Mechanical Tissue Resuscitation for Skull Defects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new therapy called Mechanical Tissue Resuscitation™ (MTR®) to help remove excess fluid from individuals who have undergone partial skull removal, a procedure often necessary for brain healing. The trial aims to determine if MTR® can effectively and safely drain this fluid compared to traditional methods. Participants may qualify if they have had procedures such as craniotomy, craniectomy, or cranioplasty (types of skull surgeries) and require a drain during recovery.
As an unphased trial, this study provides participants the chance to contribute to pioneering research that could enhance recovery methods for future patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Mechanical Tissue Resuscitation™ (MTR®) therapy system is safe for fluid removal in skull defect cases?
Research has shown that Mechanical Tissue Resuscitation™ (MTR®) therapy is safe for humans. Studies have found that controlled suction can safely remove excess fluid from the brain. For instance, one study demonstrated that MTR could remove more than half of the fluid in cases of brain bleeding. Another study discovered that applying MTR immediately after an injury reduced brain swelling and preserved more brain tissue compared to those who did not receive the treatment. These findings suggest that MTR is well-tolerated and does not cause significant side effects.12345
Why are researchers excited about this trial?
Mechanical Tissue Resuscitation™ (MTR®) is unique because it represents a novel approach to treating skull defects, which are typically addressed with surgical interventions like bone grafts or synthetic implants. Unlike these traditional methods, MTR® uses a mechanical process to stimulate the body's natural healing mechanisms, potentially enhancing tissue regeneration without the need for invasive surgery. Researchers are excited about MTR® because it could reduce recovery times and lower the risks associated with surgical procedures, offering a less invasive and more efficient alternative for patients with skull defects.
What evidence suggests that the Mechanical Tissue Resuscitation™ (MTR®) therapy system is effective for skull defects?
Research has shown that Mechanical Tissue Resuscitation™ (MTR®), the treatment under study in this trial, might help treat conditions involving excess fluid in the brain. One study demonstrated that MTR® removed more than half of a brain bleed by applying controlled pressure. Another study found that using MTR® on brain injuries reduced swelling and preserved over 50% more brain tissue compared to untreated cases. These findings suggest that MTR® could help manage fluid-related brain issues and potentially improve outcomes for individuals with skull defects.13456
Are You a Good Fit for This Trial?
This trial is for adults aged 22 to 65 who need part of their skull removed (craniotomy/craniectomy) and would normally have a surgical drain placed. The surgery must be considered 'clean,' and participants must be able to give written consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MTR® therapy for removal of excess fluid from the surgical site
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mechanical Tissue Resuscitation™ (MTR®)
Trial Overview
The study is testing the Mechanical Tissue Resuscitation™ (MTR®) therapy system, a device designed to remove extra fluid after brain surgery in patients with part of their skull temporarily removed.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Renovo Concepts, Inc.
Lead Sponsor
Boston Biomedical Associates
Lead Sponsor
Citations
Novel treatment of intracerebral hemorrhage with ...
This study demonstrates that local continuous application of controlled subatmospheric pressure to an ICH can safely remove more than half ...
2.
researchgate.net
researchgate.net/publication/372226824_Novel_treatment_of_intracerebral_hemorrhage_with_mechanical_tissue_resuscitationNovel treatment of intracerebral hemorrhage with ...
When ICHs were treated with MTR for 2 weeks, the gross hematomas were reduced by 94%, from 112.23 ± 66.21 mm ³ in the nontreated group to 6.12 ± 10.99 mm ³ in ...
3.
newsroom.wakehealth.edu
newsroom.wakehealth.edu/news-releases/2012/04/mechanical-tissue-resuscitation-technology-shows-promiseMechanical Tissue Resuscitation Technology Shows Promise ...
Brains treated with the device showed that over 50% more brain tissue could be preserved compared to nontreated animals. Behavioral function ...
Mechanical tissue resuscitation at the site of traumatic ...
Application of -100 mm Hg for 5 days resulted in significantly improved outcomes. Delays of up to 3 hours between injury and the initiation of treatment did not ...
Cardiopulmonary Resuscitation-Related Head Trauma
Introduction: In all cases of cardiac arrest, adequate cardiopulmonary resuscitation (CPR) performance is crucial for survival.
Mechanical Tissue Resuscitation treatment reduces injured ...
Our previous studies showed Mechanical Tissue Resuscitation. (MTR) treatment right after injury (<1 hour) reduces brain edema and extent of injury, and ...
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