Clinical trial NCT06811857: This Study Aims to Explore the Efficacy of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
Official title: An Exploration of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Flap Necrosis
Flap Ischemia
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The SKIN Area Score of Clavien-Dindo classification
timeFrame: 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 outcomes:
measure: NAC necrosis Degree
timeFrame: 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: Number of times for hyperbaric oxygen treatment
timeFrame: at the end of the study (at 3 month)
measure: Interval between surgery and hyperbaric oxygen treatment
timeFrame: baseline
measure: Breast-Q questionnaire
timeFrame: 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
measure: side effects of hyperbaric oxygen treatment
timeFrame: During hyperbaric oxygen therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Kun Wang Kun Wang, PhD
role: STUDY_CHAIR
References: