Endoform™ Antimicrobial is an advanced extracellular matrix (ECM) containing 0.3% ionic silver for acute and chronic wounds. Incorporates into the wound and provides a porous bioscaffold to help build new tissue.
• Provides broad-spectrum protection against antimicrobial colonization of the device for up to seven days and helps prevents biofilm formation
• Enables broad-spectrum wound protease modulation
• Helps indicate presence or absence of proteases and help restore protease balance and guide re-application rate
• Provides an advanced extracellular matrix (ECM) with an intact scaffold and 150+ ECM proteins to help build new tissue
• Compatible with NPWT, HBOT, compression therapy and offloading
• Accessible to health care professionals from day one
Endoform™ Antimicrobial is indicated for the management of acute and chronic wounds including partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Mohs surgery, post-laser surgery, podiatric and wound dehiscence), traumatic wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
Endoform™ Antimicrobial is derived from an ovine (sheep) source and should not be used on patients with known sensitivity to ovine (sheep) derived material or ionic silver.
Endoform™ Antimicrobial is not indicated for use on third degree burns.
Endoform™ Antimicrobial may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. Endoform™ Antimicrobial is not intended to be a substitute for appropriate treatment of infection.
Endoform™ Antimicrobial is terminally sterilized via ethylene oxide. Do not use if the pouch is damaged.
Discard the device if mishandling has caused possible damage or contamination.
Single use product. Do not re-sterilize. Discard all unused portions. Device reuse may lead to wound infection.
Always handle Endoform™ Antimicrobial using aseptic technique.
Do not use past expiry date.
Endoform™ Antimicrobial may cause transient discoloration of the wound bed and surrounding skin. Frequent or prolonged use of this product may result in permanent discoloration of the skin.
Reduction in colonization or microbial growth on the device has not been shown to correlate with a reduction in infections in patients. Clinical studies to evaluate reduction in infection have not been performed.
Health care professionals should be aware that there is limited data on prolonged and repeated use of silver containing dressings, particularly in pediatrics and neonates.
Users within the EU may access a Summary of Safety and Clinical Performance (SSCP) using Basic UDI-DI 0942190EDTBIOSCAFFOLD5Q through Eudamed (https://ec.europe.eu/tools/eudamed) or upon request.
Report any serious incident to Aroa Biosurgery via the local authorized representative (e.g. S4M Europe), as well the applicable Member State competent authority or other regulatory authority, in accordance with local requirements.
Endoform™ Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light. Endoform™ Antimicrobial, like other silver-containing products, may darken upon storage, after hydration in saline, when exposed to light, or when in contact with body fluids and tissues. This darkening does not affect product performance.
0.3% ionic silver
Acute Wounds
Burns
Cavity Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Palliative Wounds
Pressure Ulcers
Sloughy Wounds
Superficial Wounds
Surgical Wounds
Venous Ulcers
These recommendations are designed to serve only as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.
Prepare the wound bed by cleansing, irrigation and if necessary, debride to remove debris, necrotic tissue or infected tissue. Select a sheet of Endoform™ Antimicrobial which is slightly larger than the wound and apply aseptically. Endoform™ Antimicrobial can be applied as a whole sheet or trimmed so that it contacts the wound margins. Multiple sheets can be used to cover the entire wound bed. For ease of handling, apply the device by placing the dry material in the wound and rehydrating with exudate or sterile saline. When hydrated Endoform™ Antimicrobial transforms into a soft conforming sheet. Ensure that the device conforms to the underlying wound bed. To protect Endoform™ Antimicrobial from adhering to the secondary dressing, consider applying a non-adherent dressing over the device to help protect the tissue while facilitating an optimal moist wound healing environment. Secure the device using an appropriate secondary dressing. The secondary dressing should be changed according to standard of care and taking into account the level of exudate. Endoform™ Antimicrobial can be used in conjunction with compression therapy, off-loading, and negative pressure wound therapy.
Duration of treatment and reapplication is determined by the physician and depends upon the wound type and conditions. The biodegradable Endoform™ Antimicrobial is absorbed and incorporated into the wound over time. It is recommended to assess the wound within 72 hours. Reapply when the device has been incorporated into the wound. Endoform™ Antimicrobial may last from 1 day and up to 7 days in the wound, depending on the wound type and environment. Carefully cleanse the wound surface in accordance with established procedures. Do not attempt to remove the off-white to golden gel that forms from residual Endoform™ Antimicrobial in the wound as it contains extracellular matrix components that assist in wound healing. If areas of the device are dry upon inspection, rehydrate with sterile saline and leave in place. It is not necessary to remove any residual Endoform™ Antimicrobial during dressing changes. However, if the product has been overlapped onto the peri-wound area, the remaining loose product that has not incorporated into the wound may be gently removed around the edges if desired. Change the secondary dressings as needed according to standard of care, taking into account the level of exudate, and when Endoform™ Antimicrobial is re-applied.
Non-cytotoxic
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