Efficacy and safety of a novel moldable, resorbable, and degradable sealant of bone surfaces for hemostasis after bone graft harvesting from the iliac crest.

STUDY DESIGN: 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. SUMMARY OF BACKGROUND DATA: 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.

Dry eye syndrome in thyroid-associated ophthalmopathy: lacrimal expression of TSH receptor suggests involvement of TSHR-specific autoantibodies.

PURPOSE: We evaluated the relationship between ocular surface damage, elevated lid aperture/impaired Bell's phenomenon and reduced tear production in thyroid-associated ophthalmopathy (TAO). Suspecting a possible role of autoantibodies specific for TSH receptor (TSHR), we further investigated TSHR expression in the healthy lacrimal gland (LG). METHODS: A total of 48 patients with active TAO and 26 controls were examined for basal tear secretion, Rose Bengal and fluorescein staining, impression cytology (IPC), break-up time (BUT), and blinking (lid width, lid closure, ocular surface, upward excursion). Healthy LGs were investigated immunohistochemically for expression of TSHR. RESULTS: Thyroid-associated ophthalmopathy patients showed significant ocular surface damage (Rose Bengal staining score: TAO: 2.0 [0-5] versus controls: 0 [0-0.4]; IPC score: TAO 3.0 [0-8] versus controls: 0 [0-1], and BUT: TAO: 3.0 seconds [0-9 seconds] versus controls: 19.5 seconds [13-35.4 seconds]), and significantly reduced tear secretion (TAO: 10 mm [3-20 mm] versus controls: 17 mm [10-27 mm]). Ocular surface damage correlated significantly with tear secretion (r = - 0.35) but not significantly with mechanical alterations (impaired upgaze [r = - 0.34] and ocular surface increase [r = 0.32]). We firstly demonstrate that lacrimal acinar cells physiologically express TSHR. CONCLUSIONS: As ocular surface damage in TAO significantly correlates with reduced tear production, LG impairment appears to be a major cause of ocular surface drying. Intriguingly, physiological expression of TSHR by LG suggests that, in thyroid disease, autoantibodies may bind to lacrimal TSHR and, perhaps via aberrant signal transduction, contribute to LG impairment and, hence, dry eye syndrome.