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

NCT06811857 | Not Yet Recruiting

• 1 other identifier: KY2024-1048-03
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Flap Necrosis; Flap Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• side effects of hyperbaric oxygen treatment

  During hyperbaric oxygen therapy

Study Arms (2)

hyperbaric oxygen group

EXPERIMENTAL

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.

Device: hyperbaric oxygen therapy and povidone-iodine wet compresses

Normal group

ACTIVE COMPARATOR

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

Other: wet compresses of povidone-iodine

Interventions

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.

hyperbaric oxygen group

wet compresses of povidone-iodine OTHER

wet compresses of povidone-iodine

Normal group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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；

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Kun Wang Kun Wang, PhD

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Kun wang, PhD

CONTACT

86+15989223200; gzwangkun@126.com

Kun Wang

CONTACT

gzwangkun@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 6, 2025
• Study Start: January 31, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)