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

ConditionsFlap NecrosisFlap Ischemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorGuangdong Provincial People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

understand the study procedure, participate in the study voluntarily and sign the informed consent form

aged ≥ 18 years and ≤ 60 years, female

ECOG 0-2

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；

Disqualifiers

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).

Pregnancy or lactation.

any other condition that the investigators think the patient is unsuitable for participation in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • hyperbaric oxygen therapy and povidone-iodine wet compresses

    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.

  • wet compresses of povidone-iodine

    Other intervention

    wet compresses of povidone-iodine

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: hyperbaric oxygen groupExperimental treatment 1 intervention
Group B: Normal groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Number of times for hyperbaric oxygen treatment

Time frame
at the end of the study (at 3 month)
3

Interval between surgery and hyperbaric oxygen treatment

Time frame
baseline
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: