Instructions for Use (IFU)

This page is intended for Healthcare Professionals: The information on this page is intended for healthcare professionals. Patient-specific information is available in the “Patients” section of this site. Patients should consult a healthcare professional regarding specific medical conditions and treatments.

Document versions: Labeling featured on this page represents the latest released version and may not match the labeling currently accompanying the product.

Product availability: Products described on this website (and associated product information), may not be available for sale in all markets as a result of local regulatory requirements. For information regarding product availability in your market, please contact your local Imbed Biosciences representative.

Safety information: Specific indications, contraindications, warnings, precautions and safety information exist for Imbed Biosciences products.

Instructions

2″ x 2″ (5 cm x 5 cm)
4″ x 4″ (10 cm x 10 cm)

Description

Microlyte® Matrix is a sterile, single use absorbent polymeric matrix wound dressing composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/in2.

Mechanism of Action

Microlyte® Matrix absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. The dressing contains silver only to prevent or minimize microbial growth within the dressing.

Intended Use

Microlyte® Matrix is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte® Matrix may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte® Matrix may be used over debrided and grafted partial thickness wounds.

Indications For Use

For over-the-counter use, Microlyte® Matrix may be used for abrasions, lacerations, minor cuts, and minor scalds and burns. Under the supervision of a healthcare professional, Microlyte® Matrix may be used for the management of:

  • Wounds

  • Partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds

  • May be used over debrided and grafted partial thickness wounds

Directions For Use

  • Clean the wound area using sterile saline solution.
  • If the wound is dry, moisten it with sterile saline and remove excess saline with sterile gauze.
  • Avoid contact with wet surfaces until placed on a moist wound bed.
  • Cut Microlyte® Matrix to size slightly larger than the wound. Multiple sheets can be used to tile the entire wound area.
  • Apply Microlyte® Matrix directly to wound bed. When placed on a moist wound bed, the dressing forms a soft conforming sheet.
  • Microlyte® Matrix should be used with a secondary cover dressing. Cover with a moisture retentive dressing such as, a film dressing, foam dressing, wet-to-dry gauze or other appropriate dressing. See individual cover dressing package inserts for complete instructions for use. All dressing site areas should be inspected daily.
  • Reapply Microlyte® Matrix daily or up to every 3 days, depending on the wound and the healing progression, or when clinically indicated (e.g. leakage, excessive bleeding, increased pain).
  • To reapply, carefully remove the secondary cover dressing. Gently irrigate wound with sterile saline to remove necrotic tissue. It is not necessary to remove any residual Microlyte® Matrix observed during secondary cover dressing changes.
  • Change the secondary cover dressing as needed or when Microlyte® Matrix is re-applied.
  • Duration of treatment depends on wound type and healing conditions.

Precautions For Use

  • Warning: Frequent or prolonged use of this product may result in permanent discoloration of skin.
  • Warning: Avoid use with iodophore containing products that may reduce the effectiveness of silver in the dressing.
  • The wound should be inspected during cover dressing changes. Consult a healthcare professional if you see (a) signs of infection (increased pain, increased redness, wound drainage), (b) bleeding, (c) a change in wound color and/or odor, (d) irritation (increased redness and/or inflammation), (e) maceration (skin whitening), (f) hyper-granulation (excessive tissue formation), (g) sensitivity (allergic reaction), (h) no signs of healing.
  • Secondary cover dressings should be used as stated in the “Directions for Use” section.
  • Microlyte® Matrix should not be used with other wound care products other than those listed in the “Directions For Use” section without first consulting a healthcare professional.
  • This product contains <0.5 mg/in2 polyethylene glycol (400 Da).

For pressure ulcers, venous stasis ulcers, diabetic ulcers, first-and second-degree burns, donor sites, skin grafts and surgical wounds:

  • Treatment of wounds listed above should be under the supervision of a healthcare professional.
  • Appropriate supportive measures should be taken where indicated. For example, use of granulated compression in the management of venous leg ulcers, or pressure relief measures in the management of pressure ulcers, systemic antibiotics and frequent monitoring in the treatment of wound infection, control of blood glucose for diabetic ulcers, etc.

Safety & Effectiveness

Preclinical testing has been performed on Microlyte® Matrix and its biocompatibility has been demonstrated through appropriate in vitro and in vivo tests, including cytotoxicity, acute systemic toxicity, subacute/sub-chronic toxicity, acute intracutaneous reactivity, skin sensitization, and tissue implantation tests. Sustained antimicrobial activity for up to 3 days has been demonstrated by relevant standard in vitro microbiological assays in simulated wound fluid. Microlyte® Matrix was shown to be effective in killing more than 4 log10 CFUs of microbes most frequently associated with wound infections, including, S. aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), P. aeruginosa (ATCC 9027), E. coli (ATCC 8739), K. pneumoniae (ATCC 4352), C. tropicalis (ATCC 750) and C. albicans (ATCC 10231). The product has been determined to be non-pyrogenic.

Contraindications

Do not use on individuals who are sensitive to silver or who have had an allergic reaction to Microlyte® Matrix or one of its components.

Storage Conditions

Store at room temperature (15°C/59°F – 30°C/86°F). Keep dry.
If further information is needed, please contact Imbed Biosciences Inc.

How Supplied

Microlyte® Matrix is individually packaged in foil pouches and supplied in boxes of 5 units. Sterilization by E-beam radiation. Sterility is guaranteed unless pouch is damaged or opened. Single use only.

REF. 91001 2 inch x 2 inch (5 cm x 5 cm)
REF. 91002 4 inch x 4 inch (10 cm x 10 cm)

Manufactured By

Imbed Biosciences, Inc.
5520 Nobel Drive, Suite 100, Madison, WI 53711
Ph: 608.237.1525 | Fax: 608.729.7183 | www.MicrolyteMatrix.com
Made in USA © 2019 Microlyte® is a registered trademark of
Imbed Biosciences, Inc.

Explanation of Symbols

Batch code

Part number

Caution, consult
documentation

Sterilized using
e-beam radiation

Re-use is not allowed

Do not use if
package is damaged

Use by date

Store between
15°C/59°F and 30°C/86°F

Latex-free

Manufacturer

Download PDF

Indications for Use (IFU)

This page is intended for Healthcare Professionals: The information on this page is intended for healthcare professionals. Patient-specific information is available in the "Patients" section of this site. Patients should consult a healthcare professional regarding specific medical conditions and treatments.

Document versions: Labeling featured on this page represents the latest released version and may not match the labeling currently accompanying the product.

Product availability: Products described on this website (and associated product information), may not be available for sale in all markets as a result of local regulatory requirements. For information regarding product availability in your market, please contact your local Imbed Biosciences representative.

Safety information: Specific indications, contraindications, warnings, precautions and safety information exist for Imbed Biosciences products.

Instructions

2" x 2" (5 cm x 5 cm) 4" x 4" (10 cm x 10 cm)

Description

Microlyte® Matrix is a sterile, single use absorbent polymeric matrix wound dressing composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/in2.

Mechanism of Action

Microlyte® Matrix absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. The dressing contains silver only to prevent or minimize microbial growth within the dressing.

Intended Use

Microlyte® Matrix is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte® Matrix may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte® Matrix may be used over debrided and grafted partial thickness wounds.

Indications For Use

For over-the-counter use, Microlyte® Matrix may be used for abrasions, lacerations, minor cuts, and minor scalds and burns. Under the supervision of a healthcare professional, Microlyte® Matrix may be used for the management of:

  • Wounds
  • Partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, abrasions and lacerations, donor sites and surgical wounds
  • May be used over debrided and grafted partial thickness wounds

Directions For Use

  • Clean the wound area using sterile saline solution.
  • If the wound is dry, moisten it with sterile saline and remove excess saline with sterile gauze.
  • Avoid contact with wet surfaces until placed on a moist wound bed.
  • Cut Microlyte® Matrix to size slightly larger than the wound. Multiple sheets can be used to tile the entire wound area.
  • Apply Microlyte® Matrix directly to wound bed. When placed on a moist wound bed, the dressing forms a soft conforming sheet.
  • Microlyte® Matrix should be used with a secondary cover dressing. Cover with a moisture retentive dressing such as, a film dressing, foam dressing, wet-to-dry gauze or other appropriate dressing. See individual cover dressing package inserts for complete instructions for use. All dressing site areas should be inspected daily.
  • Reapply Microlyte® Matrix daily or up to every 3 days, depending on the wound and the healing progression, or when clinically indicated (e.g. leakage, excessive bleeding, increased pain).
  • To reapply, carefully remove the secondary cover dressing. Gently irrigate wound with sterile saline to remove necrotic tissue. It is not necessary to remove any residual Microlyte® Matrix observed during secondary cover dressing changes.
  • Change the secondary cover dressing as needed or when Microlyte® Matrix is re-applied.
  • Duration of treatment depends on wound type and healing conditions.

Precautions For Use

  • Warning: Frequent or prolonged use of this product may result in permanent discoloration of skin.
  • Warning: Avoid use with iodophore containing products that may reduce the effectiveness of silver in the dressing.
  • The wound should be inspected during cover dressing changes. Consult a healthcare professional if you see (a) signs of infection (increased pain, increased redness, wound drainage), (b) bleeding, (c) a change in wound color and/or odor, (d) irritation (increased redness and/or inflammation), (e) maceration (skin whitening), (f) hyper-granulation (excessive tissue formation), (g) sensitivity (allergic reaction), (h) no signs of healing.
  • Secondary cover dressings should be used as stated in the “Directions for Use” section.
  • Microlyte® Matrix should not be used with other wound care products other than those listed in the “Directions For Use” section without first consulting a healthcare professional.
  • This product contains <0.5 mg/in2 polyethylene glycol (400 Da).

For pressure ulcers, venous stasis ulcers, diabetic ulcers, first-and second-degree burns, donor sites, skin grafts and surgical wounds:

  • Treatment of wounds listed above should be under the supervision of a healthcare professional.
  • Appropriate supportive measures should be taken where indicated. For example, use of granulated compression in the management of venous leg ulcers, or pressure relief measures in the management of pressure ulcers, systemic antibiotics and frequent monitoring in the treatment of wound infection, control of blood glucose for diabetic ulcers, etc.

Safety & Effectiveness

Preclinical testing has been performed on Microlyte® Matrix and its biocompatibility has been demonstrated through appropriate in vitro and in vivo tests, including cytotoxicity, acute systemic toxicity, subacute/sub-chronic toxicity, acute intracutaneous reactivity, skin sensitization, and tissue implantation tests. Sustained antimicrobial activity for up to 3 days has been demonstrated by relevant standard in vitro microbiological assays in simulated wound fluid. Microlyte® Matrix was shown to be effective in killing more than 4 log10 CFUs of microbes most frequently associated with wound infections, including, S. aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), P. aeruginosa (ATCC 9027), E. coli (ATCC 8739), K. pneumoniae (ATCC 4352), C. tropicalis (ATCC 750) and C. albicans (ATCC 10231). The product has been determined to be non-pyrogenic.

Contraindications

Do not use on individuals who are sensitive to silver or who have had an allergic reaction to Microlyte® Matrix or one of its components.

Storage Conditions

Store at room temperature (15°C/59°F – 30°C/86°F). Keep dry. If further information is needed, please contact Imbed Biosciences Inc.

How Supplied

Microlyte® Matrix is individually packaged in foil pouches and supplied in boxes of 5 units. Sterilization by E-beam radiation. Sterility is guaranteed unless pouch is damaged or opened. Single use only.

REF. 91001 2 inch x 2 inch (5 cm x 5 cm) REF. 91002 4 inch x 4 inch (10 cm x 10 cm)

Manufactured By

Imbed Biosciences, Inc. 5520 Nobel Drive, Suite 100, Madison, WI 53711 Ph: 608.237.1525 | Fax: 608.729.7183 | www.MicrolyteMatrix.com Made in USA © 2019 Microlyte® is a registered trademark of Imbed Biosciences, Inc.

Explanation of Symbols

Batch code

Part number

Caution, consult documentation

Sterilized using e-beam radiation

Re-use is not allowed

Do not use if package is damaged

Use by date

Store between 15°C/59°F and 30°C/86°F

Latex-free

Manufacturer

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