A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated FS VH S/D 500 S-apr (Tisseel) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery.

Baxter Healthcare Corporation25 sites in 4 countries224 target enrollmentOctober 11, 2016

ConditionsCerebrospinal Fluid Leak

InterventionsFS VH S/D 500 s-apr DuraSeal Dural Sealant

DrugsFS VH S/D 500 s-apr

Overview

Phase: Phase 3
Intervention: FS VH S/D 500 s-apr
Conditions: Cerebrospinal Fluid Leak
Sponsor: Baxter Healthcare Corporation
Enrollment: 224
Locations: 25
Primary Endpoint: Number of Participants With No CSF Leak During and After Surgery
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.

Registry

clinicaltrials.gov

Start Date

October 11, 2016

End Date

August 22, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region
•Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed
•Patients must be willing to receive peri-operative antibiotic prophylaxis
•Female patients of childbearing potential must present with a negative serum pregnancy test, and must agree to employ adequate birth control measures \[restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products\] for the duration of their participation in the study
•Patients are willing and able to comply with the requirements of the protocol

Exclusion Criteria

•Patients with a dural lesion from a recent surgery that still has the potential for CSF leakage
•Patients who had undergone chemotherapy treatment, excluding hormonal therapy, within 3 weeks prior to the planned procedure, or with chemotherapy scheduled within 7 days following surgery
•Patients with radiation therapy to the surgical site or standard fractionated radiation therapy scheduled within 7 days following surgery
•Patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery
•Use of corticosteroids on a chronic basis (defined as daily use of corticosteroids for ≥8 weeks) for purposes other than decreasing the symptoms of systemic chemotherapy (unless if those steroids were discontinued 4 weeks prior to the planned surgery)
•Patients with a known hypersensitivity to the components of the IP or control (human fibrinogen, synthetic aprotinin, human albumin, human FXIII, tri sodium citrate, histidine, niacinamide, polysorbate 80, human thrombin, polyethylene glycol \[PEG\], trilysine amine)
•Patients with a known hypersensitivity to US Federal Drug \& Cosmetic Blue #1 dye
•Evidence of an infection indicated by any one of the following: clinical examination supporting the diagnosis of infection, fever (temperature \>100.7°F or 38.2°C), positive urine culture, positive blood culture, positive chest X ray consistent with pulmonary infection, or infection along the planned surgical path. A white blood cell (WBC) count of \<20000 cells/µL is permitted if the patient is being treated with steroids in the absence of all other infection parameters
•Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
•Female patients who are nursing

Arms & Interventions

FS VH S/D 500 s-apr

FS VH S/D 500 s-apr (Tisseel), single use treatment, intraoperative

Intervention: FS VH S/D 500 s-apr

DuraSeal Dural Sealant

DuraSeal Dural Sealant, single use treatment, intraoperative

Intervention: DuraSeal Dural Sealant

Outcomes

Primary Outcomes

Number of Participants With No CSF Leak During and After Surgery

Time Frame: Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative

Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up to 5 - 10 seconds to transiently elevate the intracranial pressure and test for any CSF leaks. The suture line was to be watertight after up to two product/control applications and Valsalva maneuvers.

Secondary Outcomes

Number of Participants With no Intra-operative CSF Leaks Following Final Valsalva Maneuver(Day 0 (Intra-operative))
Number of Participants With CSF Leaks Within 30 (+3) Days Post-operatively(Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative)
Time From Dural Closure (Application of IP) Until End of Surgery(Day 0 (Intra-operatively))
Duration in Surgery (Minutes)(Day 0 (intra-operatively))
Length of Stay in Hospital (Days).(Day 0 to Day 60 (Study Completion))