Actolind. Your first choice in burns, chronic wound care and diabetic wound. Irrigation, moisturizing and care products for wound and skin

Similar documents
Actolind. Your first choice for burns, chronic wound care and diabetic wound. Irrigation, moisturizing and care products for wound and skin

DO DIFFERENT WOUND DRESSINGS PROMOTE WOUND HEALING?

AQUIS APPLICATION MANUAL. Anosteralyth-Solution Neutrosteralyth-Solution Anosteralyth-Gel Neutrosteralyth-Gel. Acute and Chronic Wounds

BeneHold Absorbent Wound Dressing Portfolio

EcoHydra Antimicrobial Hand Lotion. Product Overview. Physical Properties. Product Description. Regulatory Compliance. Key Features and Benefits

OxyBAC. Antimicrobial rich-cream foam hand wash. Kills % of many common germs

ABOUT US. Behban pharmed lotus co. is a leading supplier. We have valid international certificates such

Infection prevention. Infection prevention. FoamING sanitizer Liquid sanitizer Foaming soap Lotion soap Lotion. EB LI, (Rev.

Product Classification Borderlines between medicines, cosmetics and biocidal products

ACETOCAUSTIN 0,5 ml, Cutaneous solution

new products 2015/2016

Infection Control Solutions Product Solutions. for Surfaces & Skin

How To Care for Wounds

Chlorhexidine Gluconate Antimicrobial Skin Cleansers TECHNICAL DATA

AneStop Prensentation

BODY PIERCING AFTERCARE:

HI-TEC Alginate Wound Care Dressing

PROFESSIONAL PRODUCTS FOR YOUR HYGIENE AND HEALTH

The fight against infection starts at home.

ADVANCED WOUND CARE PROGRAM

Anatomy of Skin and its Defense, Breakdown, and Fortification

Revised May Appendix B Dressing Selection

Always read the label. Use only as directed. If symptoms persist, see your Healthcare Professional. MUNDICARE, BURNAID and WOUNDAID are registered

Wrinkle/ Fine Lines. Acne/ Blemishes. Pigmentation. Skin Sensitivity/ Redness. The ROOT CAUSE of all Skin Problems is. LACK of MOISTURE!

Range. AU-3528 Oct 16. Page 1

ALLEVYN Gentle Border Lite Advanced Foam Wound Dressings

Topical Skin Care L O O K, F E E L A N D L I V E B E T T E R

50 ML FOAM HAND SANITISER

mediprim gmbh Your contact details:

WHERE HEALING HAPPENS TWO-STEP HOSPITAL-GRADE SYSTEM RADIATION SKIN CARE

smart cleaning proper hearing

Device Performance Quick Guide 1

Hand Hygiene. Policy Title: Hand Hygiene Policy Number: 05. Effective Date: 6/10/2013 Review Date: 6/10/2016

What is infection control?

with Hydrolock Technology

3M Cloth Adhesive Tapes. Commonly Asked Questions

Skin knows the difference

Creams and Lotions. Ointment/Special Creams. Soaps to be used With or Without Water

KILLS BACTERIA, FUNGI & VIRUSES INCLUDING: RINGWORM, STRANGLES, AVIAN FLU, MRSA, E COLI, SALMONELLA TO NAME A FEW...

R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES

Hand Wash. How to. IQ Hand Blue Soap. antibacterial and perfumed. Product Properties. Special Information. Environmental Information

DECON-HAND. Instant Hand Sanitizer. HAND_VL Revised 19 November, Technical Data File

BABY HERBAL COSMETICS WITH NATURAL INGREDIENTS ST. JOHN S WORT HERBAL EXTRACT

The Next Generation of Moist Wound Healing Dressings

A gold medal winner at the 26th Congress of Inventors in Geneva in 1998

Current Status: Active PolicyStat ID: Original Policy: 10/1986 Last Reviewed: 01/2016 Last Revised: 01/2016 Next Review: 01/2019

HAND HYGIENE PROCEDURE ICPR010

BIO & HNT INC. BAL HEALTH ITEM

3M Cavilon No Sting Barrier Film. Realize the potential of proven protection.

Pulpdent Corporation Revision Date: May 1, 2017

TAKING CARE OF THE HANDS

OPTIMIZATION OF PAPAIN-BASED WOUND CLEANSER. by: Sh.Husna Ajlia Sayid Abdullah supervisor: PM Dr Fadzilah Adibah Abdul Majid

Disinfectants in Personal Services Settings

Alamo Hills Advanced Aesthetics & Laser

Ventricular Assist Device (VAD) Exit Site Care Guidelines

English. Address: Exorex Skincare Centre St Thornhill, Ontario Canada L4J 3M8. Telephone: Fax:

Wound Care.

Angel Yeast Cosmetic Ingredients

STACK UP. See how we. Compare Cardinal Health LiquiBand OCTYL Topical Skin Adhesive to other leading products.

The future of disinfection is here

SHEA TECH CERTIFICATION ONLINE COURSE MODULE 3. Grading and Clinical Properties of Shea Butter

Protect. Defend. Nurture.

HydraGeneration Pale rose. The restauration of the hydrolipidic balance

Hand Scrubs Gowning & Gloving

3M Medipore Soft Cloth Surgical Tapes. Commonly Asked Questions

The Safest & Most Effective

Burns. Chapter contents. A) Description of burns. B) Cause of burns. C) Treatment. D) Indications for professional burn care

Croton Oil Peel What is a Croton Oil peel? Peel Preparation During the Peel After the Peel Benefits of Croton oil Skin Peels Exfoliation.

Cleaning and Disinfection Protocol for Emergency Services Fire, Ambulance, Police, Search & Rescue

DNS REVO (DNS80) User Manual EACH DNS REVO WITH ONE LED LIGHT EACH PACKAGE MATCH TWO ROLLERS

NEWS RELEASE. CONTACTS: Investors: Lisa DeFrancesco (862) Media: Mark Marmur (862) Ember Garrett (714)

WOUND CARE/DRESSING CHANGE EBS localized, EBS generalized intermediate, EBS rare others, KINDLER SYNDROME

We understand that a competitor has raised the following issues which we will address in this letter.

HOW DOES DERMA SHIELD WORK?

LEUKOSAN ADHESIVE MSDS No. 189

ANTI-AGEING STEM-CELL SERUM. Lifting, firming & nourishing Serum. FREQUENTLY ASKED QUESTIONS

Instrument Cleaning. Dental Clinics

Dermabrasion. Dermabrasion can decrease the appearance of wrinkles. It can also improve the look of scars, such as those caused by surgery or acne.

Product Solutions. from the makers of

LOW COST HIGH QUALITY

HYAMIRA - JUVEXX. Hyaluronic Acid in Dermatology and Dermocosmetics

INSTANT MEDICAL CARE PRODUCTS

MISSION: CLEAN HANDS 1

Standard Operating Procedures

MATERIAL SAFETY DATA SHEET

Beyond the Book. FOCUS Book

WHAT S HIDING INSIDE YOUR BASIN?

CLINITEX A RANGE OF WIPES, CLEANSING & JANITORIAL PRODUCTS FOR HEALTHCARE PROFESSIONALS

Focus on Quality Care Product Resource Guide

Skin tears and haematoma. Janice Bianchi MSc, BSc, RGN, RMN, Pg Cert Ed

Learning Objectives. Sutures and Staples. Training for Healthcare Professionals. Suture and Staple Removal

Healthy Shine Lilac. For renewed balance and shine

Top Cleansing Power Exceptional Skin Compatibility. Mild and effective skin cleansing at work.

Surgical Hand Disinfection

Chapter 24. Assisting With Wound Care. Elsevier items and derived items 2014, 2010 by Mosby, an imprint of Elsevier Inc. All rights reserved.

CARE OF THE SKIN: GUIDELINES FOR ENSURING SKIN INTEGRITY LESSON PLAN

SAFETY DATA SHEET. CU-2575 Lithium silicate densifier for concrete. Professional use only. (800) (800) Category 2 Category 2


Hand Care Product Systems. Your hands have been in good hands for over 60 years...

Hand Hygiene & PPE Policy

Transcription:

Actolind A New Approach for Wound Care with Smart Molecule Your first choice in burns, chronic wound care and diabetic wound Irrigation, moisturizing and care products for wound and skin

Modern Wound Care Your first choice in burns and chronic wound care Irrigation, moisturizing and care products for skin, mucosa and wound Your first choice for decontamination of patients or personnel contaminating with antibiotic resistant microorganisms (MRSA, MRE, VRE)

CONTENT 4 About Wound 5 Wound Care Guide 6 Polyhexamethylene Biguanide (Polyhexanide) 7 Mechanism of Action 8 Support Wound Healing 9 Poloxamer / Polyhexanide - Poloxamer Combination 10 Actolind w Solution 12 Monodose Innovation 13 Actolind w Gel 15 Usage Table 16 General Hints for Usage 17 Clinical Study Examples 20 Questions & Answers 3

About Wound What is Wound? Wound term is derived from Latin word "vulnus" and described as the disruption of the normal continuity of a body structure (for example, skin) with or without tissue loss. It may accidentally happen due to an injury, a traumatic injury or an intentional surgical procedure. The wounds can be classified according to their starting points: Mechanical Thermal Chemical Radiation Skin Ulcer Which criterias should be considered in selection of preparations to be used on the wound? The products that are used on the wounds of skin, mucosa, etc. should not cause inflammation, kill human cells that help wound healing process, be absorbed by the wound, cross the circulation system. They should be effective on all resistant microorganisms. Do not use any product on the wound that can not be used on the eyes! Prof Dr A Kramer 4

Wound Care Guide Wounds can be classified according to their appearance, reason and contamination condition with pathogenic microorganisms. Wound classification makes easier to evaluate the wound and allows early detection of possible risks. Wound Types Description Product Suggestion Open Wound They are the wounds where cutaneous and subcutaneous tissues are harmed and the skin integrity is damaged in various sizes. Actolind w Solution + Actolind w Gel Clean Wound These wounds do not have pathogenic microorganisms. Clean wounds do not have any tissue loss or infection and their edges unite and they have minimal scar tissue. Actolind w Solution + Actolind w Gel Contaminated Wound There are pathogenic microorganisms in the wound, but any indication of infection has not emerged yet. Open wounds after trauma, excessive bacteria in a sterile body part, which is normally sterile and the wounds having excessive distribution of the content of an organ such as bowel are considered as contaminated wound. Actolind w Solution + Actolind w Gel Infected Wound They are the wounds where pathogenic microorganisms are present. Rash, pain, discharge, bad odor, and other infection indications are seen on the wound. Actolind w Solution + Actolind w Gel Burn Burn means the tissue damage caused by the factors such as heat, electricity, chemicals, boiling water, flame, etc. Extent of the tissue damage depends on the size of burnt area and the continuity of the cause factor. Actolind w Solution + Actolind w Gel Chronic Wound A chronic wound is a wound that does not heal within three months. The wound occurs repeatedly. There is a local or systemic factor that prevents wound healing (e.g., decubitus ulcers). Actolind w Solution + Actolind w Gel 5

A New Approach for Wound Care with Smart Molecule Polyhexamethylene Biguanide (Polyhexanide) It is a new generation smart molecule that is suggested to be the "first choice" in the treatment of chronic wounds and burns. Polyhexanide is a strong cationic raw material with a wide-spectrum. It has polymeric structure with biguanide derivative and shows high compliance with the tissue. Polyhexanide has an incredible advantage over other microbicide substances: it has the highest therapeutic ratio (TB). In other words, the relationship between the benefit and harm is mostly on the benefit side. 6 speciality in 1 product Reliable broad-spectrum antimicrobial effect Continuation of the effect under biological stress Accelerating and supporting effect for wound healing High cell and tissue compatibility No known resistance development against to its effect Low allergy, anaphylaxis and systemic circulation risk 6

Mechanism of Action? Rapid with drawal to bacterial surface Attachment to selective areas on the surface Elimination of bacterial defense mechanisms Reaching bacterial cytoplasmic membrane Cytoplasmic membrane fragmentation and flow of intracellular fluid, electrolytes and macro-molecules out of the cell Bacteria death It shows strong microbicide effects on gram positive and gram negative bacteria, fungi, HPV, HIV, some viruses and amebas. In vitro studies on gram positive and gram negative bacteria have reported that polyhexanide completely kill Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus hirae, Candida albicans, Klebsiella and Enterobacter species in 5-10 minutes. Polyhexanide does not directly affect the body. It does not accumulate in cells and tissues. It is not absorbed by cells or tissues. Polyhexanide, however, binds tightly to the cell wall of bacteria. It permanently damages and weakens bacterias even at very small concentrations. Therapeutic ratio of 25000 is given for staphylococcus aureus. (for comparison: PVP-iodine 500, Octenidine 3,2 and Chlorhexidine 0,9). (Table I ) Active Substance LD50 mouse/mic ratio (impact time 5 min.) Staphylococcus aureus Pseudomonas aeruginosa Chlorhexidine 0,9 0,9 Octenidine 0,2 0,2 Benzalkoniumchlorid 8,0 2,0 PVP iodine 500,0 1000,0 Polyhexanide 25000,0 200,3 (Table I) 7

Support Wound Healing How Does It Support Wound Healing? Polyhexanide accelerates wound healing at microbicide concentrations. The common feature of wound care products is that they damage both bacteria and human cells without considering any difference between them. The basic principle in wound healing is non-blocking of the wound healing cell functions. While polyhexanide damages the bacteria, does not destroy the structure of the healthy cell and does not have any toxic effect on the cell. The basic proof of that is the study on keratinocytes. In a study of polyhexanide keratinocytes*, it is shown to increase keratinocyte production at a concentration of 0.2 microgram/ml. In another study made on pigs, it is shown that polyhexanide accelerate wound healing. The most outstanding effect of polyhexanide in performed studies is having antimicrobial effect against the resistance bacteria such as MRSA, VRE, and Acinetobacter *These cells, which form the largest part of the epidermis and hair follicles, are responsible for keratin synthesis in the stratum corneum or hair shaft. Keratinocytes occur in the basal layer of the epidermis and reproduce by mitosis. They produce lipid, NMF and keratin when they go to the skin surface. In this process, keratinocytes f latten, lose their nuclei and die. In later stages, these cells are known as corneocytes. 8

Poloxamer Poloxamers can be used therapeutically in eye drop formulations, in the treatment of kidney stones, and as skin wound cleaners. Why Is Poloxamer Used As Surfactant? The polyhexanide matter only tends to protect its features when it is used with the amphoteric and non-ionic surfactants in wound healing compounds. According to European Union Regulation (EC) nr. 66/2010, the usage restrictions are put forward because the recycling of surfactants and their toxic levels on creatures are higher in nature. According to the current legislation, some problems are emphasized in terms of biodegradability of cationic and amphoteric surfactants (including amphoteric alkali betaines) in aerobic and anaerobic conditions. Polyhexanide-Poloxamer Combination The use of polyhexanide in combination with a surfactant (Poloxamer) plays a crucial role in the wound cleaning. Wound cleaning is achieved by removal of visible contaminants and reduction of bacteria. To start wound healing, any contaminant should be removed from the wound. Polyhexanide-poloxamer combination has an excellent cleaning effect. It is well tolerated by the cell. Due to the modified surface tension, the formulation also reaches areas where water cannot penetrate. In this way, it penetrates the deepest areas and provides much better effect than classical antiseptics. Bacterial residues and other wastes do not remain on the skin in contrast to other antiseptics and they are safely removed from the wound. 9

Actolind w Solution Support the treatment Help to shorten the recovery time Make easier the removal of antibiotic resistant organisms such as MRSA-MRE-VRE from the wound surface Dermatologically tested Helps to removal of biofilm Accelerate the granulation and epithelization Biocompatible Actolind w Solution is clear, colorless and odorless. It is ready to use. It contains Polyhexanide as active substance and Poloxamer as auxiliary substance. It is used for mechanical cleaning, irrigation and moisturizing of acute, chronic and infected wounds, 1st and 2nd degree burns. It can be applied directly to the wound area, or it can be used by applying on a gauze or bandage as a medical device. 10

Usage Area Actolind is used for washing and irrigation of the wound before the bandage. Actolind is suitable for washing and moisturizing of the wound with the bandage. Actolind stabilizes the wound through filling it. Actolind is used for moisturizing and decontamination of the bandage, gauze, compress and wound fillers, which are dried, adhered to the wound and contaminated, before they are removed from the wound surface. Actolind ensures easy replacement of the dressing, and preventing the prolongation of healing process by reopening the wound. It is suitable for wound care according to the wound type: Acute wounds (traumatic wounds as a result of cuts, tears, peeling, crushing, biting, stabbing, etc. or surgical wounds) Chronic wounds (diabetic ulcers, venous ulcers, bed (pressure) wounds, etc.) Thermal or chemical burns and injuries (1 st and 2 nd degree burns, chemical burns, etc.) Wounds as a result of electric current Radiation wounds Insertion sites of urological catheters Stoma care; cleaning, irrigation and moistening of fistula and apsis Chemical components of Actolind w Solution: % 0,1Polyhexanide (PHMB), Poloxamer and auxiliary substances Art. No Unit Packing Type Number in a Package 06.6703.03 3 ml Monodose 100 x 5 06.6703.05 5 ml Monodose 100 x 5 06.6703.10 10 ml Monodose 50 x 5 06.6703.50 50 ml Bottle with spray cap 200 06.6703.100 100 ml Bottle with spray cap 100 06.6703.250 250 ml Bottle with spray cap 40 06.6703.500 500 ml Bottle 20 06.6703.1 1000 ml Bottle 10 11

MONODOSE Innovation When it is considered in hygienic terms, disposable products are used to minimize the transition of microorganisms to the patients and the exposure of medical personnel to pathogens, especially. These products are designed to prevent cross infection in the transition from patient to patient. As the importance given to the compliance with health rules in the world increases, the use of monodose materials have become increasingly widespread. Monodose products are the best choice for hygiene as they are personalized for medical officials and users. It provides usage of correct dosage and prevents excessive consumption of the product. 12

Actolind w Gel Therapeutic support Assist in shorten the recovery period Facilitates the removal of antibiotic-resistant microorganisms such as MRSA-MRE-VRE from the wound surface Dermatologically tested Assist in prevention of biofilm formation Assist in acceleration granulation and epithelialization Biocompatible Actolind w Gel is clear, colorless and odorless. It is ready to use. It contains polyhexanide as active substance and poloxamer as auxiliary substance. Actolind w Gel is used for the mechanical cleaning and moisturizing of chronic and infected wounds, also 1 st and 2 nd degree burns and helps to accelerate the healing. It can be applied directly to the wound area, or it can be used by applying it on a gauze or bandage as a medical device. 13

Usage Area Keeping the wound clean and moist with the dressing, stabilizing by wound filling Easy dressing change, prevention of wound reopening and prolonged healing process Wound care according to the wound type, it is suitable for Chronic wounds (diabetic ulcers, venous ulcers, bed (pressure) wounds, etc.) Thermal or chemical wounds (e.g. 1st and 2nd degree burns, chemical burns, etc.) Wounds as a result of electric current Radiation wounds Chemical Components of Actolind w Gel : 0,1% Polyhexanide (PHMB), Poloxamer, and auxiliary substances Art. No Unit Packing Type Number in a Package 06.6803.30 30 ml Tube 240 06.6803.50 50 ml Tube 200 Actolind w Solution / Gel Biocompatibility Biocompatibility Evaluation: Irritation Test Report Cytotoxicity Test Report Sensitivity Test Report (ISO 10993-10 Biocompatibility Test Report) (ISO 10993-5 Biocompatibility Test Report) (ISO 10993-10 Biocompatibility Test Report) Biofilm Effect Poloxamer is a well-known, non-toxic and non-sensitizing surfactant. It reduces the surface activity on the wound surface and facilitated the removal and destruction of biofilms, dirt and necrotic tissues. PHMB is an antimicrobial agent and prevents biofilm formation by inhibiting microbial growth. In line with this information, the formulation of Actolind w Solution/Gel prevents biofilm formation due to its formulation containing PHMB and poloxamer. 14

Usage Table Wound Type Actolind w Solution Actolind w Gel Packing Type Usage Use in acute woundse.g.: traumatic wounds as a result of cut, tear, peel, crush, bite, stabbing, etc. or surgical wounds X Actolind w Solution 50 ml 100 ml 250 ml Apply directly to the wound. Spray it 5 times and leave it open or closed according to the wound condition. Use in chronic wounds - e.g.: diabetic ulcers, venous ulcers, bed (pressure) wounds X X Actolind w Solution 500 ml - 1000 ml Actolind w Gel 50 ml Diabetic foot- (if it is amputee): Wet dressing should be done with Actolind w Solution once or twice a day. Actolind w Gel should be applied and covered with gauze. In this way, the contact between the wound and air is blocked, so that the wound is not infected. Chronic wound: The wound is assessed according to its depth and size. It is cleaned by using Actolind w Solution. Actolind w Gel is applied as a thin layer and the wound is covered. Before re-opening the wound, the gauze on the wound is wetted with Actolind w Solution and it is removed. Duration and number of usage is evaluated by a doctor and the appropriate time period is determined. Use in burns e.g.: Thermal or chemical wounds 1st and 2nd degree burns, chemical burns, etc. X X Actolind w Solution 500 ml - 1000 ml Actolind w Gel 50 ml Use as a result of electric current X X Actolind w Solution 500 ml - 1000 ml Actolind w Gel 50 ml Use in radiation wounds X X Actolind w Solution According to status of the wound 250 ml or 500 ml Actolind w Gel 50 ml Depending on the depth, type and size of the burn, the burn is washed with Actolind w Solution. Actolind w Gel is applied and the wound is left open. Depending on the depth, type and size of the burn, the burn is washed with Actolind w Solution. Actolind w Gel is applied and the wound is left open. Depending on the depth, type and size of the burn, the burn is washed with Actolind w Solution. Actolind w Gel is applied and the wound is left open. Use in the cleaning and cleaning of insertion sites of the catheters X Actolind w Solution 50 ml 100 ml 250 ml Before the catheter insertion, while the catheter is inserted or after the catheter is removed, Actolind w Solution is applied directly to the area by spraying 5 times. Insertion site of catheter is wiped from the center to the periphery with a gauze or compress. Stoma care; cleaning, irrigation and moistening of fistula and apsis X Actolind w Solution 50 ml 100 ml 250 ml Actolind w Solution is applied directly to the area by spraying 5 times. It is wiped from the center to the periphery with a gauze or compress. Use in the moisturizing of bandage, gauze, compress and wound fillers, etc. before the practice X Actolind w Solution All packaging types according to dressing size Actolind w Gel 50 ml Dressings and bandages are wetted with Actolind w Solution before being replaced. Before the dressing replacement, Actolind w Gel is applied to the wound and the wound is closed. Use in moisturizing and decontamination of the bandage, gauze, compress and wound fillers, which are dried, adhered to the wound and contaminated, before they are removed from the wound surface X Actolind w Solution All packaging types according to dressing size Before replacing wound dressings, all dressings and bandages are wetted with Actolind w Solution. 15

General Hints for Usage Aseptic techniques must be taken into consideration before using Actolind group products. Actolind -Wound Products should not be mixed with other soaps, ointments, oils or enzymes as it may reduce protective effect. In order to remove these kinds of products completely from the wound, it should be washed thoroughly with Actolind w Solution. Actolind w Solution/Gel can be applied directly to the area/wound surface to be cleaned, or on the bandages, gauzes, etc. Products such as bandages, gauzes, wipes should not be used again. The bottle should be closed immediately after use in order to prevent contamination. Actolind w Solution/Gel and has 8-week shelf life after opening. The mouth of bottle/tube must be protected in order not to cause contamination during use. Bottles that are in direct contact with the wound or otherwise contaminated should be destroyed. Actolind w Solution should be heated before use until it reaches body temperature. Opened product should be used only for one patient in order not to cause any contamination. If the patient has sensitiveness against any content of the product, the product should not be used. 16

Clinical Study Examples Summarized results of positive feedbacks and evaluations about the clinical studies of the product are presented to your attention. 1. Actolind Experience after Z Plasty Application to Contracture Bands on Burned Arm Subject: A tissue healing case is presented. Actolind w Solution is used after Z plasty application with the purpose of opening contracture bands resulting from the burns. Period: 70 days Result: Actolind w Solution/Gel is attached to the phospholipids in bacteria cells due to its polyhexanide structure and mechanism of effect. It does not penetrate into healthy cell due to its big molecule structure. This antiseptic feature prevents microorganism reproduction and keeps the wound moist and lets the formation of new tissues. Poloxamer, as its content, effectively cleans the wound and prolongs the action time of Polyhexanide. In this case, the repair process continues although it is on the 70th day. Starting date of Actolind w Gel and Solution usage 10.09.15 70 th day of Actolind w Gel and Solution usage 19.11.15 17

2. Actolind Experience in Burn Treatment Subject: 23-year-old male patient has 2nd degree burn on his right arm due to boiling water spillage Period: 10 days Result: The wound is washed with Actolind w Solution. It is seen that infarcts are removed from the healthy skin after washing. Infarcts are debrided. Actolind w Gel is covered whole wound area properly. Complete recovery is achieved in 10 days. 18

3. Actolind w Experience in Venous Ulcer Treatment Subject: 62-year-ol female patient having Type 2 DM and ulcer as a result of venous failure on the area operated 7 years ago Period: 82 days Result: Dressing is done by using Actolind w Solution and Actolind w Gel together with triple bandage system. Complete recovery is achieved in 82 days. 4. Actolind w Gel Product Experience Subject: In that study, a patient who had chronic wound complaints for ten years and A. baumannii reproduction is presented. The patient recovered with the help of suitable isolation techniques, asepsis/antisepsis, nursing care and surgical methods. Period: 08.08. 2008-27.08.2008 Result: A. baumannii reproduction which is the cause of infection in the patient is stopped. Wound healing is objectively recorded with the photos taken during the healing process. It is found that following steps increase the healing process; Caring of asepsis/antisepsis techniques in chronic wound care and dressings, Isolation of the patients, who has reproduction in culture result, Use of Actolind w Gel and correct surgical techniques. 19

Questions / Answers Q: What should I know about the anatomy and physiology of the skin? A : Skin, the largest organ of human body, covers 2 square meters area and can weigh 10 kg. It internally protects the homeostasis and acts as a protective barrier against the outside environment. The skin consists of two main layers, epidermis and dermis, which lay over a fatty layer called hypodermis (subcutaneous tissue). Respectively, epidermis and dermis consist of lower layers. The area where the epidermis adheres to the dermis is called the dermal epidermal connection point. The oxygen between the vascularized dermis and the avascular epidermis is responsible for the exchange of nutrients and wastes. The skin has many important functions. One of them is to be a protective barrier against external environment such as chemical or mechanical wounds or ultraviolet radiation. Its other function is to be sensitive against the pain, touch, pressure and heat. Q : How does a wound heal? A : Wound healing is a complex and dynamic process that ideally leads to restoration of anatomic continuity and function. The process starts the moment of injury and has a series of condition which can last for months or years. The wound healing process can be divided into three stages: (1) Inflammatory, (2) Proliferation and (3) Remodeling. These three processes are carried out automatically by the immune system of a person who does not have any problem in immune system. That means every wound that is kept clean and moist heals spontaneously over time. Q : What is the difference between an acute and chronic wound? A : Acute injuries are usually traumatic or surgical. Generally, these injuries occur suddenly, healing process is fast and normal wound healing ideally processes without any major complication. Examples of acute wounds are ruptures, animal stings or knife wounds. A chronic wound can be defined as a wound that is stuck in one or more of the normal wound healing processes (usually the inflammatory phase). Acute wounds heal quickly and properly when they are compared to chronic wounds which have characteristic features. Most of the chronic wounds can be divided into three categories: venous ulcers, diabetic ulcers and pressure ulcers. Q : What is wound care? What is its benefit? A : A qualified wound care is achieved by preventing wound infection, trauma or contract with highly malignant agents and by avoiding from the conditions which may cause another surgical intervention. For this reason, it is necessary to keep the wound clean, moist and to disconnect from the external environment against the infection factors. Q : What is the aim of wound care? A : 1. To protect living tissues 2. To prevent excessive tissue destruction and infection development in traumatic area. 3. To shorten the healing process The wound automatically and rapidly heals in a patient who has a normal and healthy immune system thanks to a good wound care practice. A good wound care recently has gained importance because it accelerates up the healing process and shortens the hospitalization period and many product has been put into market in the last years. In other words, wound care is highly important both for the patient and for the economic terms. Q : How are the products classified? A : Actolind w Solution and Actolind w Gel is categorized as Class III Medical Devices according to European Union Medical Device Directive 2007/47/EC (MDD). Class III device design/clinical trial examinations require the product certificate and an evaluated quality system. All documentations of third class products and systems are performed by a body authorized by European Commission. Q : Why are Actolind w Solution and Actolind w Gel medical products? A : When a product is classified, all relevant regulations must be considered. Actolind w Solution and Actolind w Gel products remain between the medical device and the drug products when it is evaluated in this context. Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices -Version 1.18 (12-2017) and Meddev 2.1/3 rev 3 Guidance are based on for the classification of byproducts. When these two documents are examined: Wound dressings may be in the form of liquid gels and pastes, etc. (e.g. hydrocolloid and hydrogel) It is seen that the products such as irrigation solutions intended for mechanical rinsing (e.g. bladder irrigation solution, ocular irrigation solution etc.) are classified as medical devices. The main purpose of Actolind w Solution and Actolind w Gel is to keep the wound clean and moist. However, the dry and crusts adhered to the bandage and dead tissues provide a suitable environment for infection development. Polyhexanide is used as a protective antibacterial substance 20

to prevent that bacteria penetrates from dressing to the wound. The polyhexanide forms a protective film layer between the wound and the dressing. This layer cuts off the connection with the external environment and prevents the penetration of bacteria from outer environment to the wound. Unlike drugs, polyhexanide does not have any medical or immunological effect on the cell or bacteria. The polyhexanide binds to acidic phospholipids of bacteria cell wall through electrostatic interaction. Due to all these reasons, it has been certified as a Class III product and defined as a medical product. Q : What are the formulations of Actolind w Solution and Actolind w Gel? A : Actolind w Solution contains a surfactant, Polyhexanide (PHMB) and pure water. In addition to that, Actolind w Gel has also moisturizing effect. Q : What are the advantages of Actolind w Solution and Actolind w Gel? A : Combination of surfactant (Poloxamer) and Polyhexanide - Shortens the healing period by keeping the wound clean and moist - Due to the large molecular structure of polyhexanide, the product, which is not absorbed by the skin, forms a protective film layer on the wound surface. Polyhexanide film layer with antibacterial effect cuts off the connection with outer environment and prevents the bacterial growth on wound surface. Thus, it keeps the wound surface stable. - Filling the gap between the skin and the sticking plaster, compress, gauze and other materials and creating a film layer on the wound surface increase the efficiency of these materials. - Healing process is shorten by keeping the wound always moist and not letting the creation of scabs, which is adhered to the dressing, or rupturing these scabs during the dressing change, or letting its reoccurrence. - It prevents the adhesion of dressing to the wound by wetting it before chancing the bandage during the dressing. Therefore, the dressing is removed more easily and the patient does not have any pain during the dressing change due to the rupture of scabs adhered to the wound. Q : Do Actolind w Solution and Actolind w Gel help debridement? If yes, how? A : Yes. Poloxamer, a surfactant, and the moisturizing agent. Glycerin softens the scab and necrotic tissue on the wound surface. Thus, it helps to remove the necrotic tissue from the wound surface by washing, softening and loosening and then removing the necrotic tissue. Q : Question: What is the usage procedure/protocol? A : Actolind w Solution: To loosen and remove the wound covers; wet the bandages with the product (compress, bandage, gauze, etc.) and wait for 10-15 minutes to let the scabs soften and loosen. Then, remove the loosened material and wash the wound with Actolind w Solution. Actolind w Solution will clean the wound surface and create a protective film layer. Then, replace the bandage and end the dressing procedure. Actolind w Gel: Apply it to the wound after the wound is cleaned with Actolind w Solution. It is a «leave on» product and will create a protective film layer on wound bed. This lets the scabs and necrotic tissue, which are difficult to remove, to be softened. Leaving the gel on the wound provides a continuous cover. Thus, the connection between the wound and outer environment is cut off. Efficiency of bandage is increased because the wound surface is filled well. Due to this protective later, the wound surface is protected from the infection and the wound is kept stable by preventing bacteria growth on the surface. In case of small and surface wounds, only use Actolind w Solution. In case of big and deep wound, wash the wound surface with Actolind w Solution and then fill the wound surface with plenty of Actolind w Gel, and then apply the bandage. Q : How long are Actolind w Solution and Actolind w Gel used on the wound? A : There is not any limit for the use of Actolind w Solution and Actolind w Gel. They are especially designed for the treatment of the wounds which require long healing period. 21

Also Actolind Group has following products: ACTOLIND w / GENİTAL GENITAL CARE PRODUCTS Cleaning, moistening and Anti-itching for perineal area. Free of alcohol! ACTOLIND w / MOUTH DENTAL AND ORAL CARE For oral mucosal infections and wounds. Induces good and fresh breath. Erases plaque. Free of alcohol! ACTOLIND w / BABY SPRAY/GEL BABY PROTECTION SPRAY/GEL FOR THE DIAPER REGION It nourishes the skin, prevents dehydration, reduces and eliminates skin tension. Free of paraben! Tested and certified by the German Dermatest Institute. ACTOLIND / FOAM BODY SKIN CARE & CLEANSING FOAM Gentle cleaning of contaminated and impure skin. Removes bad smell and decreases germs. Please contact us for detailed information. 22

NOTES :

ACTO GmbH Head Office Büchnerstrasse 11 38118 Braunschweig / Germany Bayern Branch Balthasar - Neumann Str. 4 / 97204 Höchberg / Germany Baden Württemberg Branch Untere Hauptstr. 6 / 78573 Wurmlingen / Germany www.actogmbh.com info@actogmbh.com +49 (0) 531-239 508-0 +49 (0) 531-239 508-11