Flap Ischemia, Flap Necrosis
Conditions
Brief summary
The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery.
Detailed description
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.
Interventions
DEVICEhyperbaric oxygen therapy and povidone-iodine wet compresses
The hyperbaric oxygen group receives 30-40 sessions of hyperbaric oxygen therapy (100% oxygen at a pressure of 2.0 ATA) and povidone-iodine wet compresses.
OTHERwet compresses of povidone-iodine
wet compresses of povidone-iodine
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. understand the study procedure, participate in the study voluntarily and sign the informed consent form 2. aged ≥ 18 years and ≤ 60 years, female 3. ECOG 0-2 4. 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；
Exclusion criteria
1. 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). 2. Pregnancy or lactation. 3. any other condition that the investigators think the patient is unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The SKIN Area Score of Clavien-Dindo classification | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of times for hyperbaric oxygen treatment | at the end of the study (at 3 month) | — |
| 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 | The BREAST-Q is a rigorously developed patient-reported outcome measure (PROM) designed to evaluate outcomes among women undergoing different types of breast surgery from the patient perspective. |
| side effects of hyperbaric oxygen treatment | During hyperbaric oxygen therapy | — |
Countries
China
Contacts
Primary ContactKun wang, PhD
Backup ContactKun Wang
Outcome results
None listed