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NCT Number: NCT06811857

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

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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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location contact

Kun Wang, Phd

CONTACT

[email protected]

13922118086

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

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

wet compresses of povidone-iodine

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

    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

    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.

  5. side effects of hyperbaric oxygen treatment

    Time frame: During hyperbaric oxygen therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Wang

CONTACT

[email protected]

Kun wang, PhD

CONTACT

[email protected]

86+15989223200

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

An Exploration of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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