A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Time to Complete Wound Healing
研究概览
简要总结
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time to Complete Wound Healing
时间窗: 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.
次要结局
- 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)