A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the wound healing efficacy (time to complete healing) 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

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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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