This Study Aims to Explore the Efficacy of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Not yet enrolling

Conditions: Flap Ischemia; Flap Necrosis

Treatments: Other: wet compresses of povidone-iodine; Device: hyperbaric oxygen therapy and povidone-iodine wet compresses

Study type: Interventional

Funder types: Other

Identifiers

NCT06811857

KY2024-1048-03

Details and patient eligibility

About

The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery.

Full 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.

Enrollment: 76 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

hyperbaric oxygen group

Experimental group

Description:

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.

Treatment:

Device: hyperbaric oxygen therapy and povidone-iodine wet compresses

Normal group

Active Comparator group

Description:

The control group is given wet compresses of povidone-iodine.

Treatment:

Other: wet compresses of povidone-iodine