An interventional study of hyperbaric oxygen therapy and povidone-iodine wet compresses and wet compresses of povidone-iodine in Flap Necrosis and Flap Ischemia, sponsored by Guangdong Provincial People's Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment
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.
545 studies on the registry are indexed under Ischemia; 72 are open to participants now.
This study's planned enrollment of 76 is close to the median of 74 across 356 interventional studies indexed under Ischemia.
Browse Ischemia studies →Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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Contraindication
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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.
Device: hyperbaric oxygen therapy and povidone-iodine wet compresses
The control group is given wet compresses of povidone-iodine.
Other: wet compresses of povidone-iodine
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.
wet compresses of povidone-iodine
The SKIN Area Score of Clavien-Dindo classification
Time frame: 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
NAC necrosis Degree
Time frame: 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
Time frame: at the end of the study (at 3 month)
Interval between surgery and hyperbaric oxygen treatment
Time frame: 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.
Time frame: 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
Time frame: During hyperbaric oxygen therapy
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Jan 2026, 12 months later.
Of 71 non-industry interventional studies with no phase under Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 82 studies reached it within 33 months; a quarter within 16 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital →