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The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyperbaric oxygen group | Experimental | 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. |
|
| Normal group | Active Comparator | The control group is given wet compresses of povidone-iodine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric oxygen therapy and povidone-iodine wet compresses | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun wang, PhD | Contact | 86+15989223200 | gzwangkun@126.com | |
| Kun Wang | Contact | gzwangkun@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Kun Wang Kun Wang, PhD | Guangdong Provincial People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
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| wet compresses of povidone-iodine | Other | wet compresses of povidone-iodine |
|
| Interval between surgery and hyperbaric oxygen treatment | baseline |
| Breast-Q questionnaire | 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. | 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 |
| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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