Improving cranial flap fixation with a bioresorbable adhesive

A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes

This study is testing a new glue made from natural materials to see if it can safely hold skull pieces together during brain surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RevBio (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT06095531 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the safety and efficacy of a bioresorbable bone adhesive, Tetranite, for cranial flap fixation during craniotomy procedures. Participants will be monitored for serious adverse effects and the effectiveness of the adhesive will be assessed through CT imaging and patient-reported outcomes at multiple time points. The study aims to gather data that could support larger clinical trials in the future.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 scheduled for a cranial procedure in the supratentorial location with a clean surgical wound.

Not a fit: Patients requiring procedures that penetrate air sinuses or involve specific surgical approaches like translabyrinthine or transsphenoidal may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the safety and effectiveness of cranial flap fixation, potentially leading to better patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies using bioresorbable materials in surgical applications have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
* Subjects can be any gender, but be between (and including) 18 and 75 years of age
* Subject is scheduled for a cranial procedure in the supratentorial location.
* Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation was encountered).
* Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization.
* Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.

Intra-Operative Inclusion Criteria:

* Width of craniotomy kerf line \< 3mm for more than 75% of the bone flap border

Exclusion Criteria:

* Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).
* Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
* Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary).
* Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
* Subject had radiation treatment to the surgical site, or standard fractionated radiation therapy was planned post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)
* Subject has a condition with anticipated survival shorter than six months.
* Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or chemotherapy treatment was planned within two weeks after the index procedure was performed.
* Standard use of peri-operative steroids (i.e., corticosteroids) is permitted. Chronic steroid use (defined as daily use of corticosteroids for ≥ 8 weeks) for the purposes of reducing the side effects of chemotherapy and/or radiation therapy for cancer is not exclusionary unless the patient is deemed by the investigator to be suffering from steroid toxicity (i.e., Cushing's syndrome) manifested by symptoms and signs such as thin skin, striae, easy bruising, muscle atrophy, upper body obesity, severe fatigue, etc. Use of corticosteroids on a chronic basis (as defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy is exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure.
* Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
* Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• Semmes Murphey Clinic — Memphis, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Timothy R Smith, MD, PhD, MPH — Brigham and Women's Hospital
• Study coordinator: Brian Hess

Conditions Craniotomy; cranial flap fixation; bone adhesive; bioresorbable