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Chitosana®

 

Sterile healing hydrogel for wounds and burns

Indications:

Chitosana®sterile  healing  hydrogel  is  intended  to  heal  and  reduce  the  pain of wounds with dermic infringement:

  • Thermal, electric, chemical (hydrochloric acid) burns,
  • Traumatic wounds  (cuts,  bruises  and  lacerations)  provoked  by  a  cutting  object  (Knives, blades, scissors,),
  • Abrasive wounds (fall on shock points, the knees, shins, elbows, etc.),
  • Wounds by frictions (blisters on extremities),
  • Wounds of iatrogenic origin (surgical operations).

 

General description

Chitosana® is a sterilized by steam healing product applied on all the superficial and deep wounds in a topical application mode.

It is a succinate of Chitosan under topical hydrogel shape, Chitosan stemming from mushrooms.

It is a hydrogel easy to use and easy to apply on even large zones, as the gel has a sufficiently low viscosity to be spread easily over extended wound areas and burns. The pH value of the gel, similar to that of the skin, leads to an immediate, effective, complete and long-lasting relief of the pain caused by the trauma.

Chitosana® is supplied in aluminum tubes of:

è  5g -“Use up to 5 days after first opening”

The  tube is  inserted  into  a  carton,  accompanied  with  its  instructions  for  use.

The shelf life is 24 months from the date of sterilization.

 

The medical device Chitosana® Sterile healing hydrogel is suitable for any type of patient: Profane, man or woman, who can hold an object, who is able to read and understand instructions. 

Attention: Chitosana®is not recommended on pregnant women and infants less than 3 years, as well as persons with a known allergy to one of the components.

Chitosana®sterile  healing  hydrogel  is  intended  to  heal  and  reduce  the  pain of wounds with dermic infringement:

  • Thermal, electric, chemical (hydrochloric acid) burns,
  • Traumatic wounds  (cuts,  bruises,…)  provoked  by  a  cutting  object,
  • Abrasive wounds (fall on shock points, the knees, shins, elbows, etc.),
  • Wounds by frictions (blisters on extremities),
  • Wounds of iatrogenic origin (surgical operations).

 

Contra-Indications:

  • High exuding wounds, as the wounds may become too wet and cause maceration to the surrounded skin,
  • Third degree (full thickness) burns.

 

Instructions for use:

– Wash hands before any application,

– Clean the wound or the surface to be coated,

– Apply directly to the wound in a thick layer,

– The first day several applications can be made (then, an application a day until healing complete),

– Hydrogel will be removed by simple washing.

 

Mode of action :

Chitosana®hydrogel has favorable characteristics to promote a rapid dermal regeneration as well as an accelerated  healing;  it  is  effective on the erythema, swelling, and sensitivity as evidenced in the clinical studies according to the EN14155-1 and -2.

Chitosana®hydrogel,  chitosan-based,  forms  a  permeable  film  to  air,  it  promotes  cell  regeneration  by its  GAG-analogue  activity,  while  protecting  tissues  of  microbial  attacks,  thanks  to  the  amino groups,  charged  positively, which  will  join  the negatively  charged  bacterial  cell  walls  and  then accelerate the death of bacteria.

Recognized   bio stimulation   activity   of   chitosan   ensures   with   Chitosana® hydrogel   a   more   rapid reconstitution of fabrics with easing of pain whatever the origin of the lesion.

Thus, Chitosana®improves  the  condition  of  the  skin  barrier  and  decreases  the  values  of  water loss by a correct regulation of water exchange