Novel, flexible wound dressing specifically developed for the management of radiation dermatitis
What is StrataXRT?
StrataXRT is indicated for use on all types of radiation dermatitis, toxic and compromised skin and superficial wounds resulting from radiation therapy. StrataXRT is intended to be used under the direction of healthcare practitioners in the management of radiation dermatitis. Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Film-forming, full contact, flexible wound dressing
StrataXRT is a flexible, full contact wound dressing that forms a thin film that ensures constant contact with the skin.
From day one
StrataXRT can be applied from day one of radiation therapy.
No bolus effect
StrataXRT does not cause a bolus effect.
Faster wound healing
StrataXRT promotes a moist wound healing enviroment leading to faster re-epithelialization.
StrataXRT provides symptomatic relief from itching, burning sensation and discomfort. It also reduces redness and swelling.
StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates compromised skin areas and superficial wounds.
StrataXRT is bacteriostatic, it protects the skin from irritants and microbial invasion while reducing the risk of contact dermatitis.
For different areas
StrataXRT is suitable for large surface areas and contoured skin like the breats, face, back and pelvic area, as well as joints and hairy areas without the need for shaving.
How does StrataXRT work?
StrataXRT dries to form a thin, flexible, protective layer that is gas permeable and waterproof. This helps to promote a moist wound healing environment because it minimizes the Trans Epidermal Water Loss (TEWL) of the skin. The StrataXRT film lightly bonds to the most superficial damaged skin layer and protects compromised skin areas and superficial wounds.
This moist environment will lead to rapid healing and faster skin recovery post radiation therapy. It will also reduce the acute inflammatory response, and relieve dry, itching, flaking, peeling and irritated skin – the common side effects of radiation therapy.
Who can use StrataXRT?
StrataXRT is intended to be used under the direction of a healthcare practitioner in the management of radiation dermatitis. StrataXRT is indicated for use on all types of radiation dermatitis, toxic and compromised skin and superficial wounds resulting from radiation therapy. StrataXRT is suitable for children or people with sensitive skin.
StrataXRT is transparent and odorless. It does not contain alcohol, fragrances or parabens.
StrataXRT is non-reactive with no measurable pH.
StrataXRT is convenient and easy to use at home.
StrataXRT can be used in combination with other absorbent dressings.
StrataXRT is sterile until opened and bacteriostatic.
How to open a StrataXRT tube?
On the first use of 1.75 oz (50g) tube remove the cap, then the protective seal and close with the cap after use.
How to use StrataXRT?
StrataXRT is recommended to be used from the very first dose of radiation therapy.
For best results, StrataXRT should maintain in continuous contact with the skin (24 hours a day/ 7 days a week).
Directions for use
Step 1: Prepare your skin
Ensure that the affected skin or superficial wound is clean. Gently pat dry as much excess exudate or wound fluid from the area as possible prior to the gel application.
Step 2: Apply StrataXRT
Apply a very thin layer of StrataXRT directly onto the affected area.
Step 3: Allow the gel to dry
When applied correctly, StrataXRT should be dry in 5–6 minutes.
If it takes longer to dry, you have probably applied too much. Gently remove any excess gel with a clean tissue, gauze or paper towel and allow the drying process to continue.
Step 4: You are ready to go!
Once dry, StrataXRT can be covered with clothes, sunscreen or cosmetics.
StrataXRT should be applied once or twice daily to the affected areas or as required to maintain contact with the affected surface.
StrataXRT may be re-applied more often to ensure constant contact with the skin, or to reduce symptoms.
Washing will likely remove StrataXRT. Re-apply StrataXRT after each wash.
Areas with higher hygienic necessities (groin, perineum, anal) – StrataXRT should be applied after each urination and bowel movement, on dry and clean skin.
StrataXRT does not need to be removed prior to radiation therapy.
StrataXRT can be used with or without secondary protective dressing.
StrataXRT does not need to be rubbed in or massaged, as it does not penetrate below the level of stratum corneum and will not enhance its effect.
StrataXRT can be applied directly to the skin, using the finger, Q-tip etc.
Removing from your skin
The excess of StrataXRT on your hands can be easily removed by washing them with liquid soap and warm water. Repeat if necessary.
Removing from clothes
StrataXRT may stain clothing if not completely dry. If staining occurs, dry cleaning should be able to remove it without damaging the fabric.
Tips for StrataXRT usage
StrataXRT may be kept in the refrigerator to relieve the burn sensation that might occur following radiation therapy sessions.
Recommended duration of treatment
StrataXRT is recommended to be used following the initial radiation dose and should be applied continuously 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.
Dosage and administration
StrataXRT 1.75 oz (50g) is enough to treat an area of 6×12inch (15×30 cm) twice per day for 30 days.
StrataXRT gel is a unique formulation that requires substantially less product per application than typical creams or gels.
Make sure your clothing covers the treated area when you are outside.
Wear loose clothing.
Choose clothes and bed sheets made of soft materials.
Avoid direct sunlight. Sunscreen should be used for maximum protection from sunlight.
Use non-perfumed, mild soap and toiletries.
Shower or bath with warm water and not with hot water.
Gently pat your skin dry after taking a shower or bath.
Avoid swimming in chlorinated water as it can have a drying effect on the skin.
Do not rub off the marks your radiation therapist made on your skin. They show where to place the radiation.
Do not put anything that is very hot or cold on the radiated area.
Use an electric razor if your doctor or nurse say you can shave.
Do not “wet-shave” or use hair removal products.
StrataXRT and other products
Moisturizers, lotions, burn creams etc. are not required.
StrataXRT can be re-applied more often to avoid dry and tight skin feeling, as StrataXRT prevents the water evaporation through the damaged skin that may cause this feeling. Alternatively, a moisturizer can be applied after StrataXRT dries to maintain the first contact of StrataXRT with the skin.
StrataXRT reduces the need for corticosteroids.
StrataXRT reduces skin’s acute inflammatory response without side effects of corticosteroids.
StrataXRT reduces the need for antibiotics.
StrataXRT is bacteriostatic and prevents microbial and bacterial invasion without the risk of contact dermatitis.
Due to StrataXRT‘s semi-permeable nature:
- StrataXRT may enhance the effect of an active ingredient if StrataXRT is applied over the active ingredient.
- StrataXRT may prevent or reduce absorption of active ingredients if they are applied over StrataXRT.
StrataXRT will not absorb exudate. In moist desqumation, StrataXRT should be used in combination with absorbent dressings. StrataXRT should be the first layer of contact with the skin. StrataXRT does not need to dry before applying the secondary dressing.
Additional prescribing information
Therapeutic group: Wound dressing for the management of radiation dermatitis.
Pharmaceutical form: Occlusive, non-resorbable, self-drying and transparent gel.
Description: 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 helps to promote a moist wound healing environment. This moist wound healing environment promotes faster re-epithelialization* and reduces the skin’s acute inflammatory response seen with both dry and moist desquamation.
Warnings: 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 your 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. If irritation occurs, discontinue use and consult your physician. Keep out of the reach of children. Do not use after the expiration (EXP) date printed on the tube. The expiration (EXP) date does not change once the tube has been opened. Do not use if the tube is damaged.
Contraindication: Do not administer to patients with known hypersensitivity to the ingredients of this product.
Side effects: At the time of producing this material, no adverse effects have been reported with the use of StrataXRT.
Drug interactions: None known.
Use in specific populations: No specific population restrictions, StrataXRT is suitable for children and people with sensitive skin.
Storage: Store at room temperature, out of direct sunlight.
*Losi P et al. J Mater Sci Mater Med. 2012;23(9):2235–43