A Single-Center Pilot Study to Test the Effectiveness of the REPAIR Nitric Oxide (NO) Sensor to Record Wound Characteristic Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01
研究概览
简要总结
The purpose of this research is to evaluate the ability of a Nitric Oxide (NO) Sensor to collect NO measurement data from an open wound. Previous research suggests that NO levels may indicate the stage of healing the wound is in. This study is being done to determine if the NO Sensor can measure how much NO is in a participant's wound. The researcher will place the NO Sensor into a participant's wound to collect NO measurements for 30-60 minutes. The participant will then have 2 follow-up appointments to see how the wound heals over time.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extremity injury
- •Wound surface area 2-10 cm in diameter
- •Wound amenable to NO Sensor placement
- •Age at the time of consent ≥ 22 to ≤ 65 years
- •Cognitively able to undergo informed consent discussion and understand the study
排除标准
- •Chemotherapy
- •Preexisting immunosuppressive conditions or immunosuppression therapy
- •Active hemorrhage in the wound bed
- •Physician discretion for patients with complex medical conditions or high mortality risks
- •Patients with an active implanted device, such as a pacemaker, defibrillator, or hypoglossal or vagal nerve stimulator
- •Patients requiring a legally authorized representative (LAR) for informed consent
研究组 & 干预措施
NO Sensor
NO sensor placed into wound bed
干预措施: NO Sensor (Device)
结局指标
主要结局
Participants meet all inclusion/exclusion criteria - a minimum of 5 participants have completed Inclusion/Exclusion in CRF-01
时间窗: up to 8 weeks
All wound characteristics documented - a minimum of 5 wounds assessed by Bates-Jensen Wound Assessment Tool. And documented in CRF-03
时间窗: Day 0
NO Sensor application time > 30 minutes and < 60 minutes - a minimum of 5 wounds have NO sensor applied between 30-60 minutes and documented in CRF-04
时间窗: 60 minutes
NO Sensor applied and removed according to study specific SOPs - a minimum of 5 wounds have NO Sensor applied and removed according to study specific SOPs and documented in CRF-04
时间窗: Day 0
Assessment of wound healing during participant follow-up activities - a minimum of 5 participants have follow up wound assessments according to visit schedule and documented in CRF-05 and CRF-06
时间窗: up to 8 weeks
A follow up phone call within 72 hours and an in-person clinic visit within 2-8 weeks of NO Sensor application
次要结局
未报告次要终点
研究者
Stephen Badylak
Professor
University of Pittsburgh