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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Flap Necrosis Flap Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal group

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

Group Type ACTIVE_COMPARATOR

wet compresses of povidone-iodine

Intervention Type OTHER

wet compresses of povidone-iodine

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.

Group Type EXPERIMENTAL

hyperbaric oxygen therapy and povidone-iodine wet compresses

Intervention Type 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.

Interventions

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hyperbaric 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.

Intervention Type DEVICE

wet compresses of povidone-iodine

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No