A 16-Day, Single-Center, Randomized, Comparator-Controlled Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Composite Healing Score
研究概览
简要总结
The purpose of this study is to evaluate the healing rates of wounds treated with various wound care regimens including antiseptic wound wash, topical antibiotic treatment, adhesive bandages, and/or hydrocolloid 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
- Double (Participant, 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 I to III
- •Uniform skin color on both volar forearms
- •Generally in good health based on medical history reported by the participant, and as verified by the Principal Investigator (PI) assessment and brief interview of medical history
- •Able to read, write, speak, and understand English
- •Individual must be able to understand the nature, risk, and relevance of the study
- •Individual has signed the Consent for Photograph Release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure after the nature of the study has been fully explained
- •Willing to undergo topical anesthetic and laser wound treatment on the volar forearms
- •Individual must agree to attend all required study visits, cooperate/follow all study instructions, and participate with all the procedures for the duration of the study and return to the clinical site for all scheduled visits as required by the investigator
- •Willing to wear long sleeves when going outdoors during the study to protect the test areas from exposure to sunlight. Individuals must agree to avoid exposing their forearms to sunlight (including tanning booths) throughout the entire study period
- •Individual must agree not to immerse their bandages in water for the duration of the study. Participants will only be allowed to shower during the course of the study (no swimming, baths, hot tubs, Et cetera [etc.]) Individuals must agree not to shower within 2 hours prior to each scheduled visit
- •Individuals must agree not to use lotions, creams, moisturizers, cosmetics, or sunscreens on their forearms (sites of wounds) for the entire duration of the study
- •Individuals must agree to refrain from the use of any daily cleanser or washoff products other than the auxiliary cleanser that will be provided at screening (that is, [Day -7 to Day -3]), for use on forearms throughout the study
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, cardiovascular, hepatic, or kidney disease
- •Presents with a known history of keloid or hypertrophic scar formation, cracked or excoriated skin, clinical infected skin lesions, or other skin problems that would in the opinion of the PI or Study Physician, confound the study results, increase risk to the participant, or interfere with study evaluations (example, active psoriasis anywhere on the body, seborrheic dermatitis, atopic dermatitis, other skin dermatoses, etc.)
- •Has excessive hair, acne, scars, pigmentation, tattoos, or friable skin on either volar forearm that could interfere with evaluations or study procedures (at the discretion of the PI)
- •Has a known history of severe systemic immune system disorders such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Scleroderma, chronic connective tissue disorders, Poly Arteritis Nodosa, or immunodeficiency, including human immunodeficiency viruses (HIV) infection
- •Has a history of a confirmed Coronavirus Disease 2019 (COVID-19) infection within 30 days prior to Visit 1
- •Has had contact with a COVID-19 infected person within 14 days prior to Visit 1
- •Individual or a member of the individual's household who has traveled internationally within 14 days prior to Visit 1
- •Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: a) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches) conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness; b) Temperature greater than or equal to (>=) 37.2 degree Celsius (°C)/99.5 degree Fahrenheit (°F), measured; c) Use of fever reducers within 2 days prior to each on-site study visit
- •Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
- •Has self-reported uncontrolled chronic diseases such as hypertension, hyperthyroidism, hypothyroidism, or active or recently treated (within 1 year) skin cancer, or those in known poor nutritional status
- •Is taking a medication that would mask an Adverse Event (AE), confound the study results, or alter or compromise the bleeding/healing process including: a) Antibiotics, oral corticosteroids, immunosuppressive agents, anti-coagulants, antiplatelet drugs, cytotoxic agents, continuous aspirin therapy, chemotherapy, or daily medications for chronic asthma, within 1 month before Visit 1; b) Non-steroidal anti-inflammatory drugs or steroidal drugs within 5 days before Visit
- •Low dose aspirin (81 milligrams [mg] per day) is allowed; c) Antihistamines within 2 weeks before Visit 1
- •Is self-reported to be pregnant, lactating or planning to become pregnant during the study
- •Has taken/used (oral or topical) vitamin A derivatives such as Accutane, isotretinoin, or retinoic acid within the past 1 year, or using topical Vitamin A derivatives on the forearms in the 3 weeks prior to Visit
- •Has used topical leave-on products on the volar forearms within 1 week prior to Visit 1
- •Is participating or has participated in 1) any clinical trial involving a topical or systemic investigational drug within 30 days prior to Visit 1 or 2) any other clinical study within 10 days prior to Visit 1
- •Has a body mass index (BMI) above 35 on the BMI scale. BMI will be calculated using height and weight measurements obtained by trained study personnel
- •Is self-reported to be an alcohol or drug abuser, or with any other known severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the PI, would make the participant inappropriate for entry into this study
- •Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
- •Has a relative, partner, or staff of any clinical research site personnel, or either is or lives with someone who is a current employee of any company that makes or markets adhesive bandages or first aid products
- •Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study or viewed by the PI as not being able to complete the study
研究组 & 干预措施
Treatment B: Standard of Care (SoC) Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, SoC adhesive bandage will be applied. This treatment will be changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: SoC Adhesive Bandage (Device)
Treatment C: Antibiotic Ointment
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antibiotic ointment will be applied. This treatment will be applied daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: Antibiotic Ointment (Drug)
Treatment D: Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: SoC Adhesive Bandage (Device)
Treatment D: Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: Antibiotic Ointment (Drug)
Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 0 through Day 2 and all wound sites will be uncovered after Day 3 to Day 16 for assessments.
干预措施: SoC Adhesive Bandage (Device)
Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 0 through Day 2 and all wound sites will be uncovered after Day 3 to Day 16 for assessments.
干预措施: Antibiotic Ointment (Drug)
Treatment E: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 0 through Day 2 and all wound sites will be uncovered after Day 3 to Day 16 for assessments.
干预措施: Antiseptic Wash (Drug)
Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: SoC Adhesive Bandage (Device)
Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: Antibiotic Ointment (Drug)
Treatment F: Antiseptic Wash Plus Antibiotic Ointment Plus SoC Adhesive Bandage
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, antiseptic wash plus antibiotic ointment plus SoC adhesive bandage will be applied. This treatment will be applied and changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: Antiseptic Wash (Drug)
Treatment G: Hydrocolloid Pad
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, hydrocolloid pad will be applied. This treatment will be changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: Hydrocolloid Pad (Device)
Treatment H: Hydrocolloid Pad
Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, hydrocolloid pad will be applied. This treatment will be changed daily from Day 1 through Day 6 and all wound sites will be uncovered from Day 7 to Day 16 for assessments.
干预措施: Hydrocolloid Pad (Device)
结局指标
主要结局
Composite Healing Score
时间窗: Day 16
Composite healing score will be calculated from clinical grading of wound healing parameters as (general wound appearance score + smoothness score + epithelial confluence score) - (erythema score + edema score + crusting/scabbing score). Composite healing score on a 25-point scale (-12 \[no healing\] to +12 \[towards healing\]) is indicative of extent of wound healing and will be calculated for each wound site at each evaluation day.
次要结局
- Clinical Grading of Wound Healing of Erythema(Day 0 through Day 7, Day 16)
- Clinical Grading of Wound Healing of Edema(Day 0 through Day 7, Day 16)
- Clinical Grading of Wound Healing of General Wound Appearance(Day 0 through Day 7, Day 16)
- Clinical Grading of Wound Healing of Smoothness(Day 0 through Day 7, Day 16)
- Clinical Grading of Wound Healing of Epithelial Confluence(Day 0 through Day 7, Day 16)
- Clinical Grading of Wound Healing of Crusting/Scabbing(Day 0 through Day 7, Day 16)
- Wound Healing Process Assessment Score(Day 16)
- Painful Score with Arm Resting by Side (Participant's Self-assessment Questionnaire)(Day 0 through Day 7, Day 16)
- Pain Duration with Arm Resting by Side (Participant's Self-assessment Questionnaire)(Day 0 through Day 7, Day 16)
- Painful Score with Arm in Normal Motion (Participant's Self-assessment Questionnaire)(Day 0 through Day 7, Day 16)
- Pain Duration with Arm in Normal Motion (Participant's Self-assessment Questionnaire)(Day 0 through Day 7, Day 16)
- Itchy Score of Wound Site (Participant's Self-assessment Questionnaire)(Day 0 through Day 7, Day 16)