An Assessment of QuiltVent™ Pad Technology on the Healing of Induced Dermabrasion Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Time to Healing (Days)
研究概览
简要总结
This two-week study will compare the healing of minor wounds when no bandage is applied against four different types of bandages.
The study investigators will make five small wounds similar to scrapes (about a half-inch square) on the back of subjects who qualify to participate in the trial and have given informed consent. Four of the wounds will be covered by different bandages and one will be left uncovered. Participants will visit the clinic every day for 2 weeks or until all the wounds are healed (whichever comes first). At the clinic, the bandages will be removed, the doctor will score the wounds, a picture will be taken of the wounds and new bandages will be applied.
It is expected that some pain and itching will be experienced, because they are part of the normal wound healing process. Subjects will be asked about adverse events at each visit and will have the opportunity to discuss issues or concerns with the investigator or the doctor during the course of the trial. It is expected that the wounds will be completely healed within 14 days, but if not, the participant will need to return to the clinic for follow-up treatment until the wounds are completely healed.
We will see if the different bandages help with the healing of the wounds during the study.
详细描述
This study is evaluating the performance of various bandages on facilitating the healing of induced dermabrasion wounds. To qualify for this study, subjects must meet the inclusion/exclusion criteria within the protocol-specified parameters at both the screening and baseline visits. Once a subject is qualified, five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages and one wound will be left open to the air to serve as a no treatment control. Treatments and control will be randomized to application site. During this 14-day clinical study, subjects will return to the site for daily evaluations; study bandages will also be replaced daily by study personnel. Adverse events will be observed and collected by querying each subject at each visit, and during any follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to read and understand English enough to understand the nature, risk and relevance of the study, read and sign the informed consent document, and follow study instructions
- •After being completely informed about the study and being given a chance to have all questions answered, the subject has signed an informed consent document agreeing to:
- •comply with lifestyle instructions, including: limiting bandage exposure to water or sunlight, the use of lotions, creams, cosmetics or sunscreens during the study, to allow at least 2 hours between showers and scheduled visits, and the use of contraception
- •return to the clinical site for follow-up visits if the wounds are not healed by Day 14
- •Subject is determined to be an appropriate participant according to protocol-defined conditions, including among other things, Body Weight and Fitzpatrick Skin Type between I (Always burns easily, never tans) and III (Burns moderately, tans gradually)
- •In the opinion of the Investigator, participation in the trial will not compromise the subject's safety or the interpretation of study results
排除标准
- •Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator
- •Known allergies or hypersensitivity to LATEX, anesthetics, adhesive bandages, wound treatment products or any component present in the test bandages
- •Current participation in any other clinical trial or past participation in other clinical trials described in the protocol
- •Body mass index (BMI) above 35, and/or Fitzpatrick Skin Type above III
- •Pregnant, nursing or planning a pregnancy
结局指标
主要结局
Time to Healing (Days)
时间窗: within 14 days
Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.
次要结局
- Edema(within 14 days)
- Maceration(within 14 days)
- Subjective Assessment of Itch(within 14 days)
- Forced Rank Score(within 14 days)
- Erythema(within 14 days)
- Subjective Assessment of Pain(within 14 days)
- Subjective Assessment of Wound Healing(within 14 days)