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BIOTIFARM - BIOTITUS ® Derma Impregnated Dressing


    BIOTITUS ® Derma - AN ALTERNATIVE FOR SUPERFICIAL BURNS LOCAL TREATMENT

     There is a wide variety of local therapeutical methods for partial superficial burns. Burns require meticulous local treatment as part of the complex therapeutical protocol. Local treatment for burns is essential, influencing patient’s evolution and future. All local burn treatment methods are adapted in connexion whith burn lesion particularities (age, ethiology, localization, associated pathology). BIOTITUS ® Derma - Imgregnated Dressing was clinically tested for partial superficial burns treatment and results were favorable,healing occuring more rapid, mean hospital stay decreasing as well as treatment costs.
    
     Burns represent the greatest trauma a human being could encounter, the greatest medical and surgical emergency. In Romania aproximately 12000 adults and 5000 children with burns are admitted in hospitals. The number of burns treated outpatients is even greater. In children, burns represents aproximately 40% of total burns. Burns represent important area of public healthcare as well as important area of medical science.

     Burns necessitate specialized local treatment frequently, with important consume

of material and human resources; for patient this therapeutical process is difficult, generating anxiety, pain and stress.

     All treated cases were subjected to the American Burn Association criteria.

     There is a wide area of products for burns treatment. We frequently used clorhexidine, fat tulle, antibiotic ointments with very good results for superficial burns.

     During the last year, we tested a new product (BIOTITUS ® Derma - Impregnated Dressing) for superficial and partial thickness burns.

     BIOTITUS ® Derma - Impregnated Dressing is a hydroactive range which offers the solutions in all phases of the healing process.

     The BIOTITUS ® Derma - Impregnated Dressing range of products has the following properties:

• cicatrizing activity;

• reducing pain;

• debridation action (the absorption of the fluids from the wound allows the autolytic debridement);

• bacteriostatic and bactericide, which allows using in case of non infected wounds and also in case of supra infected wounds, discharging at the same time the malodorous sensations;

• the action of preparing the cell pad for cicatrisation and its stimulation: the antinflamatory effect and the absorption effect of the exudates, together with the moist environment leads to the stimulation of the granulation and cicatrisation tissue;

• doesn’t adhere to the tissue and the removing is without pain or trauma;

• due to the physical characteristics, BIOTITUS ® Derma - Impregnated Dressing range can be use in case of wounds with difficult position.

      The impregnated compresses BIOTITUS ® Derma - Impregnated Dressing is a non occlusive dressing with a complex structure:

• the meshed polyester lattice, which is the support of the compress, allows the drainage of exudates to the absorbent compress which covers the impregnated compress BIOTITUS ® Derma - Impregnated Dressing, avoiding the maceration;

• the meshed polyester lattice allows the migration of granulation tissue;

• because the ointment is applied on the yarn of the meshed polyester lattice, the impregnated compress Immerci BIOTITUS ® Derma - Impregnated Dressing can be removed without pain and trauma.

      The antibacterian action of BIOTITUS ® Derma - Impregnated Dressing range is in conformity with the following properties:


Ointment compound

Constituent

Effect

Olive oil

Phenolics acid

The tannin

Antibacterian action

Antibacterian action

Beeswax

Flavonic derivatives flavonide

Ferule acide

Anti-inflammatory action

Antibacterian and bacteriostatic action

Colophonium


Antiseptic

Camphor


Antiseptic

Castor oil

Ricinoleic acid

Antibacterian action


      Wound cicatrisation is induced by the following constituents of the ointment:


Ointment compound

Constituent

Effect

Olive oil

Glicerids




Fatty acids


Steroids



Esters




Phenolic compounds

(antocian, flavinoid, tannins,

phenolic acids)


Tocoferolis (Vitamin E)


Vitamin A


Intracellular matrix;

The stimulation of the epithelial cells,

keratocytes and endothelial cells


Reinstalation of the lipid barrier of the skin


Biochemical functions on cell membrane

level; improving the collagen content


Simulates the regeneration of the cellules;

promote the formation of the collagen and

elastine


The stimulation of the regeneration of the

tissues



Promote the formation of the tissues


Assure the hydration of the tissues

Sunflower oil

Linolenic acid (Vitamin K)



Oleic acid


Gliceride

Determinates the granulocyte migration and

the macrophage-stimulator in cellules growth


Regenerator of the skin cellules


Intracellular matrix;The stimulation of the

epithelial cells, keratocytes and endothelial

cells

Beeswax

Vitamin A


Esters

Assure the hydration of the tissues


Simulates the regeneration of the cellules;

promote the formation of the collagen and

elastine

Colophonium


Stimulates the blood circulation at the wound level

Castor oil

Linolenic acid


Palmitic acid



Oleic acid

Biosynthesis of the cell membrane


Intracellular matrix; stimulates the synthesis of the colagen and elastine


Regenerating of the skin cellules


     50 patients of pediatric and adult age were recruited for clinical investigation in 2 burn units from Bucharest and Timisoara. A strict description of the burn surfaces,

including the following parameters was made: age of burn (hours), etiology, the initial surface (cm2), localization and oher relevant characteristics.

     The subjects were supervised by the clinical investigation members until the healing of the burn surface.

     The determination of the burn surface was made when the subjects were recruited for clinical investigation, as far as to every removing from the burn area of the impregnated compress BIOTITUS ® Derma.

     Multiple evaluations of the burn surface, including initial evaluation were made.

graf


      On the horizontal axis are the days of the treatment and on the vertical axis are the percentages of burn surfaces.

      After the clinical investigation period, no infection of burn surface appeared, caused by using the impregnated compress BIOTITUS ® Derma. It can be observed that in the sixth day of treatment, the burn surface decreased more than a half of the initial surface, meaning 45,44% from initial surface. In the eleventh day of treatment, the burn surface decrease with 3/4, meaning 25,02% of initial surface.

      Compared to standard treatment for superficial burns, healing occurred earlier with 2.9 days. Treatment cost was ½ compared to standard treatment. Hospital stay decreased with 1.7 days:

      Examples of clinical cases:

a) Female subject, 34 years, thermic burn caused by flame, located on the face, II a degree.


Burn 1.1 Burn 1.2


      Initial aspect and after 5 days of the treatment with the impregnated compress BIOTITUS ® Derma

b) Female subject, 25 years old, thermic burn caused by hot liquid, left hand, dorsal face,I and II a degree.


Burn 2.1 Burn 2.2


      Initial aspect and after 13 days of treatment with impregnated compress BIOTITUS ® Derma

c) Superficial ( IIa degree ) burn of the calf


Burn 3.1 Burn 3.2


      Initial aspect and after 11 days of treatment with impregnated compress BIOTITUS ® Derma.


      The medium period of the application on the burn of impregnated compress BIOTITUS ® Derma was 1,5 days.

      Regarding the acceptability, in all cases, the application, respectively, removing from the burn area of the impregnated compress BIOTITUS ® Derma was lightness made, which prove a good acceptability of the product.

     The medium level of pain intensity felt by the patients when removing from the burn area of the impregnated compresses BIOTITUS ® Derma is less than 1, meaning a pain which is almost insensible on Wong-Baker scale.


      Conclusions:

     The analysis of the clinical investigation demonstrates a good efficacy of the impregnated compress BIOTITUS ® Derma in the burn treatment, as well as a good tolerance and acceptability of this compress.

      The BIOTITUS ® Derma range emerges as a useful local treatment indicated in the local treatment for the superficial burn surfaces.

 
 
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