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Greenovo:Clinical study of chitosan-derivative-based hemostat

2016-01-05 / Categories:hemostatic, dressing, hemostasis,
  
Recently, there has been a great deal of interest in the development of new hemostatic dressing to achieve hemostasis when conventional methods fail or cannot be used

[1]. In general, hemostatic agents used for the control of hemorrhage must be non-cytotoxic, biocompatible and resorbable (if required). One of the developed hemostatic products is Hemostatic Bandages (Greenovo Medical Technologies, Oregon, USA), which is essentially composed of chitosan and a nonabsorbable backing in a vacuum-sealed pouch

[2]. Chitin and chitosan are abundant biopolymers derived from renewable resources in nature

[3]. They were reported to accelerate a wound healing process

[4-5] and hemostasis

[6-8]. In our previous study, carboxymethylchitosan, a water-soluble chitosan derivative, was found to possess a greater in vitro hemostatic effect than chitosan

[9]. Carboxymethylchitosan was also clinically found to promote the wound healing process in the treatment of partial-thickness wounds

[10]. The preparation of carboxymethylchitosan-based hemostat, a chitosan-derivative-based prototype (CDP), was attempted in our laboratory. Both in vitro and in vivo hemostatic ability of the developed prototype was assessed in comparison with that of a commercial material, SPONGOSTAN[11]. The results showed that both materials could significantly decrease the clotting time of pure whole blood (p < 0.05); their in vitro hemostatic ability appeared comparable. However, in the animal trial, the CDP could stop the bleeding from the transected rat tails more effectively than SPONGOSTAN Standard; the average bleeding time of the wounds treated with the prototype was much shorter and the amount of blood loss was also lower.  The objective of this study is to clinically evaluate the hemostatic efficacy of this chitosanderivative-based hemostatic prototype, in comparison with that of two commercial materials, SPONGOSTAN Standard  and Algisite-M, in the treatment of split-thickness skin-graft donor sites.

MATERIALS AND METHODS

Preparation of Chitosan-Derivative-Based Hemostat

Typically, 6wt% carboxymethylchitosan aqueous solution was poured into moulds of a given dimension and subsequently lyophilised to produce sponge-like pads. The water-soluble pads were then individually immersed in a gently stirred 10% aqueous calcium chloride solution for 30 min. to form water-insoluble pads. Afterwards, the pads were removed and successively washed with distilled water. The resulting pads were then freeze-dried to yield the CDP, which was sterilised by ethylene oxide gas prior to use.SPONGOSTAN Standard  (a resorbable gelatin sponge) and Algisite-M (a calcium-alginate dressing) were obtained from Department of Surgery, Angthong Hospital.

Patients

Seventeen patients (4 females and 13 males), aged 25-71 years, enrolled in this study between June 2008 - December 2009. The principal conditions and diseases to be treated with splitthickness skin grafts were avulsion wounds (13 patients) and necrotising fasciitis (4 patients). Informed consent forms (Document No. AT.0027.202.5/001) were signed by the patients upon their enrollment in the trial, which was approved by the Independent Ethics Committee of Angthong Hospital.