NCT04041908终止不适用
Observation of the Use of a Medical Food in Older Adults Undergoing Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Product Compliance
研究概览
简要总结
Multi-center, prospective, one arm study to evaluate the addition of a medical food to the standard of care in elderly adults undergoing a surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is scheduled to have non-melanoma skin cancer on either the head, leg, trunk and arm removed with final wound size of 1.0 to < 5.0 cm in diameter or with 1.0 < 5.0 cm long axis if not circular that will be healed by secondary intent
- •Participant has an acceptable state of health and nutrition
- •Participant agrees not to begin taking any new medications, dietary supplements, or alternative therapies during the study period
- •Participant is interested in participating in the study, willing to comply with the study protocol, and willing to consume two servings of drink mix per day according to the protocol
- •Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability (HIPAA) authorization prior to any study participation
排除标准
- •Participant has a disease or condition that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the participant with study visits/procedures
- •Participant has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- •Participant has known immunosuppression
- •Participant has platelet or coagulation disorders
- •Therapy with another investigational agent within 30 days of Visit 1 that has not been approved
- •Systemic infection at the time of enrollment in the study
- •Currently receiving or have received recombinant human platelet-derived growth factor or similar therapies, or other bioengineered tissue therapy within the previous 4 weeks
- •Participant has an allergy or intolerance to any ingredient in the study product
- •Participant is taking nutritional supplement(s)/capsules/formulas for wound healing and is unwilling to discontinue therapy for the duration of the study
- •Participation in another clinical study
结局指标
主要结局
Product Compliance
时间窗: Study Day 1 to Study Day 30
Percent of required study product intake from subject completed intake questionnaire
次要结局
- Investigator Wound Assessment(Study Day 1 to Study Day 30)
- Participant Wound Assessment Questionnaire(Study Day 14 and Study Day 30)
研究者
研究点 (2)
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