Skull fractures Plastic Surgery Procedures Skull Fractures
Conditions
Interventions
The study compares two surgical approaches for the reconstruction of cranial bone defects (cranioplasty) using polymethylmethacrylate (PMMA) bone cement. Participants will be randomly allocated into o
s cranial defect to restore the anatomical contour. Group 2 (Intervention - Prototyped molding): Patients will undergo computer-assisted customized cranioplasty. Preoperative computed tomography (CT)
s skull. This is a two-arm, double-blind, randomized controlled clinical trial. Group 1: 10 participants. Group 2: 10 participants
Sponsors
Faculdade de Medicina de Botucatu/UNESP
Faculdade de Medicina de Botucatu/UNESP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: adult patients, both gender, above 18 years old, with cranial bone defects; cranial defect size between 50 cm² and 150 cm²; adequate clinical condition for elective surgery
Exclusion criteria
Exclusion criteria: patients with active infection; history of rejection to biomaterials; patients with immunosuppression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aesthetic Satisfaction: this is the main measure used to compare the two molding techniques (in situ vs. prototyped), it´s expected more satisfaction with prototyped | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical time: evaluation of the total duration of the surgical procedure to verify if prototyping reduces time in the operating room; wound dehiscence: monitoring for any premature opening of the surgical wound; wound infection: assessment of post-operative infectious complications | — |
Countries
BR
Contacts
Public ContactRenato Colenci
Unesp - Universidade Estadual Paulista "Julio de Mesquita Filho"
Outcome results
None listed