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

The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Device: Marketed Adhesive Bandage #1; Device: Marketed Bandage #2; Device: Non-Marketed Bandage #1; Device: Non-Marketed Bandage #2; Device: Non-Marketed Adhesive Bandage #3; Device: Non-Marketed Adhesive Bandage #4; Device: Non-Marketed Adhesive Bandage #5

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • Thomas J. Stephens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Marketed Adhesive Bandage #1; 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.	Device: Marketed Adhesive Bandage #1; On the randomized wound site, a marketed adhesive bandage will be applied.
Active Comparator: Marketed Adhesive Bandage #2; 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.	Device: Marketed Bandage #2; On the randomized wound site, a marketed adhesive bandage will be applied.
Active Comparator: Non-marketed Adhesive Bandage #1; 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.	Device: Non-Marketed Bandage #1; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #2; 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.	Device: Non-Marketed Bandage #2; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #3; 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.	Device: Non-Marketed Adhesive Bandage #3; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #4; 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.	Device: Non-Marketed Adhesive Bandage #4; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Experimental: Non-marketed Adhesive Bandage #5; 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.	Device: Non-Marketed Adhesive Bandage #5; On the randomized wound site, a non-marketed adhesive bandage will be applied.
No Intervention: No Treatment (Uncovered, Negative Control); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Change from baseline in Clinical grading of wound healing parameter (erythema) was evaluated on a scale of 0 (no erythema) to 4 (severe 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	Change from baseline in Clinical grading of wound healing parameter (edema) was evaluated on a scale of 0 (no edema) to 4 (severe 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	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.	Baseline and Day 28
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).	Baseline, Day 1, 2, 3 and 4
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).	Baseline, Day 1, 2, 3 and 4
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).	Baseline, Day 1, 2, 3 and 4
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.	Day 1, 2, 3 and 4
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.	Day 1, 2, 3 and 4

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Principal Investigator: Lily Jiang, PhD, Thomas J. Stephens & Associates, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CCSTOH001689 (Other Identifier: Johnson & Johnson Consumer Inc. (J&JCI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No