Flap NecrosisNCT06811857
This Study Aims to Explore the Efficacy of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
A study testing hyperbaric oxygen therapy and povidone-iodine wet compresses and wet compresses of povidone-iodine in people with Flap Necrosis and Flap Ischemia, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Flap Necrosis, Flap Ischemia
- What is being tested?
- hyperbaric oxygen therapy and povidone-iodine wet compresses and wet compresses of povidone-iodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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；
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kun Wang contact
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Kun Wang, Phd, 13922118086, gzwangkun@126.com
About this study
Official title: An Exploration 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.
Read the 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.
- Conditions
- Flap Necrosis, Flap Ischemia
- Being tested
- hyperbaric oxygen therapy and povidone-iodine wet compresses, wet compresses of povidone-iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapy and povidone-iodine wet compressesDevice
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-iodineOther
wet compresses of povidone-iodine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: hyperbaric oxygen therapy and povidone-iodine wet compresses |
| Normal group | Active comparator | The control group is given wet compresses of povidone-iodine. Receives: Other: wet compresses of povidone-iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SKIN Area Score of Clavien-Dindo classification
Measured: 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
Measured: 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
Measured: at the end of the study (at 3 month)
Interval between surgery and hyperbaric oxygen treatment
Measured: baseline
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.
Measured: 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
Measured: During hyperbaric oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start31 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flap NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
- Investigators
- Kun Wang Kun Wang, PhD, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811857
- Sponsor's protocol ID
- KY2024-1048-03
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06811857
- Acronym / sponsor ID
- KY2024-1048-03
- Conditions
- Flap Necrosis, Flap Ischemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen group | Experimental | Device: hyperbaric oxygen therapy and povidone-iodine wet compressesThe 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. |
| Normal group | Active comparator | Other: wet compresses of povidone-iodineThe control group is given wet compresses of povidone-iodine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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；
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapy and povidone-iodine wet compressesThe 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. | Device | hyperbaric oxygen group |
| wet compresses of povidone-iodinewet compresses of povidone-iodine | Other | Normal group |
Primary outcome
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
5 secondary outcomes
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
Number of times for hyperbaric oxygen treatment
Time frame: at the end of the study (at 3 month)
Interval between surgery and hyperbaric oxygen treatment
Time frame: baseline
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
side effects of hyperbaric oxygen treatment
Time frame: During hyperbaric oxygen therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes
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B4P Trial - BLOOM43 for Preconditioning
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kun Wang contact
Kun Wang Kun Wang, PhD study chair
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy and povidone-iodine wet compresses and wet compresses of povidone-iodine in people with Flap Necrosis and Flap Ischemia, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun wang, PhD (86+15989223200, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.