Hyperbaric Oxygen Radiation Tissue Injury Study - I (Soft tissue radionecrosis)

Baromedical Research Foundation (USA)0 个研究点目标入组 60 人开始时间: 2008年10月17日最近更新: 2019年2月11日

适应症

试验速览

•1. Both males and females between the ages of 18 and 70 years
•2. Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria listed below:
•2.1. Endarteritis
•2.2. Hypocellularity
•2.3. Hypovascularity
•2.4. Vascular congestion
•2.5. Ulceration
•2.6. Dehiscence
•2.7. Ischemia
•2.8. Necrosis
•2.9. Skin graft failure
•2.10. Skin flap failure
•2.11. Spontaneous breakdown
•2.12. Pain
•2.13. Delayed healing
•2.14. Local Tissue Hypoxia

•1. Reactive airway disease
•2. Radiographic evidence of pulmonary blebs or bullae
•3. Untreated pneumothorax
•4. Previously documented ejection fraction less than 35%
•5. History of seizures (except childhood febrile seizures)
•6. Cardiovascular instability
•7. Mechanical ventilator support (with the exception of those patients who are immediately [1-5 days] post-operative)
•8. Unable to follow simple commands
•9. Not orientated to person, place, time
•10. Participating as a subject in any other medical or biomedical research project (If previously involved as a subject, sufficient time must have elapsed to permit wash out of any investigational agent)

发起方

Baromedical Research Foundation (USA)