Clinical trial · Interventional
This Study Aims to Explore the Efficacy of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
An Exploration of Hyperbaric Oxygen in the Treatment of Flap Ischaemic Necrosis After Breast Cancer Surgery
NCT06811857CI-TRIAL-00085563not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The expectation of our study was to explore the efficacy of using hyperbaric oxygen to rescue flap ischaemic necrosis after breast cancer surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Flap Ischemia | — | UNRESOLVED | — |
| Flap Necrosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperbaric oxygen therapy and povidone-iodine wet compresses | Device | — | UNRESOLVED |
| wet compresses of povidone-iodine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hyperbaric oxygen group
- description
- 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.
- interventionNames
- Device: hyperbaric oxygen therapy and povidone-iodine wet compresses
- type
- ACTIVE_COMPARATOR
- label
- Normal group
- description
- The control group is given wet compresses of povidone-iodine.
- interventionNames
- Other: wet compresses of povidone-iodine
Primary outcomes (1)
- measure
- The SKIN Area Score of Clavien-Dindo classification
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.