N/A
N=36
A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Wound Healing
Bottom Line
View on ClinicalTrials.gov: NCT04040933 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Time to Complete Wound Healing — 11.8; 11.9; 6.9; 10.9 Days — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Device)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Complete Wound Healing |
11.8; 11.9; 6.9; 10.9; 5.1; 12.9 | <0.001 sig |
| SECONDARY Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements |
39.27; 37.99; 39.57; 40.71; 39.06; 36.47 | 0.860 |
| SECONDARY Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema |
1.04; 1.06; 1.08; 1.08; 1.07; 1.07 | 0.259 |
| SECONDARY Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema |
0.22; 0.21; 0.22; 0.22; 0.26; 0.28 | >0.999 |
| SECONDARY Change From Baseline in Composite Scar Score |
2.09; 0.61; 0.33; 0.42; 0.24; 0.30 | <0.001 sig |
| SECONDARY Change From Baseline in Painful Score With Arm Resting by Side |
-0.61; -0.32; -0.46; -0.46; -0.43; -0.54 | 0.666 |
| SECONDARY Change From Baseline in Painful Score With Arm in Normal Motion |
-0.46; -0.14; -0.29; -0.32; -0.29; -0.32 | 0.761 |
| SECONDARY Change From Baseline in Itchy Score |
-0.18; -0.21; -0.32; -0.43; -0.36; -0.25 | 0.019 sig |
| SECONDARY Number of Participants With Pain Duration With Arm Resting by Side |
18; 21; 20; 21; 20; 19 | — |
| SECONDARY Number of Participants With Pain Duration With Arm in Normal Motion |
18; 20; 20; 21; 19; 20 | — |
Summary
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
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
Data sourced from ClinicalTrials.gov (NCT04040933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.