Dry mouth & wounds – HydraFilm
Physiopathology:
Xerostomia (Dry mouth) often develops when the amount of saliva that bathes the oral mucous membranes is reduced due to poor salivary gland secretion. This condition is frequent in patients at the end of life: Cancer patients under chemo or radiotherapy; Patients suffering from debilitating diseases; Palliative care patients.
Wound dryness is common in patients suffering from Bedsore, Diabetic ulcers, Chronic leg ulcers, & Post-operative wounds.
These conditions severely deteriorates the Quality of Life of the patients
Epidemiology:
Nearly 80% patients towards the end of their life experience mouth dryness. All the open wounds present a risk of surface dryness which may delay healing & aggravate sufferings.
Ideal Treatment Approach:
An ideal treatment should be: Long-lasting (at least a few hours) hydration, Non-irritant, Easily applicable, Cell friendly : Should not interfere with cellular growth & healing, Anti-bacterial: Should not act as a medium for microbial growth, Dual acting: Hydrating & cell growth stimulating, Avoid dressing: Possibilities to apply anywhere in mouth / wound, Reduce pain: Hydrating & cleaning the surface should reduce pain, Non-chemical: to avoid drug interactions & to allow cell growth (healing), Not very expensive, Totally safe, & can be used at home by the patient. Wound healing requires OXYGEN & a clean environment. If the wounds are closed, healing stops & anaerobic bacteria grow & if wound is kept open, secondary infection hampers healing.
A filmogen Medical Device spray for instant & long-lasting hydration of Dry mouth & Dry wounds
Currently Available Treatments:
In spite of widespread occurrence and a huge demand, up till now, the problem of dry mouth & dry wounds was not considered as a disease and no serious efforts were made to find an ideal treatment. Water or normal saline sprays in mouth or on the wound surface or application of Vaseline on the injured surface, are common treatments. Antiseptic solutions are also employed on infected injuries.
VITROBIO’s NEW Therapeutic Approach:
Vitrobio invented and patented an osmotically active, hypertonic, antiseptic but cell friendly solution for topical application. The solution was further rendered filmogen for a long-lasting adherence on the biological surfaces. When sprayed on the tissue surface, the film instantly attracts hypotonic liquid from the inner parts of the tissue, keeping the surface permanently hydrated. The osmotic liquid flow equally detaches & drains all the contaminants (including microorganisms, free virus particles, cell debris, protein molecules) from the surface. When the surface is clean, healing starts immediately. When applied on a wound surface, the film does not allow microbial growth, keeps the wound hydrated and contaminant free which in turn facilitates healing. (For detailed mode of action: please contact Vitrobio)
Product Presentation: 30ml sprays
Directions: Topical application, 3-4 sprays – 5-6 times per day.
Regulatory Status: Due to the mechanical topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structure, Hydrafilm is classified as a Class I Medical Device in Europe.
Contraindications: Check the product composition and do not use if you are sensitive or allergic to any of the ingredients (honey may contain traces of pollen).
Side Effects: In certain cases, a slight local irritation may be observed after application but will disappear after a few minutes. If you observe any type of allergic reaction after product application (ex: swelling, strong persistent irritation/burning sensation), cease using the product, flush your mouth thoroughly with fresh water, and consult a medical professional if necessary. If you notice any serious incidents due to the use of this product, please notify immediately the manufacturer/distributor and national competent authorities.
Clinical Efficacy:
Type of study: 4-week on mucositis patients against standard treatment. Patient demography: Total 69 (53M & 16F) – 48 in test product & 21. Placebo commonly used treatment group. Parameters: Oral hydration, mucositis, pain, burning sensation, development of new ulcers, capacity of eating solid food. Observations: 20-30 min, Days 1, 2, 3, 4, 7, 14, 21 & 28.
Results: (1) Instant hydration (2) Increased surface humidity v/s controls on days 1, 2, 3, 4, 5, 6, 7, 14, & 28 by 55%, 46%, 48%, 30%, 40%, 45%, 52%, 66%, & 60%.
Hydration lasting >4h. No side effects. Excellent patient & investigator’s satisfaction.
