Overview
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.
Description
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.
Eligibility
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:
1\. Exclusion criteria 2-12 from Phase 1
