A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Status
Completed
Conditions
Wound Healing
Treatments
Device: Marketed Bandage #2
Device: Non-Marketed Adhesive Bandage #5
Device: Non-Marketed Bandage #1
Device: Marketed Adhesive Bandage #1
Device: Non-Marketed Adhesive Bandage #3
Device: Non-Marketed Adhesive Bandage #4
Device: Non-Marketed Bandage #2
Details and patient eligibility
About
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
Enrollment
36 patients
Sex
All
Ages
25 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
36 participants in 8 patient groups
Marketed Adhesive Bandage #1
Active Comparator group
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.
Treatment:
Device: Marketed Adhesive Bandage #1
Marketed Adhesive Bandage #2
Active Comparator group
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.
Treatment:
Device: Marketed Bandage #2
Non-marketed Adhesive Bandage #1
Active Comparator group
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.
Treatment:
Device: Non-Marketed Bandage #1
Non-marketed Adhesive Bandage #2
Experimental group
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.
Treatment:
Device: Non-Marketed Bandage #2
Non-marketed Adhesive Bandage #3
Experimental group
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.
Treatment:
Device: Non-Marketed Adhesive Bandage #3
Non-marketed Adhesive Bandage #4
Experimental group
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.
Treatment:
Device: Non-Marketed Adhesive Bandage #4
Non-marketed Adhesive Bandage #5
Experimental group
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.
Treatment:
Device: Non-Marketed Adhesive Bandage #5
No Treatment (Uncovered, Negative Control)
No Intervention group
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.
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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