Johnson & Johnson Biopatch Antimicrobial Dressing
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BIOPATCH Protective Disk with CHG - the #1 selling CHG dressing on the market with a 1A CDC recommendation
Product DescriptionBIOPATCH Protective Disk with CHG is a hydrophilic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG). The foam material absorbs up to eight times its own weight in fluid, while the CHG incorporated into the dressing inhibits bacterial growth under the dressing.Chlorhexidine Gluconate is a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity.
Indication For Use
BIOPATCH containing Chlorhexidine Gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheters, drains, chest tubes, externally placed orthopedic pins, and epidural catheters. It is also intended to reduce local infections, catheter-related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.PrecautionsBIOPATCH should not be placed over infected wounds. It is not intended to be used as a treatment of percutaneous device-related infections.
DO NOT USE BIOPATCH ON PREMATURE INFANTS. USE OF THIS PRODUCT ON PREMATURE INFANTS HAS RESULTED IN HYPERSENSITIVITY REACTIONS AND NECROSIS OF THE SKIN.FOR EXTERNAL USE ONLY. DO NOT ALLOW THIS PRODUCT TO CONTACT THE EYES, EARS, MOUTH, OR MUCOUS MEMBRANES.THE SAFETY AND EFFECTIVENESS OF BIOPATCH HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 16 YEARS OF AGE.DO NOT USE BIOPATCH DIRECTLY OVER BURN INJURY OR ON PATIENTS WITH A KNOWN SENSITIVITY TO CHLORHEXIDINE GLUCONATE. ADVERSE REACTIONS TO CHLORHEXIDINE GLUCONATE SUCH AS DERMATITIS, HYPERSENSITIVITY, AND GENERALIZED ALLERGIC REACTIONS ARE VERY RARE, BUT IF ANY SUCH REACTIONS OCCUR, DISCONTINUE USE OF THE DRESSING IMMEDIATELY.HYPERSENSITIVITY REACTIONS ASSOCIATED WITH THE TOPICAL USE OF CHLORHEXIDINE GLUCONATE HAVE BEEN REPORTED IN SEVERAL COUNTRIES. THE MOST SERIOUS REACTIONS [INCLUDING ANAPHYLAXIS] HAVE OCCURRED IN PATIENTS TREATED WITH LUBRICANTS CONTAINING CHLORHEXIDINE GLUCONATE, WHICH WERE USED DURING URINARY TRACT PROCEDURES. PREPARATIONS OF THIS TYPE ARE NOT APPROVED FOR SALE IN THE U.S. UNDER ANY CIRCUMSTANCES.
Clinical Trial Results
A controlled, randomized, clinical trial consisting of 687 subjects with 1699 central venous or arterial catheter insertion sites was conducted at two centers.1Results showed that the use of BIOPATCH resulted in a statistically significant 44% reduction in the incidence of local infection (p≤0.0001).Results also showed that the use of BIOPATCH resulted in a statistically significant 60% reduction in the incidence of catheter-related blood stream infections (p=0.026). Results of this study also showed that use of BIOPATCH resulted in statistically significant reduction in skin colonization of microorganisms commonly associated with CRBSI (p≤0.05). Patients randomized to the BIOPATCH Treatment Group experienced no serious device-related adverse events.Information regarding the use of BIOPATCH on patients <16 years of age is limited. A study performed on 16 patients, ages 3 days to 15 years, was performed to evaluate the effectiveness of BIOPATCH in the management of insertion or exit sites of indwelling CVCs. No cases of catheter-related infections were reported during the course of the trial. Compared to the institution?s standard therapy, BIOPATCH resulted in better appearance of entrance/exit sites in 56% of cases (p=0.002); less irritation of entrance/exit sites in 50% of cases (p=0.011); better entrance/exit site protection in 94% of cases (p<0.001). BIOPATCH was the preference of the investigators over standard therapy in 81% of cases (p<0.001).1Maki DG, Mermel L, Genthner D, Hua S, Chiacchierini RP: An evaluation of BIOPATCH Antimicrobial Dressing compared to routine standard of care in the prevention of catheter-related blood stream infection. Ethicon, Inc. 2000
Directions For Use
- Prepare the skin surrounding the percutaneous device according to hospital protocol.
- Remove BIOPATCH from the sterile package using aseptic technique
- Place BIOPATCH around the device, making sure the BLUE PRINTED side is facing upward. The WHITE foam side releases the Chlorhexidine Gluconate (CHG) and should be in contact with the patient?s skin.
- In order to ensure easy removal when used with a film dressing, place BIOPATCH around the device site in such a way that the device rests upon the slit portion of the BIOPATCH. The edges of the radial slit must be pushed together and remain in contact to maximize efficacy.
- Secure the device and BIOPATCH to the skin. Ensure complete contact between the skin and BIOPATCH.
- Change the patch as necessary, in accordance with facility protocol; dressing changes should occur at a minimum of every 7 days. Dressing changes will be needed more frequently with highly exuding wounds.
- To remove the transparent film dressing, pick up the corner of the dressing and stretch the dressing away from the device, holding the device in place. (Dressing will partially lift.) Peel back until resistance is felt. Repeatedly stretch and peel as necessary until the dressing is removed.
- BIOPATCH will remain attached to the transparent film dressing, so removal will be simultaneous
- The product warranty is applicable as per the terms and conditions provided by the product manufacturer.
Please call us for specific details.
- No returns will be accepted after 30 days from the date of shipment.
- All returns are subject to a restocking fee as per manufacturers terms and conditions.
- All returns must have an RGA number (Returned Goods Authorization), unauthorized returns will not be accepted.
- We do not guarantee fulfillment of any desired purpose or product suitability to the user and this will not be considered as a valid reason for return.
- The products must be new, unused condition, not tampered with, in original packaging and returned at the customers expense in the original packaging.
- If your return is not due to any manufacturing defect then the original shipping cost will be deducted from the total refund.
- Hygiene, bath and toilet items cannot be returned once opened or used.
- Standard manufacturer terms and conditions apply for return policy of this product.
Please call us for specific details.