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

Not Applicable

Not yet recruiting

• Conditions: Flap Necrosis; Flap Ischemia

• Registration Number: NCT06811857
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study Start: 2025-01-31
• Study First Submitted QC: 2025-02-01
• Last Update Submitted: 2025-02-01
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China