Instructions for Use (IFU)
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Instructions
2″ x 9″ (5 cm x 23 cm)
4″ x 9″ (10 cm x 23 cm)
6″ x 6″ (15 cm x 15 cm)
Description
Microlyte® Surgical 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® Surgical 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® Surgical 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® Surgical 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® Surgical may be used over debrided and grafted partial thickness wounds.
Indications For Use
Under the supervision of a healthcare professional, Microlyte® Surgical 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® Surgical to size slightly larger than the wound. Multiple sheets can be used to tile the entire wound area.
- Apply Microlyte® Surgical directly to wound bed. When placed on a moist wound bed, the dressing forms a soft conforming sheet.
- Microlyte® Surgical 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® Surgical 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® Surgical observed during secondary cover dressing changes.
- Change the secondary cover dressing as needed or when Microlyte® Surgical 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® Surgical 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® Surgical 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® Surgical 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® Surgical 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® Surgical 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. 91006 2 inch x 9 inch (5 cm x 23 cm)
REF. 91007 4 inch x 9 inch (10 cm x 23 cm)
REF. 91008 6 inch x 6 inch (15 cm x 15 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 © 2020 Microlyte® is a registered trademark of
Imbed Biosciences, Inc.
Explanation of Symbols
 | Batch Code |  | Do not use if package is damaged |
 | Part number |  | Use by date |
 | Caution, consult documentation |  | Store between 15°C/59°F and 30°C/86°F |
 | Sterilized using e-beam radiation |  | Latex-free |
 | Re-use is not allowed |  | Manufacturer |