current employee of any company that makes/markets adhesive bandages or first-aid products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lily Jiang, PhD
Organizational Affiliation
Thomas J. Stephens & Associates, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas J. Stephens
City
Richardson
State/Province
Texas
ZIP/Postal Code
75081
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
IPD Sharing URL
http://yoda.yale.edu
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A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
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