A single-arm feasibility trial evaluating a protein-based scaffold system with tissue transfer for the reconstruction of skull fractures

Not Applicable

Recruiting

• Conditions: Acquired defect of the calvanium - trauma, malignancy or osteomyelitis; Salvage of failed calvarial reconstruction; Surgery - Surgical techniques; Injuries and Accidents - Fractures; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12620001171909
• Lead Sponsor: Princess Alexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-09
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified