GANIK Derma - Product File EN -mod -2015.10.27 bleed FINAL · base of natural ingredients (Oliven...

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HydroACTIVE therapy back to natural care PRODUCT FILE GAN KDERMA www.ganikderma.com GANIK DERMA GANIK DERMA

Transcript of GANIK Derma - Product File EN -mod -2015.10.27 bleed FINAL · base of natural ingredients (Oliven...

Page 1: GANIK Derma - Product File EN -mod -2015.10.27 bleed FINAL · base of natural ingredients (Oliven oleum, Helianthus oleum, Cera, Camphora, Gum Rosin, Ricini oleum hydrogenate, Bismuthi

HydroACTIVE therapyback to natural careback to natural care

PRODUCT FILE

GAN KDERMA

www.ganikderma.com

GANIKDERMAGANIKDERMA

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1. DESCRIPTION AND GENERAL CHARACTERISTICS®1.1 Description of GANIKDERMA product range

®1.2 Therapeutic properties of GANIKDERMA ointment1.3 Presentation1.4 Composition1.5 Fabrication1.6 Storage life and conditions

2. PHYSICAL CHARACTERISTICS®2.1 GANIKDERMA ointment

3. ACTION MODE3.1 Anti-inflammatory and Antibacterial actions3.2 Granulation3.3 Cicatrization3.4 The action of debridement3.5 Nonadherence

4. TOLERANCE AND TOXICITY

5. CLINICAL CHARACTERISTICS5.1 Indications5.2 Instructions for use5.3 Precautions

6. CLINICAL INVESTIGATIONS6.1 Objectives6.2 Methods6.3 Conducting clinical investigations6.4 Description of selected objects6.5 Statistical analysis6.6 Results6.7 Data analysis6.8 Conclusions

7. CLINICAL CASES

8. CONCLUDING REMARKS

9. ECONOMICAL ASPECTS

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1. DESCRIPTION AND GENERAL CHARACTERISTICS

®1.1. Description of GANIKDERMA product range

1.2. Therapeutic properties of ® GANIKDERMA ointment

GANIKDERMAGANIKDERMA

® GANIKDERMA is a hydro active product range (moist environment) which offers solutions in all phases of wounds healing process and of dermatological affections.

®Effectiveness of GANIKDERMA products has been clinically proven over a Multicentre Clinical Investigation conducted in several departments of Plastic and Reconstructive Surgery in Romanian Hospitals (according to EN ISO 14155:2011). Products were evaluated in all phases of wound healing, in combination with adjuvant hypertonic solutions or Ringer solution, in cases of acute, chronic wounds or infected wounds. The study included wounds of various etiologies – superficial and deep burns, pressure sores, leg ulcers and diabetic foot ulcers.

® However, GANIKDERMA products were evaluated in Plastic Surgery Departments, General Surgery Departments, Maxillofacial Surgery Departments, Orthopedics Surgery Departments, Dermatology Departments, and so on, in several hospitals in Romania, including:

· Emergency Hospital “Prof. Dr. Bagdasar-Arseni” – Bucharest

·��Floreasca Emergency Hospital – Bucharest·� Clinical Hospital No.1 – Timisoara·� Municipal Hospital – Timisoara·� Emergency County Hospital – Constanta·� Emergency County Hospital – Craiova

Due to the hydroactive element and Ointment base of natural ingredients (Oliven oleum, Helianthus oleum, Cera, Camphora, Gum Rosin, Ricini oleum hydrogenate, Bismuthi subga l las ) , i n te rna t iona l pa ten ted ,

®GANIKDERMA products provide modern, complete solutions, speed wound healing phases, provide good patient compliance and reduce total cost of treatment.

1.2.1. It stimulates the development of granulation tissue and favors healing by:

· Ensuring a favorable microclimate for healing by stimulating epithelial cells, keratocytes and endothelial cells by restoring the skin's lipid barrier and stimulating the production of collagen and elastin

· Increasing epithelization even in the case of deep wounds by stimulating the reserves of residual epithelial cells

· Accelerate the wound bed vascularization· The anti-inflammatory effect and the

absorption of exudate excess allow an optimal debridement

1.2.2. Prevent wound infection, especially those located in risk areas:· Antibacterial action of phenolic acids,

flavonoids, ferulic acid and ricinoleic acid, ®components of GANIKDERMA ointment

· Antiseptic action of colophonium and camphor

1.2.3. Special comfort for the patient reducing pain, thus allowing early mobilization

1.2.4. It favors the development of a good quality epithelium

1.2.5. It is not adherent (to tissues) to the wound; removal is easy and atraumatic

1.2.6. Easy to apply in the case of wounds found in difficult areas (e.g. anatomical folds, mucocutaneous junctions, etc.)

1.3.Presentation

®GANIKDERMA products range comprises:

Packed in individual envelope, applicator and tubes with different quantities of ointment, which makes

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possible an optimal treatment of wounds and skin diseases, regardless of location

®GANIKDERMA

2. PHYSICAL CHARACTERISTICS

®2.1. GANIKDERMA ointment

®GANIKDERMA ointment is improving the healing process by ensuring a moist environment favorable healing, characterized by constant wound hydration, temperature and pH.

2.1.1. Wound hydrationProviding a moist environment is a key factor of wound healing. Reaction of cellular metabolism is effective only in a moisten vironment.

2.1.2. Temperature In vitro, keratocytes optimal growth temperature is 37ºC

GANIKDERMAGANIKDERMA

1.4.Composition®GANIKDERMA ointment contains natural

plant extracts and electuary: Cera, Gum ros in , Ca lendu la , R i c i n i o l eum hidrogenate, Oliven oleum, Camphora, Boswellia, Bismuthi subgallas, Helianthus oleum, international patented and international trademark.

1.5.Fabrication®G A N I K D E R M A p r o d u c t r a n g e i s

manufactured by GANIKDERMA S.R.L.which is certified ISO 13485.

The products are certified ®GANIKDERMA

medical devices class IIb, CE 0546

1.6.Storage, life and conditionsValidity: 3 yearsStorage conditions:·�Impregnated compress: horizontal, kept

away from humidity at temperature under 25ºC

·�Applicator and tube: vertical, kept away

Dressing made with impregnated dressings or/and ointment are thermally ®GANIKDERMA

insulated. For example leg ulcers temperature increases from 32.7ºC, to about 36ºC after covering with a dressing. This ®GANIKDERMA

phenomenon is favorable for the healing, providing increased cellular metabolic activity (accelerations of enzymatic reactions)

2.1.3. pH®GANIKDERMA products have a neutral pH

(pH = 6.5 – 7.5)

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Besides the properties listed in this section, in ®granulation phase, GANIKDERMA :

Fig. 2 – pressure sore. A – initial; B – granulation tissue after one month of treatment of with

® GANIKDERMA product

Fig. 3 – pressure sore. A – initial; B – wound cicatrization after one month of treatment with

® GANIKDERMA product

GANIKDERMAGANIKDERMA

3.1. Anti-inflammatory and Antibacterial actions

Anti-inflammatory and antibacterial properties of Ointment are due to natural ®GANIKDERMA

ingredients Phenols, Oleocanthal, Fatty acids, Phenolic and Ferulic acids, etc., that also help reinstallation of the lipid barrier of the skin. Also, Bismuthi subgal las has ant i -inflammatory properties and works as hemostatic and antimicrobial agent.

3.2. Granulation

Apart from a functioning microcirculation, a balanced moist wound environment is another important requirement for the formation of granulation tissue. The progress of healing is equally disturbed by drying of the wound or/and by excessive secretion.

· Provides natural micronutrients required for protein synthesis: fatty acids, sterols, esters, glyceride, provitamin A, Vitamin, C, vitamin E. They are necessary for the proper function of producing collagen, the primary constituent of the granulation tissue that heals a wound and the key component in blood vessel walls.

· Provides the early development of granulation tissue by stimulating epithelial cells, keratocytes and endothelial cells by restoring the skin's lipid barrier and the production of collagen and elastin.

3.3. Cicatrization

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3.5. Nonadherence

Compress contains an optimal quantity of

ointment. It doesn't adhere to the wound and

can be removed without pain and trauma.

®GANIKDERMA

Regarding the sensitivity, this is induced by the ointment ingredients, which most of them are natural extracts of plants; some of them could be allergens.

Induced by the allergens of the ointment, the sensitizing characteristic of the product has no consequences for the wound healing process.

®GANIKDERMA Ointment provides the proper environment and moreover expedites the process by offering the following solutions:· Ensures a moist environment·�Stimulates the regeneration of the cells,

promote the formation of the collagen and elastin due to the esters content and palmitic acid

·�Promote the formation of the tissues due to the Vitamin E, Oleic acid, and Phenolic compound (anthocyanin, flavonoid, tannins, phenolic acids)

®GANIKD E R M A Ointmen t p revents hypertrophic scar formation by accelerating and controlling the quality of previous phases of the healing process and maintaining a normal, balanced ratio of fibroblasts to epithelial cellsIn the epithelialization phase the conditions for mitosis and migration of epithelial cells are improved under moist dressing made with

®GANIKDERMA Ointment. This generally leads to rapid epithelial ization with cosmetically more favorable results.

3.4. The action of debridement

Optimum viscosity of the ointment. Meanwhile, ®GANIKDERMA ointment contains moisturizing

and absorbing elements with properties that provide autolytic debridement.

® GANIKDERMA ointment is non cytotoxic which means that not impair local cell function and not have negative effect on the wound tissue.

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5.1. Indications first, second a and b, third degree burnsAs the product presents a good skin tolerance, it is indicated in the:· Local treatment of acute wounds: first,

second a and b, third degree burns, excoriations, ulcerations, other traumatic wounds and other skin injuries;

· Local treatment of pathologic scars (hypertrophic scars or keloids);

· Local treatment of bed-sores, chronic vascular ulcers;

· Local treatment of wet eczemas, contact dermatitis, psoriasis, radio dermatitis;

· Local treatment after chemical or laser peeling

· Local treatment of the donor area or cutaneous transplant graft.

5.2. Instructions for use

Instructions for use for the impregnated compress:· The wound must be cleaned with hypertonic

solutions (physiological serum, Ringer Solution), before each use of the impregnated compress

· The impregnated compress is applied in a single layer directly on the wound, after removal of protective films. The compress can be cut using a sterile instrument to match the dimensions of the wound. A sterile bandage (gauze or nonwoven dressing) is applied on the compress in order to protect the favorable environment of healing produced by the ointment. The compress is replaced every day or every two days, depending on the wound and doctor's indication

· In case of larger surfaces of the wound, more compresses must have 6-8 mm overlay.

Instructions for use of ointment applicator/ointment tube:· The wound must be cleaned with hypertonic

solutions (physiological serum or Ringer solution), before each use of the ointment;

· The ointment is applied on the whole wound in a 1-2 mm layer. A sterile dressing (gauze or nonwoven dressing) is applied on the ointment in order to protect the favorable environment of healing produced by the ointment. The dressing is replaced every day or every two days, depending on the wound and doctor's indication.

In case of dermatological diseases:· The ointment is applied 6-7 times per day,

in case of contact dermatitis located on the hands and twice daily in case of dermatitislocated in other areas or psoriasis. The affected area must be first washed with water and neutral soap.

5.3. Precautions

Side effects:· Immediately after application, a local burning

or discomfort sensation and sometimes perilesional hyperthermia may appear; these phenomena spontaneously disappear within 30 to 40 minutes

· During the healing process, a light itching can appear. In this case, scratching the surface has to be avoided in order not to damage the newly formed skin. Eventually medical advice has to be sought

· Local allergic reaction to one of the components of the ointment is possible

· In case of side effects, ask your doctor or pharmacist

Precautions for use:· The impregnated compress/ointment

applicator/ointment tube are not to be used on people who are allergic to any of the ingredients

· If there are signs of local infection, treatment should be continued only with the physician approval

· Storage conditions: at a temperature less than 25ºC, in dry place, away from direct sunlight

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®The evaluation of efficacy of GANIKDERMA products in treatment of burns, pressure sores, leg ulcers and diabetic foot ulcers and its tolerance and acceptability.

Clinical Investigation teams coordinators:-Prof. Ion Bordeianu, M.D., Ph.D., Chief of Plast ic and Reconstruct ive Surgery department – Emergency County Hospital Constanta, 145, Tomis Blvd, Constanta, Romania- Horia Parvanescu, M.D., Ph.D., Chief of Plast ic and Reconstruct ive Surgery Department – Emergency County Hospital Craiova, 1 Tabacu Street, Craiova, RomaniaClinical Investigation performed according with EN ISO 14155

6.1. Objectives

Main Objective

The evaluat ion of effect iveness of ®GANIKDERMA products in treatment of burns,

pressure sores, leg ulcers and diabetic foot ulcers. The efficacy was appraised by:

· The clinical evolution of wounds (surclinical investigation teams), during four weeks treatment (or until the wound healing) in burns cases and during ten weeks of treatment (or until the wound heling) in pressure sores, leg ulcers and diabetic foot ulcers cases

· The clinical evolution of wounds volumes (clinical exam made by the members of clinical investigation team, determining the maximum depth of the wound), under the same conditions as above

· The clinical evolution of wound tissue types from chronic wounds (clinical exam made by the members of the clinical investigation teams, using colorimetric assessment of chronic wound), under the same conditions as above

· Estimation of wounds superinfection

Secondary ObjectiveThe evaluation of local tolerance and the

®evaluation of acceptability of GANIKDERMA products, regarding the patients and medical personnel, by the appreciation of the following parameters:

· The medium application time of the dressing ®made with GANIKDERMA Impregnated

®Compress and/or GANIKDERMA Ointment· The lightness of dressing made with

®GANIKDERMA Impregnated Compress ®and/or GANIKDERMA Ointment application

and removal from the wound· The evaluation of pain intensity felt by the

®patient at dressing made with GANIKDERMA I m p r e g n a t e d C o m p r e s s a n d / o r

®GANIKDERMA Ointment removal from the wound

· The announce of eventually side effects

6.2. Methods

Multicenter Clinical Investigation, non-comparative, performed with written consent of the patient, conducted from January to September 2012.

®The direction for use of GANIKDERMA products is similar to other impregnated compresses or ointments for wounds treatment. For wounds cleaning it was used exclusively, physiological serum of Ringer solution.

6.3. Conducting Clinical Investigation

49 subjects were recruited for Clinical Investigation, taking place in two centers, respectively, Plastic and Reconstructive Surgery Departments of Emergency County Hospital Constanta and Emergency County Hospital Craiova,

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A precise description of the wound was done, including the following parameters:- wound type (burn, pressure sore, leg ulcer or

diabetic foot ulcer)- age of wound (hours or days, depending on

the case)- etiology- the initial surface (cm²)- the initial maximum depth (cm)- proportion of tissue types (necrosis, fibrin,

granulation tissue and epithelization tissue)- localization; other relevant characteristics The subjects were supervised by the members of clinical investigation teams, by monitoring parameters described at point 6.1

6.2. Description of selected subjects

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6.5 Statistical analysis

THE MAIN OBJECTIVES

6.5.1. The evolution of wounds surfaceThe determination of wound surface was made when the subject was recruited in clinical investigation. After each removal of the

®dress ing made w i th GANIK D E R M A ®Impregnated Compress or/and GANIKDERMA

Ointment, the photographical method was used for assessment. The data regarding the evolution of the wound surface, for each subject, was centralized into a chart, depending on the control number. In order to determinate the evolution of wound surface depending on time (day of treatment), the wound surface observed in the treatment day (days) when it hasn't been removed the dressing, it was calculated as average of the wound surfaces observed in the treatment days, when the dressings were changed (when the surface was measured); the data obtained in this way was centralized into separated charts.Afterwards, the evolution of the wounds surfaces (for each type of wound) was calculated, for all subjects, for each of the treatment days. The initial surfaces of the wounds were considered 100%, following surfaces were calculated as a percentage of the initial surface. Graphs which contain wound surface evolution were drawn for each type of wound, for all subjects selected into the clinical investigation.

6.5.2. The evolution of wound volumeWound volume was determined from the maximum depth of the wound, using Kundin formula: V= 0.327 x S x p, where:S = wound surfacep = maximum depth of the wound0.327 = correction factorSubsequently, calculation was performed under same condition as wound surface

6.5.3. The evolution of wound tissue types from

chronic wounds

Changing patterns of wound tissues was

performed by colorimetric assessment of the state

of pressure sore, leg ulcer and diabetic foot

Ulcer, at the start of clinical investigation

(examination o.”0”) and at each change of dressing ®made with GANIKDERMA products.

Thus, case Report Forms contained a box divided

into four columns, one for each color, in the form

Where:

Black- signifies the presence of necrosis, dry or

moist

Yellow – signifies the presence of fibrin

Red – signifies the presence of granulation tissue

Pink – means epithelization

6.5.4. The evaluation of wound superinfection

The evaluation of wound superinfection was made ®when the dressing made with GANIKDERMA

products were removed. On this occasion, was

evaluated the presence of odor from the wound too.

SECONDARY OBJECTIVES

6.5.5. Average period of the application of ®dressing made with GANIKDERMA products

Was determined as average of the application

periods for each subject and for each type of wound

6.5.6. Ease of application and ease of removal ®of dressing made with GANIKDERMA products

Ease of application on the wound, respectively ®ease of dressing made with GANIKDERMA

products removal from wound, was appreciated by

the investigator.

below:

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6.5.7. Pain intensity felt by the subject at ®the dressing made with GANIKDERMA

products removal

The determination of pain intensity by the subjects at the removal of dressing was made for each dressing removal process from the wound area, using Wong-Baker scale, combination between facial symbols and numeric values. Before evaluation of the pain intensity, the investigator has explained to the subject howto fill in, as well as the meaning of symbols and numbers.

6.5.8. Side effects

The appearance of side effects was monitored by investigator for each subject, during the whole period of wound treatments with

®GANIKDERMA products.

6.6. Results

®6.6.1. Use of GANIKDERMA products

After wound cleaning with physiological serum or Ringer, to each patient has been applied a d ress ing made w i th one o r more

®GANIKDERMA Impregnated Compresses, in a ®single layer, or GANIKDERMA Ointment; these

covered all wound surface. In case of deep wounds, to cover the wound with ointment,

®was used in addition GANIKDERMA Ointment. A f ter app l ica t ion , the impregnated

®compress(es) or/and GANIKDERMA Ointment, was covered with steri le absorbent compresses (gauze or unwoven), to assure the absorption of excess exudate. The dressing made in this way was fixed with gauze bandage.

THE MAIN OBJECTIVES OF CLINICAL INVESTIGATION

6.6.2. Evolution of burns healing

6.6.2.1. The evolution of the burn surfaceEvolution of the burn surface in time (days of

®treatment) during treatment with GANIKDERMA

products, is shown graphically below:

Fig. 4 – Evolution of burn surface in time, during treatment

®with GANIKDERMA products

Depending on the degree of burn, graphs

corresponding to the evolution of burn

surface in time are given below:

Fig. 4.1 – Evolution of IIa degree burns surface during

®treatment with GANIKDERMA products

Fig. 4.2 – Evolution of IIb degree burns surface during

®treatment with GANIKDERMA products

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Fig. 4.3 – Evolution of III degree burns during treatment with

®GANIKDERMA products

6.2.2.2. The evolution of the burn volumeEvolution of burn volume in time (days of t r e a t m e n t ) d u r i n g t r e a t m e n t w i t h

®GANIKDERMA products, is shown graphically below:

Fig. 5 – Evolution of burn volumes during treatment with

® GANIKDERMA products

6 .6 .2 .3 . The evo lu t ion o f burns superinfectionDuring clinical investigation, no infection of b u r n a p p e a r e d , c a u s e d b y u s i n g

®GANIKDERMA products.SECONDARY OBJECTIVES OF CLINICAL INVESTIGATION

6.6.2.4. The average period of the application of dressing made with

®GANIKDERMA productsThe average period of the application on the

®burn of dressing made with GANIKDERMA products was 2,07 days

6.6.2.5. Pain intensity felt by the patient at ®dressing made with GANIKDERMA removal

from burn

Pain intensity felt by the patients at dressing

removal, is given below:

Fig. 6 – Pain intensity felt by the subjects at dressing made with ® GANIKDERMA products removal from burn, depending on

control number

6.6.2.6. Ease of application, respectively, ease ®of dressing made with GANIKDERMA products

removal from burnIn all cases, the application, respectively removing from the burn area of the dressing made with

®GANIKDERMA products, was light.

6.6.2.7. The local side effectsIn case of three subjects, in the first days of

®treatment with GANIKDERMA products, appeared a discrete perilesional pruritus, which was solved without a supplemental treatment.

6.6.3. Evolution of pressure sores healing

THE MAIN OBJECTIVES OF CLINICAL INVESTIGATION6.6.3.1. The evolution of pressure sore surfaceEvolution of pressure sore surface in time (days of

®treatment) during treatment with GANIKDERMA products, is shown graphically below

Fig. 7 – Evolution of pressure sores surface during

® treatment with GANIKDERMA products

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6.6.3.2. The evolution of pressure sores volumeEvolution of pressure sore volume in time (days of treatment) during treatment with

®GANIKDERMA products, is shown graphically below:

Fig. 8 – Evolution of pressure sores volume during treatment

® with GANIKDERMA products

6.6.3.3. The evolution of wound tissue types from pressure soresAll subjects with pressure sores were examined regarding the evolution of wound tissue types (necrosis, fibrin, granulation tissue and epithelization tissue) and found a decrease (to extinction) of necrosis, a decrease (to extinction) of fibrinous tissue and an increase of epithelization tissue, compared to the proportion of granulation tissue. For example, in case of subject No. 1 (C.C), evolution is given below:

6.6.3.4. The evaluation of pressure sore superinfectionDuring clinical investigation, no infection of pressure sore appeared, caused by using

®GANIKDERMA products.

SECONDARY OBJECTIVES OF CLINICAL INVESTIGATION

6.6.3.5. The average period of the application of dressing made with

®GANIKDERMA products. The average period of the application on the pressure sore of

®dressing made with GANIKDERMA products, was 1,41 days.

6.6.3.6. Pain intensity felt by the patient at ®dressing made with GANIKDERMA removal

from pressure sorePain intensity felt by the patient at dressing removal, is given below:

Fig. 9 – Pain intensity felt by the subjects at dressing made with ® GANIKDERMA products removal from pressure sore,

depending on control number

6.6.3.7. Ease of application, respectively, ®ease of dressing made with GANIKDERMA

products removal from pressure soreIn all cases, the application, respectively removing from the pressure sore area of the

®dressing made with GANIKDERMA products, was light.

6.6.3.8. The local side effectsIn case of one subject, in the first days of

®treatment with GANIKDERMA products, appeared a discrete perilesional pruritus, which was solved without a supplemental treatment.

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6.6.4. Evolution of leg ulcers and diabetic foot ulcers healing

THE MAIN OBJECTIVES OF CLINICAL INVESTIGATION

6.6.4.1. The evolution of ulcers surfaceEvolution of ulcers surface in time (days of t r e a t m e n t ) d u r i n g t r e a t m e n t w i t h

®GANIKDERMA products, is shown graphically below:

Fig. 10 – Evolution of ulcers surface during treatment with ®GANIKDERMA products

6.6.4.2. The evolution of ulcers volumeEvolution of ulcers volume in time (days of t r e a t m e n t ) d u r i n g t r e a t m e n t w i t h

®GANIKDERMA products, is shown graphically below:

Fig. 11 – Evolution of ulcers volume during treatment with ® GANIKDERMA products

6.4.4.3. The evolution of wound tissue types from leg ulcers and diabetic foot ulcersAll subjects with pressure sores were examined regarding the evolution of wound tissue types (necrosis, fibrin, granulation

tissue and epithelization tissue) and found a decrease (to extinction) of necrosis, a decrease (to extinction) of fibrinous tissue and an increase of epithelization tissue, compared to the proportion of granulation tissue.For example, in case of subject No. 1 (T.R.), evolution of wound (diabetic foot ulcer) tissue types is given below:

In case of subject No. 2 (X.S.) evolution of wound (leg ulcer) tissue types is given below:

6.6.4.4. The evaluation of leg ulcers and diabetic foot ulcer superinfectionDuring clinical investigation, no infection of leg ulcer or diabetic foot ulcer appeared, caused

®by using GANIKDERMA products.

SECONDARY OBJECTIVES OF CLINICAL INVESTIGATION

6.6.4.5. The average period of the application of dressing made with

®GANIKDERMA productsThe average period of the application on the leg ulcer and diabetic foot ulcer of dressing

®made with GANIKDERMA products, was 1,35 days

6.6.4.6. Pain intensity felt by the patient at ®dressing made with GANIKDERMA removal

from leg ulcers and diabetic foot ulcerPain intensity felt by the patients at dressing removal, is given next:

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Fig. 12 – Pain intensity felt by the subjects at dressing ®made with GANIKDERMA products removal from

wound, depending on control number

6.6.4.7. Ease of application, respectively, ®ease of dressing made with GANIKDERMA

products removal from leg ulcers and diabetic foot ulcerIn all cases, the application, respectively removing from the wound area of the dressing

®made with GANIKDERMA products, was light.

6.6.4.8. The local side effectsIn case of one subject, in the first days of

®treatment with GANIKDERMA products, appeared a discrete perilesional pruritus, which was solved without a supplemental treatment.

6.7. Data analysis

®6.7.1. Burns treated GANIKDERMA products

Burns surface decreased by 50% after 5,12 ®days of treatment with GANIKDERMA

products, their evolution towards healing, was made without notice side effects. Burn healing time ranged between 3 and 26 days depending on the independent variables of treatment such as lesion agent (flame, hot liquid, etc.), subject age, and associated medical affections. The average time to complete healing of burns, was 14,48 days, wounds were covered with newly formed epithelium tissue with high quality.Depending on burn degree, healing occurred as follows:

- Burns IIa degree, were healed in a range between 3 and 11 days, with an average of 7,56 days

- Burns IIb degree, were healed in a range between 10 and 22 days, with an average of 13,07 days

- Burns III degree, were healed in a range between 20 and 26 days, with an average of 22,83 days

In terms of burn volume, after 4,5 days of treatment, it was reduced by 50% and after 10 days of treatment the average volume of burns represented 10% of the original.

During treatment with products, ®GANIKDERMA

no burn was infected and had no smell.

The average intensity of pain felt experienced by subjects at dressing made with

®GANIKDERMA products removal from burn surface, estimated according Wong-Baker scale, was 1,05, which is a pain that can be overlooked.

Dressings made with products ®GANIKDERMA

(Impregnated Compresses or/and Ointment), were changed on average every 2,07 days; ease of application and ease of dressing removal being assessed by doctors as very good. It should be noted thatthe change of dressings made with the ®GANIKDERMA

productswere atraumatic, without trauma to newly formed tissues (granulation and epithelization).

Burns healing during treatment with ®GANIKDERMA products ended with a very

good quality of epithelium, with very good results in terms of aesthetics, without developing hypertrophic scars – particularly important in case of patients with burns located on facial or chest area, especially in case of female patients. This had a very positive impact on quality of life for patients who had burns, they managed to reintegrate into society

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6.7.2. Pressure sores treated with ®GANIKDERMA products

Pressure sores surface decreased by 50% ®after 16 days of treatment with GANIKDERMA

products, their evolution towards healing, was made without noticing side effects. After 38,5 days of treatment, the average of pressure sore surfaces was 25% of the original, and after 81 days of treatment, 83% of them were completely healed, the remaining 17% showed a surface of 0,85%of the original (considered 100%)In terms of pressure sore volume, after 14,5

®days of treatment with GANIKDERMA products, it was reduced by 50% and after 37 days of treatment, the average volume of burns represent 25% of the original.After 69 days of treatment, pressure sores have not presented any depth, all became superficial.

®During treatment with GANIKDERMA products, no pressure sore was infected and had no smell. Colorimetric evaluation of wound tissue types (Black – necrosis, black or brown, wet or dry, Yellow – fibrin, Red – granulation tissue and Pink – epithelization tissue), showed progress towards healing in all cases, from black/yellow to red/pink, which proves the

®effectiveness of GANIKDERMA products intreatment on chronic wounds, because allows an optimal autolytic debridement, without recurrence of necrosis or fibrinous tissue. Thus, on average, after 10 days of treatment, the necrotic tissue was removed entirely, favoring healing of pressure sores.

The average intensity pain felt experienced by ®subjects at dressing made with GANIKDERMA

products removal from pressure sore surface, estimated according Wong-Baker scale, was 0,89, which is a pain that can be overlooked.

®Dressings made with GANIKDERMA products (Impregnated Compresses or/and Ointment) were changed on average every 1,41 days; ease of application and ease of dressing removal were assessed by doctors as very good. It should be noted that the change of the

®dressings made with GANIKDERMA

productswere atraumatic, without trauma to newly formed tissues (granulation and epithelization). Pressure sores healing during treatment with the

®GANIKDERMA products ended with a very good quality of epithelium, stable, with very good results in terms of aesthetics.

6.7.3. Leg ulcers and diabetic foot ulcers treated with products®GANIKDERMA

Leg ulcers and diabetic foot ulcers surface decreased by 50% after 30 days of treatment with products, their evolution ®GANIKDERMA

towards healing, was made without notice side effects. After 57 days of treatment, 30,77% of them were completely healed, the remaining 69,23% showed a surface of 15% of the original (considered 100%).In terms of leg ulcer and diabetic foot ulcers volume, after 6 days of treatment with

®GANIKDERMA products, it was reduced by 50% and after 39 days of treatment, the average volume of wounds represented 10% of the original, which proved great efficiency of

®GANIKDERMA products in treatment of leg ulcers and diabetic foot ulcers.During treatment with products, ®GANIKDERMA

no leg ulcer or diabetic foot ulcer was infected and had no smell. Colorimetric evaluation of wound tissue types (Black – necrosis, black or brown, wet or dry, Yellow – fibrin, Red – granulation tissue and Pink – epithelization tissue), showed progress towards healing in all cases, from black/yellow to red/pink, which proves the effectiveness of ®GANIKDERMA

products in treatment on chronic wounds, because allows an optimal autolytic debridement, without recurrence of necrosis or fibrinous tissue.The average intensity of felt pain experienced by subjects during the removal of the dressings made wi th ®GANIKD E R M A

products,from leg ulcer or diabetic foot ulcer surface, estimated according to the Wong-baker scale, was 2.32, which is a pain that can be ignored.In one single case of a subject treated with

®GANIKDERMA products, by the first check control, was found a perilesional erythema, then absent.

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®Dressings made with GANIKDERMA products (Impregnated Compresses or/and Ointment), were changed on average every 1,35 days; ease of application and ease of dressing removal were assessed by doctors as very good. It should be noted thatthe change of the

®dressings made with GANIKDERMA productswas atraumatic, without trauma to newly formed tissues (granulation and epithelization)

6.8. Conclusions

The above data proves great efficiency of ®GANIKDERMA products in treatment of acute

wounds (burns) and chronic wounds (pressure sores, leg ulcers and diabetic foot ulcers) in terms of shortening the time of healing, a high quality of epithelization, which has a special importance in case of patients with burns localized on face or chest.

®GANIKDERMA products provide a favorable microclimate for wound healing by stimulating epithelial cells, keratocytes and endothelial cells, promote the vascularization of newly tissues and normal healing mechanisms (wet cell proliferation), also preventing necrosis. Effective management of exudate during treatment resulted in removal of excess secretions, combined with ointment, by absorption and by maintaining an optimal fluid balance.It was also noted the superior efficacy of

®GANIKDERMA products in debridement of chronic wounds (pressure sores, leg ulcers, diabetic foot ulcers). Autolytic debridement

®facilitated by GANIKDERMA products is painless and in most cases does not require surgical procedures.

No special precautions are necessary ®regarding use of GANIKDERMA products,

unless the patient is allergic to a component of ointment.

GANIKDERMAGANIKDERMA

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Female patient, aged 64, know with a bimaleolar fracture, operated about 12 months ago. When presenting in clinic, she had on the lateral side of the ankle a dehiscence wound about 8 cm long. A sample has been taken for antibiogram and surgery treatment consisting of removal of osteosynthesis material (represented by 1 plate and 5 screws) and excision of necrotic tissue to healthy limits. Antibiogram result was positive for Pseudomonas Aeruginosa and the patient start a program with cephalosporin medication for 7 days.

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Patient A.J., 72 years old, male, from urban area, with no other medical history, presented for a 3 days old burn, on his left hand, IIb degree, produced by hot liquid. The initial burn's surface was 120cm², after 7 days of treatment – it was reduced by half, and following 13 days of treatment, the burn was fully healed.

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Patient: K.N., 18 months old, male, from urban area, with no other medical history, presented for a 12 hours old burn on chest, II1 degree, produced by hot water. The initial burn's surface was 73,50cm²,

®after 5 dressings made with GANIKDERMA Ointment, one week of treatment, burn was healed completely, with very good epithelization, without pain at dressing removal

Turcanu Luis Children's Hospital Timisoara, RomaniaDoctor: CalinPopoiu, M.D., Chief of Pediatric Surgery and Orthopedics Departments

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A 44 years old woman, with multiple sclerosis (2004), spastic paraplegia, bicerebelar syndrome and urinary tract infection presents with a 60 days old sacral pressure sore, IV degree, 25/35/3 cm, with

®fetid necrosis and sacrum exposure; the local treatment consisted in daily dressing with GANIKDERMA Ointment and compresses for 4 months (February – June 2012) with complete epithelization achieved after 131 days.

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Patient J.I., 54 years old, male, from rural area, with no other medical history, presented for a 28 days old burn, on his right leg, IIb degree, produced by hot liquid. The initial burn's surface was, 120cm², after 6 days of treatment – it was reduced by half, and following 15 days of treatment, the burn was fully healed.

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Patient

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Female patient, age 32. When she came to the clinic, she had rosacea acne..

Female patient, age 83. When she came to the clinic, she has a contusion wound on anteromedial (Tibialisanterios) area..

Male patient, age 47. When he came to the clinic, he had palmar psoriasis

INITIAL

INITIAL

INITIAL

AFTER ONE DAY

AFTER 72 DAYS

AFTER 23 DAYS

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Male patient, age 66, retired with heart failure, hypertension, ischemic heart disease, heart rhythm disorders with recurrent syncope, arterial, venous insufficiency and peripheral facial invasive neoplasia. When he came to the clinic, he had a cutaneous Gambier defect 18/10/2, 5cm (180cm²) of mixed etiology (traumatic, superimposed a venous ulcer) with extensive necrosis (40%). Because of the associated pathology and of the risk of the consecutive anesthesia, it was chosen a conservative treatment, with dressings made with Impregnated Compresses. The dressing was changed daily for a ® GANIKDERMA

month, then after two days. The affected skin area was reduced to the current size of 4/1/10, 1cm; the patient was still under treatment.

INITIAL AFTER 34 DAYS

AFTER 293 DAYSAFTER 207 DAYS

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®GANIKDERMA Ointment is a medical device according to the European Directive 93/42/EEC Requirements. It is manufactured by GANIKDERMA S.R.L. which is certified ISO 13485.

®GANIKDERMA Ointment has CE marking (CE 0546)

®GANIKDERMA Ointment is evaluated in terms of risk in accordance with ISO 14971

®GANIKDERMA Ointment is present in the GMDN Database: GMDN code: 58211

®GANIKDERMA Ointment can offer solutions in all phases of healing process by creating a favorable healing microclimate and by supplying with micro nutrients needed in protein synthesis.

®GANIKDERMA Ointment is a valuable tool in fighting against proven pathogens that can form biofilms responsible for delaying chronic wound healing and poor medical care results.

®GANIKDERMA Ointment is expediting all phases of healing process, so that valuable surgical techniques could be used to complete the local treatment, i.e. exposure, grafting, etc.

®GANIKDERMA Ointment use showed that the healing time and the total cost per patient is reduced up to 30%

The total costs per patients could be reduced to up 30% by decreasing the direct costs and indirect costs as well

- the total time of hospitalization is reducing- the total cost per hospitalization day is reducing- the total costs per patient is reducing (less dressings, no need for other local topics)- the case complexity index is increasing

- the total treatment days is reducing- the total treatment costs is reducing (no need for other local topics)

- the total days of temporary incapacity is reducing- the rehabilitation period is decreasing- the quality of life is increasing

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GANIKDERMAGERMANY, ITALY

Email: [email protected]: www.ganikderma.com

www.facebook.com/ganikderma

WOUNDS THAT DO NOT HEAL?INJURIES, BURNS, WOUNDS…?

GAN KDERMA

www.ganikderma.com

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