USA 1-800-227-2862 (BBRAUN2)

FAQs

   

Being the largest human organ, the skin covers almost an area equivalent to 2.5 square feet and can weigh up to 22 pounds. It serves as a protective barrier against the external environment while maintaining homeostasis internally. The skin is made up of two major layers, the epidermis and the dermis which rest on a fatty layer called hypodermis (subcutaneous tissue). The epidermis and dermis are in turn composed of sub-layers. The area that anchors the epidermis to the dermis is called the dermal-epidermal junction. It is responsible for the exchange of oxygen, nutrients and waste products between the vascularized dermis and the avascular epidermis.

The skin has many important functions:

    • Social importance: appearance and identification of a person
    • Protection: protective barrier against the external environment such as chemical or mechanical injuries or ultraviolet radiation and maintenance of a homeostasis internally
    • Sensation: sensitive to pain, touch, pressure and temperature
    • Thermoregulation: through dilatation and constriction of vessels and sweating
    • Metabolism: synthesis of Vitamin D (calcium and phosphate metabolism) in the presence of sunlight 

The term wound is derived from the Latin word “vulnus” and can be defined as a disruption in the normal continuity of a body structure (e.g. skin) with or without tissue loss. A wound can accidentally result from a traumatic injury or intentionally from a surgical procedure.

Wounds can be classified by their origin (see Glossary for definitions of each type):

  • Mechanical
  • Thermal Chemical
  • Radiation
  • Skin ulceration

Wound healing is a complex and dynamic process that ideally leads to restoration of anatomic continuity and function. The entire process is a series of overlapping events that begins at the moment of the injury and can last for months to years. The wound healing process can be divided into three phases: (1) Inflammatory, (2) Proliferation and (3) Remodelling.
 

Acute wounds are typically traumatic or surgical in origin. Usually, these wounds occur suddenly, move rapidly through the wound healing process and ideally lead to normal wound closure without causing major complications. Examples of acute wounds are lacerations, animal bites or stab wounds.

Chronic wounds can be described as a wound in which the normal wound healing process is stuck in one (usually inflammatory phase) or more points of the wound healing phases. Chronic wounds have characteristic features and compared to acute wounds, they fail to heal in a timely and orderly manner.
 

Prontosan irrigation solution and gel are not drugs. They are categorized as Class II medical devices.

  • A medical device is a product which is used for medical purposes in patients, in diagnosis, in therapy or in surgery. If applied to the body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs, which exert a biochemical effect.

There are three classifications of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Explanation of Class I, II and III are as follows:

  • Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I devices are subject only to general controls such as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. Devices in this category include tongue depressors, elastic bandages, hand-held dental instruments, examination gloves, hand-held surgical instruments and other similar types of common equipment.

  • Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material.

  • Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through the general or specific controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device’s safety and effectiveness, in addition to the general controls of Class I. Examples of Class III devices include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generator and intra-bone implants.

Prontosan solution and gel contain undecylenamidopropyl Betaine and Polyhexanide (PHMB) as active ingredients and purified water. Additionally, the gel contains glycerol and hydroxyethylcellulose.
 

Prontosan is a sterile, colorless, odorless and ready-to use product. It is easy to use and can be warmed up to body temperature prior to application.
 

Prontosan Wound Gel and Prontosan Wound Irrigation Solution can be used in all types of wounds. There is no restriction.
 

Yes. Betaine helps to remove wound coatings including slough and necrotic tissue by softening, loosening and subsequent detachment.
 

Solution: Squeeze directly from the bottle to remove already loose wound coatings. Wet a compress and leave it on the wound for 10-15 minutes, or per your facility’s protocol, to soften and loosen wound coatings. Subsequently, the loosened material can be washed away with Prontosan.

Gel: Apply the gel after cleansing the wound with Prontosan solution. The gel is a “leave on” product and will create a film on the wound bed. This ensures softening of hard-to-remove coatings. Leaving the gel on the wound provides a “continuous” coverage (for additional information, refer to Prontosan Sell Sheet).

The PSI for the 350 mL bottle is up to 7 PSI. According to research reported in Medtech Insight 1997 (Chapter 3, pp 71-72), a PSI between 4-15 is required for adequate wound irrigation and cleansing. Spray bottles only produce up to 1.5 PSI. Prontosan does not need to be transferred to another container (like a syringe) to produce adequate PSI.
 

There is no limit to the length of time that Prontosan can be used in the treatment of wounds. In fact, Prontosan is especially designed for the long term treatment of hard-to-heal wounds.
 

Prontosan has been sold in Europe for more than 4 years and was made available in the US in September 2009.
 

Due to its “unique” combination of Polyhexanide (PHMB) and Betaine, there is no direct competition (see competitive matrix for additional details).
 

Solution: 28 days
Gel: 28 days

Important:  Prontosan does NOT need to be refrigerated to maintain shelf life. Other irrigation products are being used “cold” on a wound because they are being stored in a refrigerator to maintain shelf-life.
 

Yes. The Solution received FDA clearance in October 2008. The Gel received FDA clearance in March 2009.

From any established B. Braun distributor. If the distributor of their choice does not have Prontosan in stock, customers should request that the distributor order it for them.
 

The HCPCS Codes for Prontosan are as follows:

  • Prontosan Wound Irrigation Solution (400441 and 400440) HCPCS code is A6260
  • Prontosan Wound Gel (400560) HCPCS code is A6248

NOTE: B. Braun does not provide any reimbursement advice. It is the responsibility of the healthcare professional or entity to ensure the accuracy of the information they submit to the government or any third party relating to the reimbursement of their costs for products or services they provide to their patients.
 

Pricing should be communicated to the customer from the distributor.

Prontosan is produced using a “blow, fill, seal” process. The production line “blows” the plastic material into the designated size container (30 mL, 40 mL and 350 mL), and then the containers are “filled” with Prontosan before being “sealed” completely. Other than the single use 40 mL vial size, the Prontosan 30 mL and 350 mL containers can not be used until the spike, integrated into the top inside of the cap, pierces the container by screwing the cap tightly on to the container in a clockwise motion. The white ring collar on the 350 mL container must be removed prior to tightening the cap.

Yes. Prontosan containers are PVC-free, DEHP-free as well as Latex-free.