Product features:

Prontoderm solution
For MRE decolonization of skin and mucous membranes through physical cleansing

Product description:
Prontoderm solution for MRE decolonization through cleansing and care of skin, mucous membranes and hair.

Characteristics:

• Proven antimicrobial barrier effect for up to 24 hours reduces the likelihood of recolonization.
• It does not need to be rinsed, thus saving time and money.
• Very good skin compatibility
• Painless application
• Eliminates odors
• Planned for long-term use
• Indications: MRE – Decolonization of skin and mucous membranes

Introduction:
Multidrug-resistant organisms (MDROs) such as MRSA (methicillin/multidrug-resistant Staphylococcus aureus), VRE (vancomycin-resistant enterococci), or ESBL (extended-spectrum beta-lactamase) are increasingly causing problems in healthcare and have a serious societal impact (e.g., community-acquired (CA) MRSA). MDROs can colonize the skin. This colonization must be avoided under all circumstances, especially before surgical procedures, in catheterized, or immunocompromised patients, to prevent serious problems such as infections. The goal is to reduce the incidence of such infections through decolonization. This instruction leaflet shows how decolonization can be performed quickly and easily using the Prontoderm product family.

Indications for the Prontoderm product family:

• MRE – Decolonization through physical cleansing.
• Suitable for use in medical settings.
• Suitable for preoperative cleaning.
• Persistent antimicrobial barrier effect to prevent recolonization by transient flora.
• Inhibition of the growth, spread and transmission of MRE.
• Odor reduction.

Indications for ProntOral:

• MRE – Decolonization of the oral cavity and pharynx through physical cleansing.
• Prevention of plaque formation, caries, periodontitis and gingivitis.
• Suitable for use in medical settings.
• Persistent antimicrobial barrier effect to prevent recolonization by transient flora.
• Inhibition of the growth, spread and transmission of MRE.
• Suitable for patients with damaged mucous membranes (e.g., after oncological radiation or chemotherapy). Intended users: physicians, nursing staff, family members, and the affected patient themselves after appropriate instruction. For use in hospitals, nursing homes, and at home.

Preparation:
Prontoderm products or ProntOral must not be mixed with other soaps or solutions. Prontoderm products are ready to use. Prontoderm Wipes can be used instead of washcloths soaked in Prontoderm solution and can be warmed in the microwave before use. Prontoderm solution can be warmed to body temperature before use (e.g., in a water bath or incubator).

Application:
Full body cleansing and decolonization of immobile patients:
Depending on the patient's size, approximately 300-500 ml of Prontoderm solution is required. Rinsing after application is not necessary (leave-on product). Patients are cleaned with fresh washcloths thoroughly soaked in Prontoderm solution. At least eight fresh, clean washcloths are needed for this purpose. Several cotton swabs are also required, for example, for use in the ears and nose. After each step, the washcloths and/or cotton swabs are either discarded or reprocessed, and fresh items are used for the next step. Once one side of the body is completely cleansed, a fresh linen sheet is placed under the patient, and then the other side is treated as described below.

1. Oral care: Soak dentures in Prontoderm solution for at least 15 minutes, remove any adhering debris with a brush, then rinse with water. Use ProntOral to rinse the mouth and throat. Gargle several times a day for 30 seconds (60 seconds in the case of MRSA) with approximately 10 ml of undiluted solution, do not swallow, and do not rinse afterwards.

2. Nose: Thoroughly clean the nose with Prontoderm Nasal Gel and a cotton swab. Clean the nose, and especially the vestibule, thoroughly at least 3 times a day. Prevent the formation of firmly adhering crusts to minimize the nutrient base for possible recolonization.

3. Hair washing: Use a soaked washcloth. After 3-5 minutes, carefully dry your hair with a clean towel. If desired, then wash your hair with a shampoo of your choice.

4. Face: Thoroughly wet all skin areas with Prontoderm solution. Keep eyes closed during the procedure. Gently cleanse the area around the eyes and eyelids. After 1-2 minutes, dry the cleansed skin with a fresh, clean cloth.

5. Ears: Clean the outer ear with a cotton swab moistened with Prontoderm solution. Caution: Prontoderm solution or other cleaning solutions must not flow into the inner ear.

6. Torso: Clean the upper body from the neck downwards, using a fresh cloth for the chest/abdomen and back. After 1-2 minutes, dry with a fresh, clean towel. Wipe arms from the fingers to the shoulders with a fresh washcloth each.

7. Legs: Clean legs from the hips to the feet using a fresh washcloth each time.

8. Genital area: Several washcloths may be needed to clean the lower body in order to completely eliminate odors.

9. Urethra and catheter entry points: Clean the access points of indwelling catheters with moistened cotton swabs and dry with new cotton swabs after 1 minute. Work from the inside out.

Decolonization of mobile patients and staff:
Shower with warm water for 1-2 minutes. Turn off the shower and generously apply Prontoderm Shower Gel from head to toe, covering all parts of the body, including the hair, like liquid soap. Avoid getting the gel in your eyes. After 1-2 minutes, rinse with warm water and dry your body with a fresh, clean towel.

Other items:
All other items, such as glasses, jewelry, prostheses, etc., can be rubbed with Prontoderm solution or wipes for decolonization. Plastic items should be rinsed with drinking water after an exposure time of approximately 5 minutes.

Application time:
In accordance with current MDRO decolonization guidelines. Unless otherwise instructed by healthcare professionals, Prontoderm products should be used for a maximum of 15 days (1 to 3 decolonization cycles of 3 to 5 days each).

Supportive hygiene measures:
Recommended to reduce the risk of recolonization and transmission: hand disinfection (e.g. with Softa-Man, Softalind) before and after patient contact, disinfection of all surfaces (e.g. with Hexaquart, Meliseptol), wearing protective clothing, etc.

Technical specifications:
The efficiency and residual effect of the Prontoderm product family and ProntOral have been demonstrated in vitro and in clinical practice.

Prontoderm solution, foam, wipes for full body cleansing:
0.11% polyaminopropyl biguanides (polihexanides), surfactants, excipients

Prontoderm Nasal Gel (thin gel) for nasal decolonization, Prontoderm Shower Gel (thick gel) as a shower gel for mobile patients and staff:
0.1% polyaminopropyl biguanides (polihexanides), glycerine, hydroxyethyl cellulose, excipients

ProntOral mouthwash:
0.15% Polyaminopropyl Biguanide (Polihexanide), Aroma, Sodium Cyclamate, Surfactants, Excipients

Side effects:
In very rare cases, dry skin or a mild burning sensation may occur after using Prontoderm solution or foam, but this disappears after a few minutes. Contraindications: The Prontoderm / ProntOral product family must not be used in patients who are known to be allergic to any of the ingredients, or if such an allergy is suspected. Do not use the products in the middle or inner ear or in the eyes!

Do not use in combination with anionic surfactants, as this may impair preservation. Remove any soap or washing residue from the skin with water before applying Prontoderm. Avoid using other products simultaneously with Prontoderm products.

Application limitations:
Pregnancy and breastfeeding:
No data are known indicating mutagenic or embryotoxic effects of the ingredients. Since polihexanide is not systemically absorbed, passage of the substance into breast milk is unlikely. However, due to insufficient clinical experience with pregnant and breastfeeding women, newborns, and infants, Prontoderm/ProntOral should only be used in these cases after careful clinical evaluation.

General safety instructions:
For use only on intact skin and mucous membranes. Not for infusion or injection! Do not swallow. If swallowed, rinse mouth, drink plenty of water, and consult a doctor. In case of contact with eyes, rinse thoroughly with plenty of water, including under the eyelids. If eye irritation persists, consult a specialist.

Close the container immediately after each use. Use only undamaged bottles. Dispose of any leftover Prontoderm Wipes after use. Keep bottles away from direct sunlight.

Medical device - keep away from children!

Environmental information:
Prontoderm / ProntOral products can be safely disposed of via wastewater and have no known negative effects on the wastewater system.

Package size:
1 piece

Source: Information from the package insert
As of August 2016