A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedStudy Start
First participant enrolled
August 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedResults Posted
Study results publicly available
February 4, 2021
CompletedJuly 3, 2023
June 1, 2023
2 months
July 30, 2019
October 16, 2020
June 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to Day 16
Secondary Outcomes (9)
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Change From Baseline in Composite Scar Score
Baseline and Day 28
Change From Baseline in Painful Score With Arm Resting by Side
Baseline, Day 1, 2, 3 and 4
- +4 more secondary outcomes
Study Arms (8)
Marketed Adhesive Bandage #1
ACTIVE COMPARATORMinor 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.
Marketed Adhesive Bandage #2
ACTIVE COMPARATORMinor 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.
Non-marketed Adhesive Bandage #1
ACTIVE COMPARATORMinor 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.
Non-marketed Adhesive Bandage #2
EXPERIMENTALMinor 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.
Non-marketed Adhesive Bandage #3
EXPERIMENTALMinor 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.
Non-marketed Adhesive Bandage #4
EXPERIMENTALMinor 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.
Non-marketed Adhesive Bandage #5
EXPERIMENTALMinor 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.
No Treatment (Uncovered, Negative Control)
NO INTERVENTIONMinor 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.
Interventions
On the randomized wound site, a marketed adhesive bandage will be applied.
On the randomized wound site, a marketed adhesive bandage will be applied.
On the randomized wound site, a non-marketed adhesive bandage will be applied.
On the randomized wound site, a non-marketed adhesive bandage will be applied.
On the randomized wound site, a non-marketed adhesive bandage will be applied.
On the randomized wound site, a non-marketed adhesive bandage will be applied.
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas J. Stephens
Richardson, Texas, 75081, United States
Results Point of Contact
- Title
- Robin Mathew
- Organization
- Johnson & Johnson Consumer Inc. (J&JCI)
Study Officials
- PRINCIPAL INVESTIGATOR
Lily Jiang, PhD
Thomas J. Stephens & Associates, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2019
First Posted
August 1, 2019
Study Start
August 9, 2019
Primary Completion
October 18, 2019
Study Completion
October 30, 2019
Last Updated
July 3, 2023
Results First Posted
February 4, 2021
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
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.