AQUACEL® Ag Advantage SURGICAL cover dressings are sterile, post-operative dressings comprising an inner (wound contact) non-woven pad composed of 1.2% ionic silver impregnated sodium arboxymethylcellulose fiber with added ethylene-diaminetetraacetic acid disodium salt (EDTA) and benzethonium chloride, stitched with nylon and elastane. Pad is held in place between a top layer of hydrocolloid bound to an outer polyurethane film and a windowed skin contact hydrocolloid layer.
• 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 (including bacteria, yeasts and mold) and provides an antimicrobial barrier to protect the wound bed
• The highly absorbent central Hydrofiber™ pad absorbs and retains serosanguinous leakage and transforms into a soft gel, which maintains a moist environment to support the body’s healing process.
Under the supervision of a health care professional, AQUACEL® Ag Advantage SURGICAL cover dressings may be used for the management of surgical wounds as an effective barrier to bacterial penetration of the dressing, which may help reduce the risk of infection; and for surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic, vascular, ob/gyn, colorectal).
AQUACEL® Ag Advantage SURGICAL cover dressings 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) or those who are sensitive to or who have had an allergic reaction to colophony and its derivatives.
Sterility is guaranteed unless the pouch is damaged or opened prior to use. This device is for single use only and should not be reused. Reuse may lead to increased risk of infection or cross-contamination. Physical properties of the device may no longer be optimal.
Due to the sterilization process, there may be a slight odor on opening the primary packaging.
Do not apply the dressing under tension. It is not recommended to cut the dressing.
Choose a dressing size to ensure direct contact between the wound/incision and the Hydrofiber™ pad. The adhesive area should not come into contact with the wound/incision.
AQUACEL® Ag Advantage SURGICAL cover dressings are not designed as a replacement to primary closure methods such as staples or sutures.
Should infection develop during the use of the dressing, appropriate antibiotic therapy should be initiated. The use of AQUACEL® Ag Advantage SURGICAL cover dressings may be continued, but the progress of the wound/incision should be monitored carefully and all treatment should be under medical supervision.
The dressing is not compatible with oil-based products such as petrolatum.
While it has been observed that certain silver-containing products may cause skin discoloration following prolonged use, clinical studies with products containing Hydrofiber™ Technology with ionic silver have shown no such skin discoloration.
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.
AQUACEL® Ag Advantage SURGICAL cover dressings are 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.
The following adverse reactions have been identified during use of AQUACEL® Ag Advantage SURGICAL cover dressings or their components:
• 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 SURGICAL cover dressings 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.
This product is for single use only and is supplied sterile. If the inner package is damaged, do not use the dressing. Store at room temperature (10°C - 25°C/50°F- 77°F). Keep dry.
Non/Minimally Exudating Wound
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