an innovative wound dressing for radiation dermatitis...an innovative wound dressing for radiation...

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An Innovative Wound Dressing for Radiation Dermatitis StrataXRT ® is a film-forming wound dressing that dries into a thin, flexible and protective layer that is bacteriostatic, gas permeable, waterproof and inert. Radiation dermatitis is an acute skin reaction affecting approximately 95% of patients receiving radiation therapy to the breast, groins or perineum 1 . It generally ranges from erythema to dry or even moist desquamation and can be a source of significant pain, discomfort and psychological distress 2,3 . StrataXRT • StrataXRT is a proprietary film-forming wound dressing specifically designed for radiation dermatitis and dedicated to the management of its clinical signs, such as dry and moist desquamation. Does not cause bolus effect 6 Film-forming, full-contact and flexible Can be applied from day one of radiation therapy Faster re-epithelialization 7 Protective, inert and bacteriostatic • In contrast to StrataXRT, common moisturizers have shown no clinical efficacy 4,5 . They can even cause pain and discomfort when rubbed into the skin. The unique formula of StrataXRT spreads very easily and does not need to be rubbed in. It also requires a very small amount of product to create a thin protective layer to manage the side effects of radiation dermatitis.

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Page 1: An Innovative Wound Dressing for Radiation Dermatitis...An Innovative Wound Dressing for Radiation Dermatitis StrataXRT® is a film-forming wound dressing that dries into a thin, flexible

An Innovative Wound Dressing for Radiation DermatitisStrataXRT® is a film-forming wound dressing that dries into a thin, flexible and protective layer that is bacteriostatic, gas permeable, waterproof and inert. Radiation dermatitis is an acute skin reaction affecting approximately 95% of patients receiving radiation therapy to the breast, groins or perineum1. It generally ranges from erythema to dry or even moist desquamation and can be a source of significant pain, discomfort and psychological distress2,3.

StrataXRT

• StrataXRT is a proprietary film-forming wound dressing specifically designed for radiation dermatitis and dedicated to the management of its clinical signs, such as dry and moist desquamation.

Does not cause bolus effect6

Film-forming, full-contact and

flexible

Can be applied from day one of radiation therapy

Faster re-epithelialization7

Protective, inert and bacteriostatic

• In contrast to StrataXRT, common moisturizers have shownno clinical efficacy4,5. They can even cause pain and discomfort when rubbed into the skin. The unique formula of StrataXRT spreads very easily and does not need to be rubbed in. It also requires a very small amount of product to create a thin protective layer to manage the side effects of radiation dermatitis.

Page 2: An Innovative Wound Dressing for Radiation Dermatitis...An Innovative Wound Dressing for Radiation Dermatitis StrataXRT® is a film-forming wound dressing that dries into a thin, flexible

How much is required? StrataXRT 0.35oz (10 g) contains enough gel for over 1 week of treatment during a standard fractionation plan* applying the gel twice per day.

StrataXRT 0.70 oz (20 g) contains enough gel for over 2 weeks of treatment during a standard fractionation plan* applying the gel twice per day.

StrataXRT 1.75 oz (50 g) contains enough gel for over 5 weeks of treatment during a standard fractionation plan* applying the gel twice per day.

Case Study8 Korea, 2015 Yonsei University Health System, Severance Hospital, Korea

References: 1. Porock, KristJanson. Eur J Cancer Care (Engl). 1999;8(3):143-1532. Kedge E. Radiography. 2009;15(3):247-2573. Wells M et al. Radiation skin reactions. In: Faithfull S et al.

Supportive care in radiotherapy. London: Elsevier; 2003. p. 135–1594. McQuestion. Seminars in Oncology nursing 2011;27(2):e1-e17 5. Data on file, Stratpharma AG, Basel, Switzerland, 20186. Data on file, Stratpharma AG, Basel, Switzerland, 20177. Losi P et al. J Mater Sci Mater Med. 2012;23(9):2235–438. Data on file, Stratpharma AG, Basel Switzerland, 2015

Duration of treatment StrataXRT® is recommended to be applied from the first day of radiation therapy. StrataXRT should be applied for a minimum of 60–90 days (24 hours a day/7 days a week/twice daily), or until no further improvement is seen.

Patient showing a RTOG 3 radiation dermatitis with moderate edema and a confluent moist desquamation.

Patient applied StrataXRT during ongoing radiation therapy. After 7 days of topical treatment, the moist desquamation and edema resolved and the skin pigmentation improved.

Once dry, can be covered by sunscreen or cosmetics

Caution: For external use only • StrataXRT should not be placed in contact with the eyes • StrataXRT should not be applied over topical medic ations 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 • Should your radiation dermatitis show signs of infection or failure to heal after 30 days of initial product application, consult your physician • If irritation occurs, discontinue use and consult your physician • Not suitable for highly exudative wounds, tunneling wounds or 3rd degree burns • 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

2x Apply twice daily

5min Dries in

5 minutes

For best result, leave in constant contact with the skin

CV-U

S-00

2-1-

0318

Manufactured by: Stratpharma AG, Aeschenvorstadt 57, CH-4051 Basel, Switzerland

Class I Medical DeviceFDA Listed

COPYRIGHT © 2018. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. ALL OTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2018P1375US REV. A

Global Sales Office1401 8th Street SE, USAOrange City, IA 51041800.842.8688 | +1 [email protected] | www.CivcoRT.com

* Standard fractionation is considered to be 5 days per week. 2 weeks post radiation are expected for toxicity peak and 2 weeks more for recovery of the skin. The standard therapy time can therefore extend up to 2 weeks.

Ingredients: Polydimethylsiloxanes, siloxanes, alkylmethyl silicones. Sterile until opened.

Patient showing a severe RTOG 2.5 radiation dermatitis with a marked edema with superficial ulceration and a confluent moist desquamation.

Patient applied StrataXRT during ongoing radiation therapy. After 3 days of topical treatment there is no longer a sign of patchy moist desquamation. Patient shows a decrease of the edema but still a persisting depigmentation of the skin.

CIVCO Order Number STRXRT10

CIVCO Order Number STRXRT20

CIVCO Order Number STRXRT50