Effects of Early Skull Repair With Titanium Mesh on Cerebral Blood Flow and Neurological Recovery

NCT03222297 | Completed DMC

• 1 other identifier: TaiheH_002
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the feasibility of CT perfusion technique to monitor the changes of blood perfusion in the brain tissue before and after skull repair using titanium mesh. To determine the best timing for skull repair using the three-dimensional titanium mesh; to compare the effects of early (1-3 months after decompression) and late-stage (6-12 months after decompression) skull repair on neurologic rehabilitation.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• blood perfusion in the brain tissue

  To monitor the changes of blood perfusion in the brain tissue based on CT perfusion technology after skull repair with titanium mesh. 50 mL of iopromide was injected at a rate of 5 mL/s into the median cubital vein of the patients, and 3 seconds later, 256-slice spiral CT (Philips) was used for continuous scan for 50 seconds, followed by image processing using a Philips-specific workstation.

  changes from day 3 before surgery to day 10 after surgery

Secondary Outcomes (1)

• Barthel index

  at day 30 after surgery

Study Arms (2)

test group

Patients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression.

Device: early skull repair

control group

Patients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression.

Device: late-stage skull repair

Interventions

early skull repair DEVICE

Patients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression.

Also known as: test group

test group

late-stage skull repair DEVICE

Patients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression.

Also known as: control group

control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eighty-six patients with craniocerebral injury who had undergone decompression with removal of bone flap from January 2013 to January 2016 were recruited and subjected to skull repair using titanium mesh. All the patients were randomized into two groups: test group (n = 40) with early skull repair within 1-3 months after decompression and control group (n = 46) with late-stage skull repair within 6-12 months after decompression.

You may qualify if:

• Patients underwent decompression via removal of bone flap in the unilateral frontal temporal lobe due to craniocerebral injury and developed no postoperative infection.
• Patients agreed to receive skull repair using titanium mesh.
• Patients and their families agreed to receive CT perfusion examination.
• Patients and their families fully understood the study protocol and agreed to participate in the trial, and then singed the informed consent before the trial.

You may not qualify if:

• Hypertension and diabetes out of control, severe heart disease, brain tumors, brain abscess, and cerebral infarction
• Diseases that have interfered with localized perfusion data, such as intracranial aneurysms, arteriovenous malformations
• Combined with depressed skull fractures and skull base fractures
• Hydrocephalus

Sponsors & Collaborators

• Taihe Hospital: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 19, 2017
• Study Start: January 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02