Polydimethylsiloxanes, siloxanes, alkylmethyl silicones.
StrataXRT is a semi-occlusive, self-drying and transparent gel. (See Table 1.)
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Specific Regulations Outline:
Medicinal Products: The components of StrataXRT do not incorporate or administer medicinal products.
Human Blood Derivatives: The components of StrataXRT do not incorporate any human blood derivatives.
Animal Tissues: The components of StrataXRT are not manufactured utilizing animal tissues.
Software: The components of StrataXRT do not incorporate any software.
Personal Protective Equipment and Machineries: StrataXRT do not fall under the definition of machinery in directive 2006/42/EC or the personal protective equipment directive 89/686/EEC.
In accordance with ISO 10993-1:2009, StrataXRT is categorized as surface device, non-invasive medical devices, that are in contact with breached or compromised surface for permanent exposure. Please see SPA-TF-SX-302 Biocompatibility.
The Biocompatibility reports outlines details concerning biocompatibility data: (See Table 2.)
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Based upon the long-term clinical history and results of biocompatibility testing in accordance with the applicable parts of ISO 10993, StrataXRT is considered to be biocompatible with respect to the indication.
StrataXRT is sterile until opened.
A full contact flexible wound dressing for the prevention and treatment of radiation dermatitis.
When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion.
StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns.
StrataXRT dries to form a thin, flexible wound dressing which hydrates and protects affected areas.
StrataXRT has no measurable pH value so does not affect the fragile acid mantle of the skin.
StrataXRT helps to promote a moist wound healing environment for widespread superficial wounds and burns.
StrataXRT is a self-drying, non-sticky, transparent, gel formulation that lightly bonds to the most superficial damaged skin layer.
StrataXRT gel is bacteriostatic and inert.
This moist wound healing environment promotes faster re-epithelialization and significantly reduces the skin's acute inflammatory response seen with both dry and wet desquamation from radiation dosing and first and second degree burns.
In dry desquamation, StrataXRT protects the fragile epidermis and maintains the skin's integrity, preventing the outmost layers from excessive sloughing.
In moist desquamation, StrataXRT protects the dermal stroma from long-term deterioration whilst optimizing the environment for the healing process and reducing the risk of infection.
StrataXRT is ideal for large surface areas and contoured skin like the breasts, face, back and pelvic area, as well as joints and hairy areas without the need for shaving.
Clinical Evidence: The Clinical Evaluation was performed according to MEDDEV.2.7.1: "Guidelines on Medical Devices, Evaluation of Clinical Date: A Guide For Manufacturers and Notified Bodies."
The probable risks identified during the risk management are acceptable when weighed against the intended benefits to the patient.
The clinical evidence demonstrates that StrataXRT is conforming to the essential requirement for the CE Marking. For further details please refer to the Clinical Evaluation section SPA-TF-SX-306 Clinical Evaluation.
StrataXRT is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin.
For more severe inflammatory changes, StrataXRT reduces pain, redness, heat sensation and helps soothe the exposed skin areas.
StrataXRT was developed for use on all types of radiation dermatitis, toxic and compromised skin, superficial wounds and burns, including those resulting from: Radiation therapy, First and second degree burns.
StrataXRT may be applied to superficial wounds, burns and areas where skin integrity has been compromised.
StrataXRT may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains no alcohols, parabens or fragrances and is transparent and odorless. StrataXRT can be used with or without a secondary protective dressing. StrataXRT is suitable for children and people with sensitive skin. StrataXRT is intended for single patient use.
On first use 20 g tubes remove the cap, cut the nozzle tip of the tube and close with the cap after use. On 50 g tubes remove the cap, then the protective seal and close with the cap after use.
Ensure that the affected skin superficial wound is clean and dry.
Gently pat dry as much excess exudate or wound fluid from the area as possible prior to gel application.
Apply a very thin layer of StrataXRT directly to the affected area and allow the gel to dry.
StrataXRT should be applied once or twice daily to affected areas or as advised by the physician.
Once dry, StrataXRT may be covered by sunscreen, cosmetics and clothing.
For best results StrataXRT should be maintained in continuous contact with the skin (24 hours a day/ 7 days a week).
When applied correctly to exposed areas, StrataXRT should be dry in 5-6 minutes. If it takes longer to dry the patient has probably applied too much. Gently remove the excess with a clean tissue or gauze and allow the drying process to continue.
Recommended duration of treatment: StrataXRT is recommended as prophylaxis following the initial radiation dose and should continue to be applied for a minimum of 60-90 days (24 hours a day/7 days a week) post radiation therapy, or until no further improvement is seen. For chronic radiation dermatitis, continued use is recommended until no further improvement is seen.
For external use only.
StrataXRT should not be placed in contact with the eyes.
StrataXRT should not be applied over topical medications unless advised by the physician.
StrataXRT may stain clothing if not completely dry. If staining occurs, dry cleaning should be able to remove it without damaging the fabric.
For correct storage please reclose the tube tightly with the cap.
Should the radiation dermatitis show signs of infection or failure to heal after 30 days of initial product application, consult a physician.
If irritation occurs, discontinue use and consult a physician.
Not suitable for highly exudative wounds, tunnelling wounds or 3rd degree burns.
Do not use if the tube is damaged.
Shelf-Life: 5 years from the date of manufacture.
The patient information leaflet for StrataXRT provides information about relevant used, general instructions, warnings, and precautions as well as manufacturer information. See Patient Information Leaflet for StrataXRT.
D02AA - Silicone products ; Used as skin emollients and protectants.
Topical gel 20 g (white, no odour) x 1's.