title: The "Skull Flap" a new conceived device for decompressive craniectomy experimental study on dogs to evaluate the safety and efficacy in reducing intracranial pressure and subsequent impact on brain perfusion.
abstract: BACKGROUND
  Decompressive craniectomy (DC) is a procedure performed increasingly often in current neurosurgical practice. Significant perioperative morbidity may be associated to this procedure because of the large skull defect; also, later closure of the skull defect (cranioplasty) may be associated to post-operative morbidity as much as any other reconstructive operation. The authors present a newly conceived/developed device: The "Skull Flap" (SF). This system, placed at the time of the craniectomy, offers the possibility to provide cranial reconstruction sparing patients a second operation. In other words, DC and cranioplasty essentially take place at the same time and in addition, patients retain their own bone flap. The current study conducted on animal models, represents the logical continuation of a prior recent study, realized on cadaver specimens, to assess the efficacy and safety of this recently developed device.
  
  
  METHODS
  This is an experimental pilot study on dogs to assess both safety and efficacy of the SF device. Two groups of experimental raised intracranial pressure animal models underwent DC; in the first group of dogs, the bone flap was left in raised position above the skull defect using the SF device; on the second group the flap was discarded. All dogs underwent transcranial Doppler (TCD) to assess brain perfusion. Head computed tomography (CT) scan to determine flap position was also obtained in the group in which the SF device was placed.
  
  
  RESULTS
  SF has proved to be a strong fixation device that allows satisfactory brain decompression by keeping the bone flap elevated from the swollen brain; later on, the SF allows cranial reconstruction in a simple way without requiring a second staged operation. In addition, it is relevant to note that brain perfusion was measured and found to be better in the group receiving the SF (while the flap being in a raised as well as in its natural position) comparing to the other group.
  
  
  CONCLUSIONS
  The SF device has proved to be very easy to place, well-adaptable to a different type of flaps and ultimately very effective in maintaining satisfactory brain decompression and later on, making easy bone flap repositioning after brain swelling has subsided.
authors.affiliation: Department of Neurosurgery, Strasbourg University Hospital, Strasbourg, Paris, France ; Department of Neurosurgery, Laribosiere University Hospital, Paris, France.
authors.forename: Chibbaro
authors.initials: C
authors.lastname: Salvatore
authors.affiliation: ICU, Laribosiere University Hospital, Paris, France.
authors.forename: Vallee
authors.initials: V
authors.lastname: Fabrice
authors.affiliation: University Arizona Medical Center, Tucson, Arizona, US.
authors.forename: Marsella
authors.initials: M
authors.lastname: Marco
authors.affiliation: Department of Neurosurgery, Strasbourg University Hospital, Strasbourg, Paris, France.
authors.forename: Tigan
authors.initials: T
authors.lastname: Leonardo
authors.affiliation: Biomedical Research Centre, Veterinary Natrional School, Alfort-House, Paris, France.
authors.forename: Lilin
authors.initials: L
authors.lastname: Thomas
authors.affiliation: Biomedical Research Centre, Veterinary Natrional School, Alfort-House, Paris, France.
authors.forename: Lecuelle
authors.initials: L
authors.lastname: Benoit
authors.affiliation: Department of Neurosurgery, Laribosiere University Hospital, Paris, France.
authors.forename: George
authors.initials: G
authors.lastname: Bernard
authors.affiliation: Department of Neurosurgery, Strasbourg University Hospital, Strasbourg, Paris, France.
authors.forename: Kehrli
authors.initials: K
authors.lastname: Pierre
authors.affiliation: Clinical Research Unit, Lariboisiere - Fernand Widal University Hospital, Paris, France.
authors.forename: Vicaut
authors.initials: V
authors.lastname: Eric
authors.affiliation: Department of Neurosurgery, Strasbourg University Hospital, Strasbourg, Paris, France.
authors.forename: Diemidio
authors.initials: D
authors.lastname: Paolo
keywords: Brain perfusion; cranioplasty; decompressive craniectomy; new device and technique; skull flap; trans-cranial Doppler