A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wound Healing
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Time to Complete Wound Healing
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
Investigators
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
Outcomes
Primary Outcomes
Time to Complete Wound Healing
Time Frame: Up to Day 16
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.
Secondary Outcomes
- 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 Painful Score With Arm Resting by Side(Baseline, Day 1, 2, 3 and 4)
- 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 - 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 Itchy Score(Baseline, Day 1, 2, 3 and 4)
- Change From Baseline in Painful Score With Arm in Normal Motion(Baseline, Day 1, 2, 3 and 4)
- Number of Participants With Pain Duration With Arm Resting by Side(Day 1, 2, 3 and 4)
- Number of Participants With Pain Duration With Arm in Normal Motion(Day 1, 2, 3 and 4)