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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.
