Efficacy and safety of a novel moldable, resorbable, and degradable sealant of bone surfaces for hemostasis after bone graft harvesting from the iliac crest.
METHODS
A prospective, controlled, open, randomized multicenter study.


OBJECTIVE
The study's objective was to demonstrate equivalence of a novel, moldable, resorbable, and degradable synthetic polymer (Bone Seal) compared with a collagen fleece (Lyostypt) in efficacy and safety for topical hemostasis after iliac crest bone graft harvesting.


BACKGROUND
Harvesting cortico-cancellous bone from the iliac crest is a well established procedure in orthopedic and particularly in spine surgery. It is associated with significant morbidity at the donor site where hematoma formation may cause impaired wound healing and infections in up to 10% of cases.


METHODS
A total of 112 patients were included in the safety analysis. Safety was determined by a compound wound healing score and the incidence of adverse clinical effects. One hundred and eight patients were studied for equivalence in efficacy using a compound bleeding score. The handling properties and the application to the bone surface of either device were measured with two additional compound scores.


RESULTS
The mean bleeding scores in the final analysis was 4.5 +/- 1.3 for the Bone Seal group and 4.2 +/- 1.3 for the collagen fleece group. Bone Seal was better applicable to the bleeding bone surfaces than the collagen fleece, even though its handling was more complicated. Wound healing and the incidences of adverse clinical events were comparable in either study group.


CONCLUSIONS
Bone Seal is an effective and safe hemostatic material for sealing bleeding bone surfaces after iliac crest bone graft harvesting. By virtue of its hemostatic efficacy, Bone Seal is preventive for wound healing disorders.
Pingsmann
Andreas
A
Department of Orthopaedics, Essen University Medical School, Darmstadt, Germany. a.pingsmann@biberburg.de
Blatt
Ruth
R
Breusch
Steffen
S
Jürgens
Christian
C
Thietje
Roland
R
Krödel
Andreas
A
Zinser
Wolfgang
W
Michiels
Ivo
I
Niethard
Fritz U
FU
Niedhart
Christopher
C
Renzing-Köhler
Katrin
K
Pfefferle
Hans-Joachim
HJ
D000328:Adult; D001673:Biodegradation, Environmental; D003094:Collagen / Q000627:therapeutic use; D005260:Female; D006406:Hematoma / Q000139:chemically induced; D006490:Hemostatics / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007085:Ilium / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011108:Polymers / Q000009:adverse effects* / Q000627:therapeutic use*; D020858:Tissue and Organ Harvesting / Q000009:adverse effects; D019737:Transplants; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
D006490:Hemostatics; D011108:Polymers; C508897:bone seal; D003094:Collagen