An Exploration of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The SKIN Area Score of Clavien-Dindo classification
研究概览
简要总结
The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery.
详细描述
Hyperbaric oxygen is commonly used to improve tissue oxygen saturation rescue flap ischemia, and treatment of diabetic foot ulcers. In the current study, there are also a number of case reports attempting to explore the role of hyperbaric oxygen in the treatment of postoperative skin flaps and nipple areola necrosis after breast surgery and significant efficacy has been obtained. Our study expects to use the treatment of hyperbaric oxygen to save patients with signs of flap ischemic necrosis after breast cancer surgery and to improve the quality of life and prognosis of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •understand the study procedure, participate in the study voluntarily and sign the informed consent form
- •aged ≥ 18 years and ≤ 60 years, female
- •patients with The SKIN Score Degree of B-D and The SKIN area of 1-3 in the Clavien-Dindo classification after breast cancer surgery；
排除标准
- •Contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (Eustachian tube dysfunction, recurrent episodes of vertigo), eye disease (retinal detachment).
- •Pregnancy or lactation.
- •any other condition that the investigators think the patient is unsuitable for participation in the study
研究组 & 干预措施
hyperbaric oxygen group
The hyperbaric group is given a total of 30-40 sessions of hyperbaric oxygen therapy (100% oxygen at a pressure of 2.0 ATA) and povidone-iodine wet compresses.
干预措施: hyperbaric oxygen therapy and povidone-iodine wet compresses (Device)
Normal group
The control group is given wet compresses of povidone-iodine.
干预措施: wet compresses of povidone-iodine (Other)
结局指标
主要结局
The SKIN Area Score of Clavien-Dindo classification
时间窗: At baseline, weekly during HBO treatment (up to 8 weeks), 2 weeks after the end of HBO treatment, 4 weeks after the end of HBO treatment
次要结局
- Number of times for hyperbaric oxygen treatment(at the end of the study (at 3 month))
- NAC necrosis Degree(At baseline, weekly during HBO treatment (up to 8 weeks), 2 weeks after the end of HBO treatment, 4 weeks after the end of HBO treatment)
- Interval between surgery and hyperbaric oxygen treatment(baseline)
- Breast-Q questionnaire(At baseline, end of hyperbaric oxygen treatment(at 6-8 weeks), 2 weeks after end of hyperbaric oxygen treatment, 4 weeks after end of hyperbaric oxygen treatment)
- side effects of hyperbaric oxygen treatment(During hyperbaric oxygen therapy)
研究者
Kun Wang
Professor
Guangdong Provincial People's Hospital