💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) enhances fat graft survival in lipofilling procedures in irradiated breast cancer patients. The main questions it aims to answer are:
Does it improve fat graft survival ? Evaluate safety and tolerability of HBOT in this setting? Researchers will compare patient receiving HBOT to a control group without HBOT to see if.
Sixteen female patients will undergo two autologous fat grafting sessions: one with HBOT and one without, in a randomized sequence. Patients will undergo three MRI during the study to evaluate the fat retention rate.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Adult (18 y.o. or more) female patients considered for lipofilling following breast reconstruction in an oncological setting which received radiation therapy on the affected breast.
* Ability to provide informed consent, documented by signature
Exclusion Criteria:
* Pregnancy or breastfeeding
* Unability to provide informed consent
* Previous enrolment into the current investigation
Contra-indication to HBOT :
* Anamnestically reported spontaneous pneumothorax
* Status post-thoracotomy
* Significant intra-pulmonary lesions (including emphysematous bullae)
* Respiratory function disorders (both obstructive and restrictive syndromes)
* Pregnancy
* Major psychiatric disorders
* Uncontrollable claustrophobic reaction
* Seizures, even if treated and asymptomatic for some time
* Status post-severe traumatic brain injury with neurological deficits and seizures
* Decompensated heart failure
* Recent myocardial infarction (\<6 months) or with persistent hemodynamic sequelae
* Spastic coronary angina
* Cardiac arrhythmias, atrioventricular block, Wolff-Parkinson-White syndrome, sinus node dysfunction, Lown-Ganong-Levine syndrome
* Cardiac pacemakers with unknown pressure resistance
* Severe bradycardia
* Sinus ostium displacement (acute or chronic)
* Displacement of the auditory canal entrance (acute or chronic)
* Status post-tympanoplasty type I-III \<3 months
* Acute febrile state
* Optic neuritis
* Unstabilized hyperthyroidism
Contra-indication to MRI :
* Non-MRI-compatible pacemaker, cochlear implant, drug-infusion pump or neurostimulator.
* Metallic foreign body in critical area (eye, brain, etc.)
* Ferromagnetic vascular surgical clips of older generation, e.g., for intracranial aneurysm repair.
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