A single-arm feasibility trial evaluating the medical grade polycaprolactone/tricalcium phosphate (PCL-TCP) scaffold system with corticoperiosteal tissue transfer for the reconstruction of acquired calvarial defects in adults

Princess Alexandra Hospital0 个研究点目标入组 10 人开始时间: 2020年11月9日最近更新: 2022年11月7日

试验速览

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•Acquired intercalary defect of the calvarium
•Patient aged >18 and <55 years
•Patients aged over 55 may still be eligible for trial after assessment by and at the discretion of the investigators with documentation to that effect provided for the trial documents pertaining to such patients.
•Patient willing and able to comply with the study requirements.
•Patient capable of providing valid informed consent.

•Active infection of the calvarium at the time of study inclusion, manifest as a failed trial off antibiotics in chronic infected cases.
•Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
•Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
•Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the primary investigator, compromise their safety or compliance or interfere with interpretation of study results.
•Patient life expectancy < 36 months.
•Patient unable or unwilling to comply with the treatment protocol.

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