AQUACEL® Ag Advantage combines two technologies – Hydrofiber™ and MORE THAN SILVER™ - to effectively manage biofilm within the dressing.
• Kills a broad spectrum of bacteria within the dressing, including antibiotic resistant microorganisms
• Sustained antimicrobial activity in dressing up to seven days and prevents microbial reformation
• Ethylenediaminetetraacetic acid disodium salt (EDTA) helps break up bacterial aggregates and prevents their formation and reformation
• Benzethonium chloride (BEC) is a surfactant that reduces the viscosity or surface tension of anything to which it comes in contact, including exudate and microorganisms, which allows for increased mobility of EDTA and ionic silver within the dressing, enhancing the ionic silver's ability to contact and kill microorganisms
• Silver in the dressing kills microorganisms held within the dressing; these include bacteria, yeasts and mold and provides an antimicrobial barrier to protect the wound bed
• Absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement)
Under the supervision of a health care professional, AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber may be used as stated in the Instructions for Use for the management of: wounds as an effective barrier to bacterial penetration of the dressing, as this may help reduce the risk of infection; partial-thickness (second-degree) burns; diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/injuries (partial- and full-thickness); surgical wounds left to heal by secondary intention such as dehisced surgical incisions; surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular); traumatic wounds; wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; oncology wounds with exudate, such as fungoides, cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma; painful wounds; infected wounds.
AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components (ionic silver, ethylenediaminetetraacetic acid disodium salt (EDTA) and benzethonium chloride).
• Caution: Sterility is guaranteed unless pouch is damaged or opened prior to use.
• This device is for single-use only and should not be reused. Re-use may lead to increased risk of infection or cross contamination. Physical properties of the device may no longer be optimal for intended use.
• When dressing sinus, tracking/tunneling or undermining wounds use AQUACEL® Ag Advantage Ribbon with strengthening fiber.
• During the body's normal healing process, nonviable tissue is removed from the wound (autolytic debridement), which could initially make the wound appear larger. If the wound continues to grow larger after the first few dressing changes, consult a health care professional. The wound should be inspected during dressing changes. Consult a health care 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) hypergranulation (excessive tissue formation), g) sensitivity (allergic reaction), h) no signs of healing.
• If you have difficulty removing the dressing, it should be soaked with water or sterile saline until it removes easily.
For partial-thickness burns, please refer to the FOR PARTIAL-THICKNESS BURNS (SECOND-DEGREE BURNS) section of this package insert.
• Because AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber provides a moist environment that supports the growth of new blood vessels, the delicate, newly formed blood vessels may occasionally produce blood stained wound fluid.
• AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber is not compatible with oil-based products, such as petrolatum.
• Secondary dressings should be used as stated in the DIRECTIONS FOR USE Section.
In addition, for leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), diabetic ulcers, pressure ulcers/injuries, partial-thickness (second-degree) burns, donor sites and surgical, oncology or traumatic wounds left to heal by primary or secondary intention:
• Treatment of wounds listed above should be under the supervision of a health care professional.
• Appropriate supportive measures should be taken where indicated (e.g., use of graduated compression bandaging in the management of venous leg ulcers or pressure relief measures in the management of pressure injuries, systemic antibiotics and frequent monitoring in the treatment of wound infection, control of blood glucose for diabetic ulcers, etc.).
• For oncology wounds, a secondary dressing of high absorbency may be required.
• AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber is not intended for use as a surgical sponge.
• The use of AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber has not been studied in wounds due to herpes simplex or impetigo.
• Clinicians/health care professionals should be aware that there are very limited data on prolonged and repeated use of silver containing products, particularly in children and neonates.
• MR-Safe. AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber is determined to be MR-Safe according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-13 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
• Blue skin discoloration (i.e., Argyria) may occur after prolonged contact with a silver-containing material. Frequent or prolonged use of this preparation may result in permanent discoloration of skin and mucous membranes.
This product is for single use only and is supplied sterile.
Discard any unused portion of the product after dressing the wound.
If the immediate product packaging is damaged, do not use.
The following adverse reactions have been identified during use of AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber:
• Skin irritation/rash/mucosal irritation
• Allergic response (localized)
• Mild pain/discomfort
• Superficial tissue damage
• Delayed healing/abnormal scarring of wound
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber dressing exposure. The absolute number of adverse events is unknown, but believed to be very low. Such events are generally transitory in nature and should resolve shortly after discontinuing treatment with the dressing. Should symptoms persist or worsen please seek medical advice.
Store at room temperature (10⁰C-25⁰C, 50⁰F-77⁰F). Keep dry.
|Absorptive dressing format||●|
|Alginate dressing format|
|Antimicrobial effects up to 48 hours|
|Antimicrobial effects up to 3 days|
|Antimicrobial effects up to 7 days||●|
|Collagen dressing format|
|Composite dressing format|
|Contact layer dressing format|
|Foam dressing format|
|Gauze or non-woven dressing format|
|Gelling fiber dressing format||●|
|Hydrogel (amorphous) dressing format|
|Hydrogel (impregnated) dressing format|
|Hydrogel (sheet) dressing format|
|Impermeable to outside contaminants|
|Impregnated dressing format|
|Moisture vapor permeable|
|Secondary dressing required||●|
|Super absorbent polymers|
|Sustained release formula|
|Transparent film dressing format|
|Wound filler dressing format||●|
|Educational Material Available||●|
|Free Samples/Trials Available||●|
|Published Clinical Article Available||●|
Granulating/ Epithelializing Wounds
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
• Before applying the dressing, cleanse the wound area with an appropriate wound cleanser.
• AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber should overlap at least 1cm (1/2") onto the skin surrounding the wound.
• When using AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber in deep wounds, only fill the wound up to 80%, as the dressing will expand to fill the wound space on contact with wound fluid.
• This primary dressing should be used with a secondary cover dressing. Apply the dressing to the wound and cover with a moisture retentive dressing, gauze or other appropriate dressing. See individual cover dressing package inserts for complete instructions for use.
• All wounds should be inspected frequently. Remove the AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber when clinically indicated (i.e., leakage, excessive bleeding, increased pain) or after a maximum of seven days.
For partial-thickness burns (second-degree burns) and donor sites:
• Before applying the dressing, cleanse the wound area with an appropriate wound cleanser.
• AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber should overlap 5cm (2") onto the skin surrounding the burn or other adjacent AQUACEL®Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber.
• The AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber may be covered with a suitable absorbent dressing pad and secured appropriately.
• Remove the cover dressing periodically and inspect the AQUACEL® Ag Advantage enhanced Hydrofiber®™ dressing with silver and strengthening fiber while leaving it in place on the burn.
• In this indication, adherence to the wound bed of the AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber is a desired characteristic.
• Adhered dressing can be left in place; any areas that have not adhered should be left intact unless clinically indicated or if the dressing is saturated or leaking. Where a part of the dressing has been removed, a new dressing may be applied over the top of the existing adhered dressing.
• Adherence of the dressing over joints could interfere with movement.
• As the burn wound reepithelializes, the AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber will detach or be easily removed.
• Remove the AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber when clinically indicated (e.g, excessive bleeding, clinical signs of infection).
• If adhered dressing needs to be removed before the wound has healed, it should be thoroughly saturated with sterile saline or sterile water until fully softened to ease removal and prevent damage to delicate tissues.
• If the wound has not reepithelialized 14 days after the initial partial-thickness (second-degree) burn injury, consider seeking further advice as surgical intervention may be required.
For dry wounds and minimally exuding wounds:
• Place the AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber in the wound and then wet with sterile saline over the wound area only. The vertical absorption properties of AQUACEL® Ag Advantage enhanced Hydrofiber® dressing with silver and strengthening fiber will help to maintain the moist area over the wound only and reduce the risk of maceration.
• Cover the dressing with a moisture retentive dressing to avoid drying out of the dressing and subsequent dressing adherence to the wound.
ConvaTec is a global medical device and technologies company focused on therapies for the management of acute and chronic wounds, with a leading market position in advanced wound care. ConvaTec products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.