What is StrataCTX?
StrataCTX is indicated for use on all types of wounds, toxic and compromised skin including: cutaneous reactions, pruritic, itchy skin, xerotic, dry skin, desquamation, fissures of skin and nail folds, blisters, Medical Adhesive-Related Skin Injuries (MARSI), erythema, infusion reactions, rashes, including: maculopapular rash, hand-foot syndrome, GVHD, acneiform reaction, peri – and appendageal (hair follicles, sweat glands). StrataCTX is intended to be used under the direction of healthcare practitioners in the management of cutaneous reactions. Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.
How does StrataCTX work?
When used as directed StrataCTX dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical irritants and microbial invasion. StrataCTX is a self-drying, non-sticky gel formulation that lightly bonds to the most superficial damaged skin layer. StrataCTX helps to promote a moist healing environment for wounds or compromised skin. This moist wound healing environment promotes faster re-epithelialization and significantly reduces the skin’s acute inflammatory response.
Who can use StrataCTX ?
StrataCTX is intended to be used under the direction of healthcare practitioners in the management of cutaneous reactions. StrataCTX is indicated for children and people with sensitive skin. StrataCTX is intended for single patient use. It is ideal for large surface areas and contoured skin (e.g. head, face, hands and feet) as well as joints. It can also be used on hairy areas without the need to shave them.
- StrataCTX is transparent allowing users to monitor therapy progress without having to remove the dressing.
- StrataCTX is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. In cases of more severe inflammatory changes, StrataCTX reduces pain, redness and heat sensation.
- StrataCTX was developed for use on all types of wounds, toxic and compromised skin.
- StrataCTX can be used with or without a secondary protective dressing.
How to open a StrataCTX tube
How to use StrataCTX
StrataCTX is recommended to be applied following the first day of treatment, or the first signs or symptoms on the skin. It should be applied until the skin condition is resolved or until no further improvement is seen.
Directions for use
Ensure that the affected superficial area is clean and dry.
Apply a very thin layer of StrataCTX directly to the affected area and allow the gel to dry.
When applied correctly, StrataCTX 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.
Once dry, StrataCTX can be covered with clothes, sunscreen or cosmetics.
- StrataCTX may be re-applied more often to ensure constant contact with the skin, or to reduce symptoms.
- Washing will likely remove StrataCTX. Re-apply StrataCTX after each wash.
- Areas with higher hygienic necessities (groin, perineum, anal). StrataCTX should be applied after each urination and bowel movement, on dry and clean skin.
- StrataCTX 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.
- StrataCTX can be applied directly to the skin, using the finger, Q-tip etc.
Any excess of StrataCTX on your hands can be easily removed by washing them with liquid soap and warm water. Repeat if necessary.
StrataCTX may stain clothing if not completely dry. If staining occurs, dry cleaning should be able to remove it without damaging the fabric.
Tips for StrataCTX usage
- StrataCTX may be stored in the refrigerator prior to application for faster relief of symptoms.
- StrataCTX can be used with or without a secondary protective dressing.
Recommended duration of treatment
StrataCTX is recommended as a treatment following the first signs or symptoms. It should be applied until the skin condition is resolved or until no further improvement is seen.
Dosage and administration
twice per day for 30 days.
StrataCTX gel is an advanced 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 the 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
- Use an electric razor if your doctor or nurse say you can shave
- Do not “wet-shave” or use hair removal products
StrataCTX and other products
Moisturizers, lotions etc. are not required. StrataCTX can be re-applied more often to avoid dry and tight skin feeling, as StrataCTX prevents the water evaporation through the damaged skin that may cause this feeling. Alternatively, a moisturizer can be applied after StrataCTX dries to maintain the first contact of StrataCTX with the skin.
StrataCTX reduces the need for corticosteroids or antibiotics. StrataCTX reduces skin’s acute inflammatory response without side effects of corticosteroids or antibiotics. StrataCTX is bacteriostatic and prevents microbial and bacterial invasion without the risk of contact dermatitis.
Due to StrataCTX‘s semi-permeable nature:
• StrataCTX may enhance the effect of an active ingredient if StrataCTX is applied over the active ingredient.
• StrataCTX may prevent or reduce adsorption of active ingredients if that are applied over StrataCTX.
Additional prescribing information
Therapeutic group: Wound dressing for the management of cutaneous reactions.
Pharmaceutical form: Occlusive, non-resorbable, self-drying and transparent gel.
Description: When used as directed StrataCTX 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. StrataCTX helps to promote a moist healing environment. This moist wound healing environment promotes faster re-epithelialization* and reduces the skin’s acute inflammatory response.
Warnings: For external use only. StrataCTX should not be placed in contact with the eyes. StrataCTX should not be applied over topical medications unless advised by your physician. StrataCTX 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.
Contraindications: 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 StrataCTX.
Drug interactions: None known.
Use in specific populations: No specific population restrictions, StrataCTX is suitable for children and people with sensitive skin.
Storage: Store at room temperature, out of direct sunlight.
StrataCTX Information Booklet for Prescribers
StrataCTX Patient Brochure