G4Derm® Plus Biomimetic Matrix
G4Derm® Plus is an acellular flowable extracellular matrix (ECM) designed to optimally manage complex wounds. It supports healing and serves as an antibacterial barrier to protect the wound bed from external contamination. G4Derm Plus utilizes self-assembling peptide technology to form a scaffold that mimics the native ECM. The resorbable biomimetic matrix (BMM™) facilitates revascularization, granulation tissue formation, and re-epithelialization.
MIMEDX Group, Inc.
MIMEDX is a pioneer and leader in placental biologics focused on delivering innovative solutions to patients and the health care professionals who treat them. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX has been dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical recovery sectors of health care.Benefits
• Conforms to irregular wound geometries and eliminates dead space
• Serves as a durable antibacterial barrier
• Comes as a ready-to-use, pre-filled Syringe with a flexible Applicator Tip, and is shelf stable for up to 3 years
• Flowable
• Shelf life greater than 2 years
• Indicated for acute wounds
• Indicated for chronic wounds
Indications
G4Derm Plus may be used under the supervision of health care professionals for the local management of partial-and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns.
Contraindications
Do not use G4Derm Plus on patients with a known sensitivity/previous allergic reaction to the product or any of its components.
No contraindications related to contaminated wounds.
Warnings and Precautions
• Keep out of the reach of children.
• Not for injection.
• The recommended maximum patient exposure of G4Derm Plus is 10 g/day.
• G4Derm Plus is a sterile product. Do not re-sterilize.
• Product is guaranteed to be sterile and nonpyrogenic unless the package is opened or damaged.
• Do not use G4Derm Plus if the package seal is broken.
• Apply the product promptly after opening the package to prevent contamination.
• To minimize the possibility of cross-contamination, the contents of one pre-filled syringe should be used during a single patient procedure only.
• Thoroughly wash and dry hands before using the product.
• When applicable, use sterile gloves to prevent contamination.
• Discard product if mishandling has caused possible damage or contamination.
Storage Requirements
• Up to 3-year shelf life
• Store at +2°C to +30°C (+36°F to +86°F) in dry area
• Avoid freezing
Product features
Indicated for chronic vascular ulcers
Indicated for diabetic ulcers
Indicated for draining wounds
Indicated for partial- and full-thickness wounds
Indicated for pressure ulcers
Indicated for surgical wounds
Indicated for third-degree burns
Indicated for trauma wounds
Indicated for venous ulcers
Variety of sizes
Contact manufacturer for usage guidelines
Recommended Use
Plastic Reconstruction
Foot and Ankle
Trauma
General
Vascular
Orthopedic
Spine
Burns
Mode of Use/Application
Before Use: Read Instructions for Use. G4Derm Plus is intended for use in adults 18 years of age or older. Confirm there is no damage to pouches, Syringe, or flexible Applicator Tip. Do not use the product if damaged or leaks are noted. Do not use the product if the Syringe top cap is disconnected.
Clean and prepare the wound area including debridement when appropriate. Thoroughly dry the surrounding skin.
From the non-sterile field, peel open the single pouch using aseptic technique and transfer the sterile G4Derm Plus Syringe (and optional flexible Applicator Tip, if needed) to the sterile field.
Hold the Syringe and remove the top cap.
Optional: If using the flexible Applicator Tip for application, connect the flexible Applicator Tip by securely attaching it to the syringe head. Prior to G4Derm Plus application, prime the Syringe by gently pulling the plunger rod backward until you feel a slight resistance to release the vacuum within the Syringe.
Dispense G4Derm Plus directly onto the wound by gently pressing the plunger rod.
Apply enough product to coat the wound bed. Fill any void spaces.
Precaution: The recommended maximum patient exposure of G4Derm Plus is 10 g/day
10g of G4Derm Plus = 5 units of 2 mL
After product application, cover with appropriate non-absorbent, non-adherent contact layer.
Examples of recommended non-petrolatum and non-absorptive dressings:
Adpatic® Touch, Mepitel® (soft silicone), and Telfa®.
DO NOT APPLY the following products directly on G4Derm Plus: The foam used for Negative Wound Pressure Therapy (NWPT), absorbent dressings, silver dressings, and antibiotic beads.
Secondary dressing is determined by wound characteristics and clinician preference.
Re-application: G4Derm Plus should be reapplied at dressing changes as needed.
Note: The majority of G4Derm Plus is bioresorbed in approximately 7 to 10 days after application.
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