Frequently Asked Questions

We are happy to answer all of your questions you have about Stratamed. Many questions are already covered in this FAQ collection. If you can not find the answer to your specific question, please feel free to contact our customer service.

 

General

What is Stratamed?

Stratamed is a full-contact flexible wound dressing which provides an optimal wound healing environment and abnormal scar prevention.

What is Stratamed made of?

Stratamed is a self-drying, non-sticky, transparent, gel formulation that lightly bonds to the most superficial damaged skin layer.

How does Stratamed work?

Faster re-epithelialization of the wound bed
Stratamed’s protective and hydrophobic silicone film has a semi-occlusive effect and therefore improves the tissue hydration of the injured skin. It allows a faster migration of keratinocytes across the wound bed and supports a more rapid re-epithelialization and effective healing. The faster re-epithelialization dramatically decreases the incidence of abnormal scarring and leads to a fast recovery.

Reduction of inflammatory response
Stratamed forms a flexible, protective sheet that is gas permeable but semi-occlusive, which weakly bonds to the injured skin and protects it from chemical and microbial invasion, but it does not penetrate into the epidermis or dermis. The polymers Stratamed contains have no measurable pH value, and therefore do not affect the protective acid mantle of the skin and do not react with the newly forming epithelial tissues. This leads to a reduction in the inflammatory response (redness/discoloration, burning sensation, itching, discomfort, pain, etc.), and effective healing of the wound and therefore enhances therapeutic results.

Abnormal scar prevention
After the re-epithelialization of a wound, the stratum corneum (dead skin layer) is immature and still allows abnormally high levels of Trans-Epidermal Water Loss (TEWL). Dehydration is signaled to keratinocytes, which then start to produce cytokines, which in epidermal-dermal signaling activate dermal fibroblasts to synthesize and release collagen. Excessive collagen production leads to abnormal scarring. At this wound healing stage, the Stratamed layer restores the barrier function of the stratum corneum, reduces TEWL and stops dehydration of the skin. Reduction of TEWL turns off stimulation of keratinocytes and the production of cytokines and thus normalizes the level of collagen production, resulting in a normal mature scar.

On what types of wounds is Stratamed effective?

Stratamed was developed for use on all types of superficial wounds, burns, skin tears and abrasions including those resulting from:

  • General and cosmetic surgery
  • Trauma
  • Burns
  • Radiation therapy
  • Bites
  • Grazes
  • Laser therapy, including tattoo removal
  • Chemical peels
  • Dermal abrasion
  • Cryotherapy
  • Acne and other diseases of the skin

What are the advantages of using Stratamed gel instead of Physical wound dressings?

There are delicate areas where it is very difficult or impossible to use physical dressings:

  • Areas with high mobility
  • Areas with high friction
  • Wet skin (mucosa), hindering adherence
  • Areas with higher hygienic requirements (like perineum)

Physical dressings (including silicone dressings) do not create a full contact surface as air bubbles form underneath. Delicate areas like the eyes, nostrils and lip contours remain exposed and subjected to irritation due to the adhesive tape. Stratamed is an advanced film forming wound dressing in the form of a self-drying silicone gel. Stratamed is flexible, adaptable, and creates a full contact surface.

Is Stratamed safe to use on children?

Yes. Stratamed is completely biocompatible, inert and is intended for the use for both, children and people with sensitive skin.

Are there any side effects associated with the use of Stratamed?

There have been no side effects observed with the proper use of Stratamed. The ingredients in Stratamed are completely compatible with human biology. However, if redness, pain or skin irritation should occur, discontinue treatment and consult your physician.

Does Stratamed have any odor associated with it?

No. Stratamed is odorless.

Is Stratamed an effective acne treatment?

No. Stratamed is not indicated for the use on active acne.

Is Stratamed safe to use during pregnancy?

Yes. Stratamed is safe to use during pregnancy for both mother and unborn child.

Are there any known allergies to Stratamed?

There are no known allergies to Stratamed, either remote/distant or on site. Stratamed is an inert biocompatible non-transdermal polymer. We have completed irritation, sensitivity and acute toxicity testing on Stratamed with no noted reactions.

Is Stratamed effective on all skin types?

Yes. Stratamed is effective on all types of skin, no matter what color or shade.

Will Stratamed damage my hair?

Stratamed will not damage your hair. It has no effect on your hair.

Where can I find further information about Stratamed, for example a patient leaflet or similar?

Please refer to the info center on our website, where we provide our latest information materials.

Does Stratamed have an expiry date? I can not find this information on my tube.

Stratamed has an expiry date of five years after manufacturing. This date is imprinted on every box (side flap) and tube (end seal) in the format year-month (e.g. EXP 2018-09 or 13-09).

Is there any sun protection in Stratamed?

No. However you can apply a sun protection or cosmetics on top of Stratamed, once it has completely dried.

 

How to use Stratamed

How is Stratamed to be used?

The usage of Stratamed does not require changes in any existing wound care protocol. It is a simple addition to your usual process – but with great effects. First ensure that the affected skin or wound is clean. Gently pat dry as much excess exudate or wound fluid from the wound as possible prior to the application of Stratamed. For best results Stratamed should be maintained in continuous contact with the skin (24 hours a day/7 days a week). When applied correctly to exposed areas, Stratamed 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.

On damaged or broken skin not requiring a secondary dressing:

  • Apply a very thin layer of Stratamed to the affected area and allow the gel to dry.
  • Stratamed should be applied once daily, or twice daily to exposed areas or as advised by your physician.
  • Once dry, Stratamed can be covered by sun screen, cosmetics, pressure garments or casts.

On damaged skin or wounds requiring a secondary dressing:

  • Apply a thin layer of Stratamed then cover with the secondary dressing. Drying is not necessary.
  • Stratamed should be reapplied when changing the dressing or checking wound progress, or as advised by your physician.

After applying Stratamed, the gel does not dry within the recommended time. What is the reason for this?

When applied correctly, Stratamed 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 tissue and allow the drying process to continue.

How do I know when Stratamed is completely dry?

When your Stratamed is dry to the touch, it is "completely" dry.

Can Stratamed be used in conjunction with other medications?

If an infection is present, have it treated prior to beginning your Stratamed treatment. Do not apply any other product underneath Stratamed. Applying medications on top of Stratamed will have no effect because, by design, it will not be able to pass through the Stratamed film.

Should I continue to apply Stratamed after 90 days?

If you are still progressing at 90 days, continue to apply Stratamed until you are no longer seeing an improvement.

When can I start to apply Stratamed after surgery?

You can start to apply Stratamed after suturing.

Would it be better to use surgical tape over Stratamed?

There is no need to use tape over Stratamed. If the wound is on an area of the body that may get bumped and scraped, cover it with a secondary dressing.

Can I use Stratamed while taking medication?

Yes. Stratamed does not enter the bloodstream. It simply forms a film over the wound’s surface.

Can Stratamed be used on eyelids?

Yes. Stratamed goes through an evaporation process during the drying phase which may cause the eyes to sting temporarily. This stinging will cause no harm.

What do I do if Stratamed gets into my eyes?

If Stratamed enters the eyes it will cause some stinging but will do no harm. Your eyes will flush themselves out over a short period of time. Eye drops may help alleviate the stinging.

Can Stratamed be used on the lips?

Yes. Stratamed can safely be used on the lips. Stratamed may need to be applied more frequently when used on the lips.

Is it possible to apply other treatments over Stratamed once it dries?

Yes. After Stratamed has dried any other treatments (cosmetics, sun screen) can be applied.

Are there any precautions?

  • Stratamed should not be applied over other skin treatments without the advice of your physician.
  • Stratamed may stain clothing if not completely dry.
  • Stratamed is for external use only.
  • If irritation occurs, discontinue use and consult your physician.
  • Keep Stratamed out of the reach of children.
  • Store below 25°C (77°F).
  • Do not use Stratamed after the expiration (EXP) date printed on the tube.

 

Healthcare Professionals

Can Stratamed or Strataderm be used as additional treatment for patients with scleroderma?

Strataderm and Stratamed are not indicated for scleroderma (for example psoriasis), they will not treat the underlying condition but will act as a thin flexible membrane which protects and hydrates these areas. There are no studies or experience of topical silicones being used to minimize the collagen fibers formed in this disease. Strataderm and Stratamed may have an effect if the over production of collagen fibers is a result of dermal signaling. However, in more pronounced cases it is unlikely that topical silicone will have an effect as it only acts on the surface of the skin and does not penetrate the most superficial layer.

Is Stratamed sterile?

Yes. Stratamed is sterile until opened. However, Stratamed is bacteriostatic, it hinders bacteria from reproducing, while not necessarily harming them otherwise, making it safe for use on open wounds or compromised skin.

What other differences persist between Strataderm and Stratamed?

Indications

The most important difference is, that Stratamed can be used on non-epithelialized wounds and on compromised skin in contrast to Strataderm, which is not approved for these indications.

Registration

An important distinction is the class of registration and the requirements for each classification. Stratamed is registered as a Class IIa device. The class difference necessarily means that Stratamed had been reviewed by a notified body (to obtain the CE mark in Class IIa) and that Stratpharma has supplied and had approved the full registration dossier which must contain much more detail and testing (e.g. toxicology, performance, risk analysis etc.). Strataderm is registered as a Class I device. Class I devices for use on closed skin do not have to use medical grade ingredients, they can use cosmetic grade materials. Medical grade materials are produced under GMP conditions, with very high standards for purity, quality and necessary additional regulations for toxicology. This important distinction means that physicians can safely use Stratamed on open wounds as it is supported and approved for this purpose. All other scar therapy silicone gels currently available on the market do not have this registration.

Formulation

The formulations of Stratamed and Strataderm are different even though they both contain all silicone components. The components are different because the “performance” of the gel must be different. Stratamed is specifically formulated to be applied to areas where the upper layers of skin are not present (i.e. stratum corneum, epidermis and parts of the dermis). This necessarily means that the contact surface and “task” of the gel is different. Stratamed can be used on open wounds while Strataderm can only be used on closed wounds whereas the specially formulated gel can be applied to skin that has a stratum corneum to ’bond’ to this layer and form a durable sheet.

Can Stratamed be used to treat psoriasis?

Stratamed is not indicated for psoriasis, however we have reports from some physicians that have tried it on psoriasis and it appears to provide symptomatic relief. Stratamed will not treat the underlying condition, however, it will act as a flexible wound dressing for these patients. It should be noted that if the physician is using Stratamed in combination with other treatments that they should be aware that the activity of any other topical medication given in combination will be influenced by Stratamed.

  • If Stratamed is applied over the other topical medication it will act as a semi-occlusive dressing and will potentially enhance the effect of the topical treatment underneath.
  • If Stratamed is applied first then another topical medication is applied over the Stratamed it will act as a barrier and will diminish or block the activity of the product being applied on top.

In our pipeline of products psoriasis is one of our targeted indications for future product development.

Can Stratamed be used on perineum wounds?

Yes. Stratamed can be used on wounds on the perineum in combination and as monotherapy. Stratamed is easy to use in this area as there is no need for shaving and it works on flexible and sensitive areas. For wounds associated with child birth Stratamed should be used until the area has healed.

Can Stratamed be used after plastic surgery on perineum?

Yes. Stratamed is ideal for this area following surgery.

Can Stratamed be used on burns?

Stratamed may be used on fresh 1st degree burns as it will protect and hydrate the affected areas. However with severe burns (2nd and 3rd degree) and in patients with risk of infection, Stratamed will not act against this infection. On superficial burns Stratamed will be effective and a good therapy option. For full thickness burns Stratamed is best used when these wounds are already in the granulating stage. This is when the infection risk has been reduced, there is no remaining necrotic tissue and the risk of forming hypertrophic scars is high. In these situations we would expect to see faster re-epithelialization with a better scarring outcome. (ie. prevention of severe hypertrophic scarring).

The activity of locally acting agents will be enhanced by Stratamed because of the semi-occlusive nature of the film formed. Stratamed will not react with these agents.

Can you use Stratamed on surgical wounds?

Yes, wound treatment protocols should stay the same. If the wound should be cleaned (that is if the surgeon would normally clean the wound) with an antiseptic preparation then this should be done prior to the application of Stratamed. There should be no reaction between the antiseptics and Stratamed, however the choice of antiseptic agents should depend more on the ability of Stratamed to stick to this material. An antiseptic solution (like Betadine) that dries on application would be easier for the Stratamed to adhere to. Stratamed should be applied just before the secondary standard protective wound dressing.

How do you use Stratamed in the first few days after a laser resurfacing when there are a lot of exudates and Stratamed may be washed away?

In heavily exudating wounds we recommend applying Stratamedmore frequently for the first 3-4 days while the wound is producing a large amount of fluid and detritus is being removed. After this initial phase, we recommend a once-daily application until the wound has healed. It is acceptable to apply Stratamed more often in the beginning of a treatment. Each time the wound is cleaned Stratamed should be reapplied. In any case, application of Stratamed is advised from the very beginning (i.e. after the cooling process or immediately after the procedure).

Does Stratamed prevent the blisters after skin burns?

Blisters are usually a direct result of the injury from heat exposure and are difficult to prevent. Stratamed will help protect the blister and the surrounding skin. Stratamed helps create an optimal wound healing environment for superficial burns and radiation dermatitis which leads to a faster recovery time and a reduced inflammatory response.

Do you need to clean the wound and remove residual gel before another application of Stratamed?

As a general rule, the wound care protocol should not be changed, normal wound cleaning procedures should continue. It is not necessary to remove the residual Stratamed but the wound must be clean and dry before the new application. The question is: Is the wound clean and dry? If yes, then new Stratamedshould be applied. If no, then the wound should be cleaned and dried before Stratamed application.

What happens to the gel on the wound, does it disappear?

It does not disappear but it does eventually wear off. Stratamed is not absorbed into the wound or the body. It forms a weak bond to the wound surface which allows for hydration and the migration through the ECM of fibroblasts etc. underneath the Stratamed layer.

Should you expect any sanitary problems of the wound after multiple applications?

The doctor should maintain the normal wound care protocol. The wound should be cleaned, and a new layer of Stratamed should be applied.

For example: after an ablative laser procedure on the face, apply Stratamed twice per day for 5–6 days; around day 3 the detritus (dead tissue, blood, other organic matter) is softened and can be removed by gentle cleaning (same protocol as normal). After the cleaning (which also removes Stratamed), a new layer of Stratamed is applied.

Can the wound on which you have applied Stratamed be washed?

Yes. The wound can be exposed to water but Stratamed will not protect it like a water proof dressing. Gentle washing will remove Stratamed from open wounds. It is important not to replace normal protective dressing with Stratamed but to apply Stratamed first, under the secondary protective dressing. The key to application and cleaning of the wounds is NOT to change the existing protocols that the doctor uses but to add Stratamed as the first layer in contact with the wound.

What about infected wounds or wounds that are at risk of becoming infected?

The infection protocol should not change in this case. If the area looks like it is infected or is at risk of being infected, then the wound should be cleaned and debrided, with topical antibiotic applied first followed by Stratamed applied over the antibiotic. If the wound is not infected then Stratamed should be applied directly to the skin. Note that Stratamed will enhance antibiotic’s effect because of its semi-occlusive nature. Stratamedis bacteriostatic but not bactericidal.

Can Stratamed be used in case of incontinence dermatitis?

Yes. As with other compromised skin conditions Stratamed will provide a flexible sheet that protects the skin from microbial and chemical invasion, improves hydration, and leads to a reduction in the inflammatory response and accelerated wound healing.

Can Stratamed be used on a 7 month old scar?

Stratamed is specifically designed for its application directly on open wounds. It is mainly used in the clinic for assisting wound surgery closures, laser resurfacing or chemical peels.

Stratpharma does offer another product called Strataderm; its mechanism of action is similar to that of Dermatix, however it is a once daily application as Strataderm will dry faster and last longer on your scar. (www.strataderm.com)

For the best results it is important to keep the gel in contact with your scar 24hrs/day 7 days/week. Only a very small amount is required for each application.

Why is Stratamed less viscous than Strataderm?

Stratamed was formulated with a different mixture of liquid silicones in order to not to stick to the Stratum corneum and/or granulating tissue of a wound.

Can Stratamed be used on common viral lesions - Herpes Simplex (cold sores), Herpes Zoster (shingles) and Varicella (chicken pox)?

Stratamed will not treat the underlying pathogenesis, however, it may assist with providing relief from the diffuse pruritus (itchiness) commonly associated with these lesions, as well as the associated initial pain of herpes simplex and zoster eruptions. Stratamed acts as a thin flexible wound dressing providing hydration and barrier protection for these patients. Stratamed is the only topical silicone gel that can be applied immediately to the “fresh” lesions, (especially with areas of broken skin) prior to re-epithelialization thereby protecting and hydrating the affected area sooner.

Research indicates that the faster traumatised skin re-epithelializes the lower the risk of developing an abnormal scar. Stratamed increases this process as well as reduces the inflammatory response hence decreases this scarring risk.

Wound treatment protocols should not change. Stratamed is recommended as an “add on” therapy to standard varicella and zoster protocols for patient comfort and scarring prevention.

For example, advice for treating lesions in a patient with standard chicken pox infection: Patients should have cool baths several times per day in an antiseptic solution such as Betadine or calamine solution for up to 20 minutes. Longer baths add to hydration of the epidermis and patient comfort. Any lesions with crustings or scabs should be removed during the bathing process. Patients should pat dry (not rub) their lesions post bath and only use the towel once. Stratamed can then be applied to the dry lesions. If there is a secondary bacterial infection present, then a topical antibiotic ointment should be applied prior to the Stratamed application.

If Stratamed is applied over other topical medications it will act as a semi-occlusive dressing and will potentially enhance the effect of the topical treatment underneath.

If Stratamed is applied under another topical medication Stratamed it will act as a barrier and will diminish or block the activity of the product being applied on top.

It is also important to remember that Stratamed is bacteriostatic, so will not harbour or encourage secondary bacterial infections.

If you consider that Stratamed needs to be applied more often than twice per day during the initial eruption phase of the lesions, then this is reasonable, as silicone gel is not absorbed below the dermal level and that “over dosing” of the product is not possible. If too much product is applied the gel simply will not dry, and this may be advantageous in the initial phase when pruritus is intense and unrelenting. Subjectively, patients report immediate symptom relief after re-application and you may choose to use individual patient’s symptoms as your guide for dosing instructions in the acute inflammatory phase. We have many case reports of patients applying the gel three to four hourly in the first couple of days to aid in symptom relief. Every time your patient cleans their lesions a fresh application of Stratamed is advised to ensure 24/7 contact. Some patients, particularly in hotter climates, find keeping the Stratamedtube in the refrigerator gives added comfort during application.

Patients should also be advised to cut their fingernails short, try not to overheat and avoid scratching at all costs!

Silicones1-3 have been used topically in medical treatments for over 30 years and the literature on its safety and efficacy is extensive. Stratamedis a medical grade silicone that is inert and pH neutral. The gel will not sting on application. The silicones contained in Stratamed have excellent biocompatibility due to its low chemical reactivity, its low surface energy and its hydrophobicity. Stratamed is non-toxic, not mutagenic or irritating. Other active silicones are used as anti-flatulent and in stomach formulations, as well as food preservatives. Stratamed is safe if it is ingested, licked, eaten by children or inserted accidentally into an orifice!

1. Gold MH et al. Dermatol Surg 2014; 40:817–824
2. Berman B et al. Dermatol Surg 2007; 33:1291–1303
3. Gold MH et al. Dermatol Surg 2001; 27:641–644

What happens if the patient ingests Stratamed?

Silicones have been used topically in medical treatments for over 30 years and the literature on its safety and efficacy is extensive. Stratamed is a medical grade silicone that is inert and pH neutral. The gel will not sting on application. The silicones contained in Stratamed have excellent biocompatibility due to its low chemical reactivity, its low surface energy and its hydrophobicity. Stratamed is nontoxic, not mutagenic or irritating. Other active silicones are used as anti-flatulent and in stomach formulations, as well as food preservatives. Stratamed is safe if it is ingested, licked, eaten by children or inserted accidentally into an orifice.

Can you use Stratamed on a 6 month old scar?

Strataderm in contrast to Stratamed is specifically formulated to be applied to skin that has a stratum corneum (dead skin layer) like on a scar, to ’bond’ to this layer and form a durable sheet. Stratamed is used to soften and flatten scars, relieve the itching and discomfort of scars as well as reduce redness and discoloration associated with scars.

Stratamed follows a simple volume usage rule:

  • Tube of 10 g (0.35 oz) is enough to treat a 5–7 cm (2–3 inch) linear scar for over 90 days.
  • Tube of 20 g (0.7 oz) is enough to treat a 10–14 cm (4–6 inch) linear scar for over 90 days.

90 days is the minimum required usage time of Stratamed. If you continue to see improvement after the recommended use time, you should continue applying until no further improvement is seen.

I am interested in distributing Stratamed in my country. Whom may I contact to discuss a business relationship?

Please contact our sales department at inquiries[at]stratpharma.com

I am organizing a study about skin care/scar therapy and I am interested to cooperate with you to test the product within this study. Could you please contact me?

Yes. Please submit your enquiry to our medical department at medical[at]stratamed.com and we will be happy to contact you.

I am working in a hospital and would like to offer some product samples to my patients. Can you provide some?

Currently we don't offer samples of Stratamed through our website. We may offer trial packs for hospitals or doctors. Please contact us at customerservice[at]stratamed.com for such inquiries.

We are interested in selling your product in our office. Could you please have a representative call me and give me more information?

Yes. Please submit your enquiry and your contact details to our customer service at customerservice[at]stratamed.com.