What is PermeaDerm^®? PermeaDerm is a unique, patented, dual layer biosynthetic wound matrix that acts as an epidermal analogue until re-epithelialization.^1,2 PermeaDerm^® B, C and Glove provide a moist wound healing environment on cleanly debrided non-infected wounds after hemostasis has been established.

1. Woodroof A. et al, Eplasty. 2015. July e30. 2. FDA PermeaDerm 510(K) Premarket Notification.

  What are the PermeaDerm indications for use? PermeaDerm is indicated for partial-thickness burn wounds and other partial-thickness wounds, pressure ulcers (sores), venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Mohs, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second- degree burns, and skin tears) and draining wounds, donor sites and coverage of meshed autograft. ¹ PermeaDerm Glove is indicated for debrided partial-thickness hand burns. ¹

1. PermeaDerm Instructions for Use

  What is PermeaDerm made of? PermeaDerm is a dual layer, fenestrated wound matrix. The outer layer of PermeaDerm is a 2D silicone epidermal analogue, while the inner layer is a 3D micro-support system with biocoating containing a hypoallergenic porcine gelatin and aloe vera.     What are the advantages of using PermeaDerm instead of allograft for wound management? PermeaDerm offers several key advantages over allograft:

• Significant economic advantage¹
• Transparency allows for wound visualization and assessment^2-3
• Tissue tracking is not required¹
• PermeaDerm can be stored at room temperature for up to 5 years¹
• Ease of wound and exudate management^2-3
• No risk of disease transmission⁴

1. Data on file. 2. Woodroof A, Phipps R, Woeller C, et al. Evolution of a biosynthetic temporary skin substitute: A preliminary study. Eplasty. 2015;Jul 20:15:e30. 3. FDA PermeaDerm 510(k) Premarket Notification 4. Voigt C, Williamson S, Kagan R, et al. The Skin Bank. Total Burn Care. 2018.

  How is PermeaDerm applied?

• Thoroughly debride/excise wound to remove all loose or necrotic tissue
• Remove PermeaDerm from the packet using aseptic technique
• Place 3D micro-support system side against debrided wound (“This Side Up” label should face away from the wound)
• Ensure application is wrinkle-free with slight tension (≤10% elongation; minimize elongation when using on face)
• Secure PermeaDerm via standard methods (e.g., staples, tape, sutures, skin glue)
• Place secondary dressing over PermeaDerm to absorb exudate and blood from the wound
• Remove outer and secondary dressings to check wound after initial 24-36 hours
• Leave PermeaDerm in place until healing occurs. PermeaDerm will peel away easily from healed skin

  Should PermeaDerm be stretched before placement? Ensure wrinkle-free application by gently stretching PermeaDerm with slight tension (≤10% elongation; minimize elongation when using on face).   Does PermeaDerm allow for easy wound monitoring? The transparency of PermeaDerm allows at-a-glance wound assessment with a clear view to the wound healing process, minimizing disruptions to the patient, the wound, or the dressing itself.   How long should PermeaDerm remain in place? The primary adherence of PermeaDerm occurs within 5 hours due to clot formation within the inner 3D micro-support system.^1-4 Secondary adherence occurs typically within 72 hours with newly formed tissue generated in the wound bed to support re-epithelialization.^1-4 Keratinocytes migrate under the 3D micro-support system and re-epithelialization is achieved.^1-4 Healing is typically complete within 7-14 days and PermeaDerm will peel off from the healed tissue relatively easily.^1-4

1. Woodroof A. et al, Eplasty. 2015. July e30. 2. FDA PermeaDerm 510(K) Premarket Notification. 3. Greenwood, JE et al. Eplasty. 2011. Feb e10. 4. Greenwood, JE et al. Eplasty. 2009. June e25.

  Does PermeaDerm keep the wound bed moist? PermeaDerm offers customizable moisture management (defined porosity through stretch). To achieve optimal wound moisture management, apply PermeaDerm as directed with appropriate compression to achieve early adherence.   How should PermeaDerm be removed? PermeaDerm will appear dry and flaky as it lifts off the wound while the wound heals underneath. Loose edges can be trimmed and emollients can be applied to the PermeaDerm to aid in removal.  In general, most PermeaDerm will come off by 14 days.   What happens if there is an infection under PermeaDerm? The transparent nature of PermeaDerm allows for identification of suspicious drainage. PermeaDerm should be removed from wound areas showing signs of infection and treated with a non-oily topical antimicrobial per standard of care.   Can the patient shower with PermeaDerm in place? Yes. Once PermeaDerm is well adhered, usually by 72 hours, the patient can shower with minimal moisture contact, as long as the PermeaDerm is not submerged or under a direct stream of water.   Can PermeaDerm be left open to air? Yes. Once PermeaDerm is well adhered – usually by 72 hours – outer dressings can be removed to allow ambient air exchange and oxygenation of the wound bed.   How should PermeaDerm be dressed? A variety of dressings can be used to assist with wicking of exudate, including Kerlix™ or burn gauze.  Then use an outer wrap such as an ACE™ bandage to apply slight compression to ensure PermeaDerm stays in intimate contact with the wound. Once blood or fluid exudation through PermeaDerm has ceased and adherence has been achieved, PermeaDerm no longer requires outer dressings Emollient-based or oily products should not be applied to PermeaDerm for the first 3-5 days or until the PermeaDerm is securely adhered.   Is PermeaDerm waterproof? No, although PermeaDermis highly water resistant.   Are there any contraindications for PermeaDerm? PermeaDerm use is contraindicated for use on any patient with a known allergy to porcine or Aloe vera materials.¹

1. PermeaDerm Instructions for Use