A drainage device (Mechanical Tissue Resuscitation™) for removing excess fluid after skull surgery

You may qualify if

• Phase 1:
• Patient is willing and able to provide written informed consent or has an appointed legally authorized representative (LAR) who can provide consent on the patient's behalf.
• The patient's age is ≥ 22 and ≤ 65 years.
• The patient has a clinical need for a craniotomy, craniectomy, or cranioplasty and for which, as an integral part of their care, a Jackson Pratt (JP) drain or equivalent would be placed at the surgical site.
• The surgical case is classified as 'clean'. Phase 2:
• All Phase 1 criteria
• Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils. Phase 3:
• All Phase 1 criteria
• Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.

You can't join if

• Phase 1:
• Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
• Patient is pregnant or lactating.
• Patient's BMI > 45
• Patient is participating in another clinical investigation.
• Patient's anticipated survival is < 48 hours.
• Patient is incarcerated at time of hospital admission.
• Patient has a coincidental infection.
• Patient has thrombocytopenia (platelet count < 150,000/µL).
• Patient has an International Normalized Ratio (INR) > 1.5.
• Patient is a known active opioid abuser at the time of surgery.
• Patient is a known active alcohol abuser at the time of surgery.
• Active bleeding at the site of surgery prior to placement of the device. Phases 2 and 3: