To evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint will be the proportion of success (intraoperative
watertight closure) in the treatment of persistent intraoperative CSF leakage
following primary suture repair. Intraoperative watertight closure will be
defined as no CSF leakage from the dural repair intraoperatively following the
randomly assigned treatment with EVICEL or control (additional dural sutures),
as assessed during a Valsalva maneuver 20-25 cmH2O for 5-10 seconds).
The safety endpoints include:
- Incidence of CSF leakage within5 days (± 2) post-operatively.
- Incidence of CSF leakage within 30 days (± 3) post-operatively.
- Incidence of adverse events
- Incidence of surgical site infections (SSI) according to National Healthcare
Safety Network (NHSN) criteria within 30 days (± 3) post-operatively.
Secondary outcome
not applicable
Background summary
A common complication of craniectomy or craniotomy is CSF leakage after sutured
dural closure.
In many cases (new) surgical intervention is required to treat this CSF
leakage. By using Evicel as an adjunct to dura sutures in elective cranial
surgery this can provide intraoperative watertight closure and CSF leakage can
be prevented.
Study objective
To evaluate the safety and efficacy of EVICEL for use as an adjunct to dura
sutures in elective cranial surgery to provide intraoperative watertight
closure.
Study design
This is a randomized, multi-center controlled study evaluating the
effectiveness of EVICEL* as an adjunct to sutured dural closure compared to
control to obtain an intraoperative watertight dural closure.
Subjects will be randomized to either EVICEL Fibrin Sealant (Human) or to
standard dural closure techniques using repair sutures only (control) in a 2:1
allocation ratio and will be stratified by surgical procedure, posterior fossa
or supratentorial craniotomy.
Due to the nature of this treatment and indication this is an open-label study.
Subjects will be followed post-operatively through discharge and for 30 days
(±3) post-surgery. The incidence of CSF leaks will be assessed within 5 days (±
2) and 30 days (±3) post-operatively as detected by any of the following:
clinical observation, diagnostic testing or the need for surgical intervention
to treat a CSF leak or pseudomeningocele.
Intervention
see above
Study burden and risks
Possible risks and discomforts that may be expected include any of the standard
risks and discomforts associated with an elective surgical procedure.
In addition, when medicines are made from human blood, certain measures are put
in place in their manufacturing process to prevent infections being passed on
to patients. These include careful selection of blood donors to make sure those
at risk of carrying infections are excluded, and testing of each donation for
signs of virus or infections. The manufacturing process for Evicel includes
steps that can inactivate or remove viruses. Despite these measures, when
medicines prepared from human blood are administered, the possibility of
passing on infection cannot be totally excluded. This also applies to any
unknown or emerging viruses or other types of infections.
MDA Blood Bank, Tel Hashomer hospital
POB 888, Kyriat Ono 55000
IL
MDA Blood Bank, Tel Hashomer hospital
POB 888, Kyriat Ono 55000
IL
Listed location countries
Age
Inclusion criteria
Preoperative
1. Patient undergoing elective craniotomy/craniectomy for pathological processes in the posterior fossa (such as benign or malignant tumors, vascular malformation, and Chiari 1 malformations) or in the supratentorial region and who are demonstrated to have persistent CSF leakage following primary attempt at suture closure of the dural incision. After primary suture closure of the dural incision, CSF leakage will be evaluated during a Valsalva maneuver 20-25 cmH2O for 5-10 seconds.
2. Administration of perioperative antibiotic prophylaxis
3.Age ><= 18 yrs;Intraoperative
1. Surgical wound classification Class I (refer to Appendix II). Penetration of mastoid air cells during partial mastoidectomy is permitted.
2. The cuff of native dura along the craniotomy edge on each side is wide enough based on surgeon's judgment to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
Exclusion criteria
Preoperative:
1. Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.;Intraoperative:
1. Dura injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dura cuff.
2. Use of implants made of synthetic materials coming into direct contact with dura (e.g., PTFE patches, shunts, ventricular and subdural drains).
3. Planned use of dural onlay patches after primary suture closure of the dura.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-016501-41-NL |
| CCMO | NL31260.029.10 |