A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.

Mechanical Tissue Resuscitation™ (MTR®) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid.

This is a single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy.

The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).

The study will be conducted in subsequent phases, to enroll patients in the following populations:

• Phase 1: patients undergoing elective procedures;
• Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and
• Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils.

Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.

Inclusion criteria

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.

Exclusion criteria

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:

• Exclusion criteria 2-12 from Phase 1