Effects of HBOT for Edema/Ecchymosis After Upper Eyelid Blepharoplasty (Single Site Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- A measureable reduction of ecchymosis grade in treatment group vs. control group
研究概览
简要总结
The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen; 2.0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST) (patient's breathing room air; 2.0 ATA; 90 minute exposure) in reducing edema and ecchymosis. HBOT will be applied as a single pre-operative and a single post-operative treatment for patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT 2-4 hours prior to undergoing surgery, 2-4 hours post-surgery and healing will be assessed at day 3, 10, 21, 30 & 90 days after surgery. Edema and ecchymosis will be assessed in a time series to determine the extent that HBOT reduces these clinical signs. The primary null hypothesis to test will be that no differences in scores will exist between treatment and control at day 3, 10 & 21 post-surgery. A secondary null hypothesis to test is the time required to change a score will be no different between the two groups.
HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that are able to undergo surgery at the Allure Clinic are capable of undergoing exposure to HBOT, as the contraindications of HBOT are similar to eyelid surgery, with few exceptions.
排除标准
- •The investigators will exclude active smokers and those who have quit smoking in the last 12 months, those with known lung disease, seizure disorder, congestive heart failure, known active cancer, previous treatment with specific chemotherapy agents (Doxorubicin, Bleomycin, Disulfiram, Cis-platinum, Mafenide acetate), those who cannot undergo pressurization/ depressurization because of eustachian-tube dysfunction and confinement anxiety.
研究组 & 干预措施
Hyperbaric oxygen therapy
We propose to study the effects of two HBOT treatments (one before and one after surgery) with patients who have undergone upper eyelid surgery. Reduction in swelling and bruising will be assessed at 3, 10, 21, 30 and 90 days post-surgery to determine if healing is accelerated by HBOT. Patients that volunteer to participate in this study will be exposed to two treatments of 100% oxygen at 2.0 atmospheres absolute (ATA) or air (sham) 1.2 ATA inside mono-place chambers for 90 minutes. By comparing oxygen treatment groups with a matched control group, we can accurately assess the effectiveness of this treatment for patients. By participating in this study, patients will help in establishing the best treatment practices of using HBOT to accelerate healing and reduce cost in surgical recovery.
干预措施: Hyperbaric oxygen treatment (Drug)
Air sham
We propose to study the effects of two HBOT treatments (one before and one after surgery) with patients who have undergone upper eyelid surgery. Reduction in swelling and bruising will be assessed at 3, 10, 21, 30 and 90 days post-surgery to determine if healing is accelerated by HBOT. Patients that volunteer to participate in this study will be exposed to two treatments of 100% oxygen at 2.0 atmospheres absolute (ATA) or air (sham) 1.2 ATA inside mono-place chambers for 90 minutes. By comparing oxygen treatment groups with a matched control group, we can accurately assess the effectiveness of this treatment for patients. By participating in this study, patients will help in establishing the best treatment practices of using HBOT to accelerate healing and reduce cost in surgical recovery.
干预措施: Air sham (Drug)
结局指标
主要结局
A measureable reduction of ecchymosis grade in treatment group vs. control group
时间窗: 21 days
Ecchymosis will be assessed in a time series to determine the extent that HBOT reduces these clinical signs. The primary null hypothesis to test will be that no differences in scores will exist between treatment and control at day 3, 10 \& 21 post-surgery.
次要结局
- A measureable reduction of edema grade in treatment group vs. control group(21 days)