strataxrt - civcort.com · treatment will undergo radiation therapy at some stage of their illness....

StrataXRT®

for the management of radiation induced skin reactions

2 Web www.CivcoRT.com Email [email protected]

· Up to 50–60% of patients receiving cancer treatment will undergo radiation therapy at some stage of their illness.1,4,5

Radiation dermatitis is an acute skin reaction affecting approximately 95% of patients who receive radiation therapy to the breast, groins or perineum.1,2,3 It generally ranges from erythema to dry or even moist desquamation and can be a source of significant pain, discomfort and psychological distress. In particular, moist desquamation poses the risk of infection and can result in treatment breaks which impair patient outcomes.3

Radiation Dermatitis – The Unwelcome Consequence of a Life-Saving Therapy

How do the current therapies rate?Studies assessing lotions, creams, or emulsions (aloe vera, hyaluronic acid, corticosteroids, sucralfate) either showed no benefit in managing radiation dermatitis or provided conflicting evidence.7,8,9

It is essential that any skin damage is minimized by ensuring that interventions are based upon best practice, and supported by evidence-based guidelines.2

· The introduction of modern mega-voltage treatmentmachines with skin-sparing capabilities haveimproved but not eliminated skin toxicities.6

Consensus goals of care for skin reactions during radiation therapy8, 10, 11 StrataXRT scores

Initial maintenance of skin integrity

Reduced potential of further exacerbation of skin reactions

Minimized water loss and optimized skin hydration by means of topical agents

Promotion of comfort and compliance

Reduction of pain and pruritus without causing a bolus effect

Control of bleeding, odor and excessive exudate (in combination with secondary dressing)

Provides ideal environment for rapid healing and re-epithelialization

Promotion of moist wound healing environment where skin is broken

Protection from trauma & friction

Protection of infection

3 Web www.CivcoRT.com Email [email protected] Global Sales 800.842.8688 | +1 712.737.8688

The RTOG Scale for Radiation Dermatitis

Photos from several patients.Other scales of measurement include RISRAS and CTCAE. The key measurement point on this RTOG scale is level 2.5 (2b), which denotes the first level of the appearance of moist desqumation.

The RTOG scale (Radiation Therapy Oncology Group) provides a standardized description of radiation induced side effects. Interventions are usually matched to the skin’s reaction based on its assessment and the RTOG score.

Progression of symptoms and skin changes according to the RTOG scale during radiation therapy*

RTOG Scale Score

Observation: External Signs

Observation: Cellular Level Clinical Assessment Treatment Goals

0 No visible change to skin Maintain soft, supple, clean, odor free and intact skin.

1 Redness. InflammationMild tightness/itch

Maintain soft, supple, clean odor free, intact skin, reduce irritation and promote comfort.

2Sensitive skin with bright redness With/without dry desquamationTightness/itch/sore

Promote skin hydration, comfort and maintain skin integrity. Reduce itch, pain, soreness and discomfort.

2.5 Patchy moist desquamationModerate oozing

Reduce risk of complications of further trauma and infection. Reduce pain, soreness and discomfort.13

3 Confluent moist desquamationPitting oozing

Reduce the risk of infection, minimize pain and trauma of the skin.

4 Ulceration, bleeding, necrosis

Debride the wound. Control associated blee ding and oozing (exudate), minimize effects of wound infection.

Images (RTOG 0–3) courtesy of The Princess Royal Radiotherapy Review Team, St James’s Institute of Oncology, The Leeds Teaching Hospitals NHS Trust. Taken from the publication “Managing Radiotherapy Induced Skin Reactions, a Toolkit for Healthcare Professionals”.

* Curve generated from the general progression of radiation dermatitis for patients undergoing radiation therapy. Levels of reaction differ significantly between patients and treatments. If untreated however the level of reaction generally follow the shape of this curve.4


Can be applied from day one of radiation therapy

Faster re-epitheliali-zation12 promoted by a moist wound healing environment

Does not cause bolus effect14

Lightly bonds to the most superficial damaged layer of the skin

Sterile, biologically inert and bacteriostatic

Fast drying For best resut, leave in constant contact with the skin

Full contact flexible wound dressing

StrataXRT helps to reduce Trans Epidermal Water Loss (TEWL) while promoting a moist wound healing environment, leading to:· Faster re-epithelialization12 of the skin post-

therapy· Relief of low grade cutaneous changes such as

dry, itching, flaking, peeling and irritated skin· Reduced pain, redness and heat, while

helping to soothe exposed areas in moresevere inflammatory changes

StrataXRT protects the fragile epidermis during dry desquamation leading to:· Preservation of the skin integrity· Prevention of excessive sloughing

of the outmost layers

StrataXRT protects the dermal stroma from long-term deterioration during moist desquamation leading to:

· Optimization of the environmentfor the reparative process

· Reducing the risk of infection

Management of Radiation Dermatitis with StrataXRT

StrataXRT film-forming gel dries as a thin, flexible and protective layer that is gas permeable, waterproof, inert and has no measurable pH value.

Why is StrataXRT an Innovative Wound Dressing?

Immature cell

Stratum corneum

Application of StrataXRT

Dead cell

Irradiated site


apy: RTOG score of 2.5 ± 0.trataXRT redu

A 28-patient multicenter study performed in Spain (2015). Starting of ther 5. All patients were treated with StrataXRT while undergoing radiation therapy.13 S ces the severity of radiation induced skin reactions and significantly decreases the RISRAS score, even if patients are undergoing radiation therapy treatment.

The Springfield Radiation Oncology Center in Australia conducted measurements on increasing electron beam energy levels to verify the bolus effect of a clinical dose of StrataXRT.14 This study showed that StrataXRT does not cause a bolus effect since the energy of the beam is not affected by the product.

MethodFigure 1 shows the experimental setup of the dosimetric measurement. Three readings were made for each of the energy levels (6, 9, 12, 16 MeV). The first time without the application of StrataXRT, the second time with the application of StrataXRT.

Clinical Study

StrataXRT Does Not Cause Bolus Effect

During the application period, StrataXRT showed a decrease of pain by 20.48%*, of the itching by 22.22%*, of the burningsensation by 24.69%*, the erythema by 21.13%* and an improvement of the hydration by 26%*. (*p-value <0.05)

Measurement of Clinical Signs and Symptoms During Radiation Therapy Treatment

Eval

uatio

n sc

ale N

umber of G

raysCumulative radiation dose4.0

3.53.02.52.01.51.00.50.0

1.00.90.80.70.60.50.40.30.20.10.0

16.0

15.0

14.0

13.0

12.0

16.160

55

50

45

40

70

60

50

40

30

20

10

01Day

30 31 32 33 34

0 1 2 3 4 5 6 7 8 9 10 11 12

35 36 37 38 39 40Day

3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39

Pain

Itching

Burning sensation

Erythema

Hydration

Cumulative radiation dose


First day of radiation therapy

Evolution of Risras Score During Radiation Therapy Treatment and When Applying StrataXRT

RISRAS score(Radiation-induced Skin Reactions Assessment Scale)

Eval

uatio

n sc

ale

REDUCTION OF 16.85%

Num

ber of Grays

Depth in White Water (mm)

TMR

Valu

e

18 MV beam6 MV beamPhantom + physical dressing

Phantom

Impact on Radiation Beam

Skincare Overall Costs During Radiation Therapy Treatment

ThermoplasticMask

0.5mm

Topical Productwith Silicone

13.4

14

12

10

8

6

4

2

06 MeV

with StrataXRT without StrataXRT

Measurements at Different Energy Levelswith and without StrataXRT Application

Nan

oclo

ulom

bs

Physicaldressings

Nursingtime

Moisturizingcream

Common treatments

Cost

StrataXRT

StrataXRT

Burncream

Extra nursing time needed to cut and adapt dressings StrataXRT

No nursing time Self-applicable by patient Developed for radiation dermatitis Proven clinical efficacy

Need to be carefully applied and adjusted to avoid bolus effect

Not developed forradiation dermatitis

No proven clinical efficacy

9 MeV 12 MeV 16 MeV

Roos ChamberSolid WaterStrataXRT

Electron Beam(6/9/12/16 MeV)

SSD

100c

m

0% 0% -0.1%-0.1%

10×10cmField Size



Eval

uatio

n sc

ale N

umber of G

rays

Cumulative radiation dose4.03.53.02.52.01.51.00.50.0

1.00.90.80.70.60.50.40.30.20.10.0

16.0

15.0

14.0

13.0

12.0

16.160

55

50

45

40

70

60

50

40

30

20

10

01Day

30 31 32 33 34

0 1 2 3 4 5 6 7 8 9 10 11 12

35 36 37 38 39 40Day

3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39

Pain

Itching

Burning sensation

Erythema

Hydration






Eval

uatio

n sc

ale

REDUCTION OF 16.85%

Num

ber of Grays


TMR

Valu

e


Phantom



ThermoplasticMask

0.5mm


13.4

14

12

10

8

6

4

2

06 MeV



Nan

oclo

ulom

bs

Physicaldressings

Nursingtime

Moisturizingcream

Common treatments

Cost

StrataXRT

StrataXRT

Burncream






9 MeV 12 MeV 16 MeV



SSD

100c

m

0% 0% -0.1%-0.1%

10×10cmField Size



Eval

uatio

n sc

ale N

umber of G

rays


1.00.90.80.70.60.50.40.30.20.10.0

16.0

15.0

14.0

13.0

12.0

16.160

55

50

45

40

70

60

50

40

30

20

10

01Day

30 31 32 33 34

0 1 2 3 4 5 6 7 8 9 10 11 12

35 36 37 38 39 40Day

3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39

Pain

Itching

Burning sensation

Erythema

Hydration






Eval

uatio

n sc

ale

REDUCTION OF 16.85%

Num

ber of Grays


TMR

Valu

e


Phantom



ThermoplasticMask

0.5mm


13.4

14

12

10

8

6

4

2

06 MeV



Nan

oclo

ulom

bs

Physicaldressings

Nursingtime

Moisturizingcream

Common treatments

Cost

StrataXRT

StrataXRT

Burncream






9 MeV 12 MeV 16 MeV



SSD

100c

m

0% 0% -0.1%-0.1%

10×10cmField Size

Figure 1


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

A series of case studies was performed for treatment of radiation dermatitis at different RTOG stages of toxicity. Patients and nurses reported an overall improvement, reduced itching and pain symptoms. Patients positively evaluated the transparency of StrataXRT once it dried, while protecting the affected area.15

Head and Neck Cancer

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.

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.

Radiation Dermatitis Case Studies: All patients continued radiation therapy while applying StrataXRT


Radiation Dermatitis Case Studies: All patients continued radiation therapy while applying StrataXRT

Head and neck cancer

Case Study Spain, 2015Hospital Universitario de Fuenlabrada, Hospital Ruber Internacional, Madrid Spain

A series of case studies was performed on patients with a RTOG score of 2.5 ± 0.5. Patients and nurses reported an overall improvement, reduced itching and pain symptoms. Patients appreciated the ease of use as well as the comfort provided by StrataXRT.16

Patient applied StrataXRT during ongoing radiation therapy. After 19 days of topical treatment, a reduction of edema and erythema, and closure of the wound was observed.

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

Patient applied StrataXRT during ongoing radiation therapy. After 20 days of topical treatment there is no longer a sign of the erythema. The scar shows low inflammatory signs, while the surrounding skin area has persisting depigmentation.

Patient showing a severe RTOG 2 radiation dermatitis with a bright erythema and an inflammation of the scar. No signs of dry desquamation.

Calf muscle cancer

Comunidad de Madrid

Hospital Universitariode Fuenlabrada

Recommended duration of treatmentStrataXRT is recommended to be applied following the initial radiation dose and should continue to be used for a minimum of 60–90 days (24/7) post-radiation therapy, or until no further improvement is seen. For chronic radiation dermatitis, continued use is recommended until no further improvement is seen.Ingredients: Polydimethylsiloxanes, siloxanes, alkylmethyl siliconesCaution: 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. Should your radiation dermatitis show signs of infection or failure to heal, 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.STERILE UNTIL OPENED

Directions for use• Ensure that the affected skin or 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 the

affected areas or as advised by your 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 hrs/day).When applied correctly to the affected areas, StrataXRT should be dry in 5–6 minutes. If it takes longer to dry, you have probably applied too much. Gently remove the excess with a clean tissue or gauze and allow the drying process to continue. StrataXRT may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT can be used with or without a secondary protective dressing.

References:1 Porock D & Kristjanson L. Eur J Cancer Care. 1999;8:143–1532 Kedge E. Radiography 2009;15:247–2573 Wells M et al. Radiation skin reactions. In: Faithfull S et al.

Supportive care in radiotherapy. London: Elsevier; 2003. p. 135–159 4 Naylor W & Mallett J. Eur J Oncol Nurs. 2001;5(4):221–2335 López E, Nuñez MI, Guerrero MR et al. Breast Cancer Res Treat.

2002;73(2):127–1346 Hymes S et al. J Am Acad Dermatol. 2006;54(1):28–467 Bolderston et al. Supportive Care in Cancer 2006;14(8):802–8178 McQuestion. Seminars in Oncology nursing 2006;22(3):163–1739 Wickline. Oncology nursing forum 2004;31(2):237–24410 Bernier J. et al. Ann Oncol. 2008 Jan;19(1):142-911 Trueman E. The Princess Royal Radiotherapy Review Team. 201112 Losi P et al. J Mater Sci Mater Med. 2012;23(9):2235–4313 Data on file, Stratpharma AG, Basel, Switzerland, 201514 Data on file, Stratpharma AG, Basel, Switzerland, 201715 Data on file, Stratpharma AG, Basel, Switzerland, 201516 Data on file, Stratpharma AG, Basel, Switzerland, 2015

us.strataxrt.com

CV-U

S-00

1-2-

0318

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

Class I Medical DeviceFDA Listed

StrataXRT vs Common Treatment Regimen

How Much StrataXRT is RequiredStrataXRT gel is a unique formulation that requires substantially less product per application than typical moisturising creams or barrier ointments.

StrataXRT reduces the severity of radiation induced skin reactions, therefore minimizing the probabilities of not complying with the planned radiation therapy.

* Standard fractionation in head and neck cancer treatment is considered to be 6 weeks. 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.

StrataXRT 0.7 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.



Eval

uatio

n sc

ale N

umber of G

rays


1.00.90.80.70.60.50.40.30.20.10.0

16.0

15.0

14.0

13.0

12.0

16.160

55

50

45

40

70

60

50

40

30

20

10

01Day

30 31 32 33 34

0 1 2 3 4 5 6 7 8 9 10 11 12

35 36 37 38 39 40Day

3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39

Pain

Itching

Burning sensation

Erythema

Hydration






Eval

uatio

n sc

ale

REDUCTION OF 16.85%

Num

ber of Grays


TMR

Valu

e


Phantom



ThermoplasticMask

0.5mm


13.4

14

12

10

8

6

4

2

06 MeV



Nan

oclo

ulom

bs

Physicaldressings

Nursingtime

Moisturizingcream

Common treatments

Cost

StrataXRT

StrataXRT

Burncream




Not developed for radiation dermatitis


9 MeV 12 MeV 16 MeV



SSD

100c

m

0% 0% -0.1%-0.1%

10×10cmField Size

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

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. 2018P1367US REV. B

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

strataxrt - civcort.com · treatment will undergo radiation therapy at some stage of their illness....

Documents