Asdasd

BIOPATCH*
ANTIMICROBIAL DRESSING with Chlorhexidine Gluconate
INSTRUCTIONS FOR USE
(Please Read Carefully Before Using)
PRODUCT DESCRIPTION
BIOPATCH* Antimicrobial Dressing 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 bacterialgrowth
under the dressing.
Chlorhexidine Gluconate is a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity.
INDICATION FOR USE
BIOPATCH* Antimicrobial Dressing 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 percutaneousmedical devices such as:
IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally
inserted coronary catheters, mid-line catheter, 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 toCRBSI, in patients with central venous or arterial catheters.
PRECAUTIONS
BIOPATCH* Dressing should not be placed over infected wounds. It is not intended to be
used as a treatment of percutaneous device-related infections.
WARNING
WARNING: DO NOT USE BIOPATCH* DRESSING ON PREMATURE INFANTS. USE OF
THIS PRODUCT ON PREMATURE INFANTS HAS RESULTED IN HYPERSENSITIVITY
REACTIONS AND NECROSIS OFTHE 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* ANTIMICROBIAL DRESSING HAS
NOT BEEN ESTABLISHED IN CHILDREN UNDER 16 YEARS OF AGE.
DO NOT USE BIOPATCH* DRESSING ON PATIENTS WITH A KNOWN SENSITIVITY TO
CHLORHEXIDINE GLUCONATE. ADVERSE REACTIONS TO CHLORHEXIDINE GLUCONATE SUCH ASDERMATITIS, 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 CONTAININGCHLORHEXIDINE GLUCONATE, WHICH
WERE USED DURING URINARY TRACT PROCEDURES. PREPARATIONS OF THIS TYPE
ARE NOT APPROVED FOR SALE IN THE U.S. UNDER ANY CIRCUMSTANCES, CAUTION
SHOULD BE USED WHEN USING CHLORHEXIDINE-CONTAINING PREPARATIONS, AND
THE PATIENT SHOULD BE OBSERVED FOR THE POSSIBILITY OF HYPERSENSITIVITY
REACTIONS. THE GOVERNMENT OF JAPAN HAS REPORTED ANAPHYLACTOID-TYPE
ADVERSE EVENTS IN 13PATIENTS WHILE USING CENTRAL VENOUS CATHETERS
IMPREGNATED WITH CHLORHEXIDINE.
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.1 Results showed
that the use of BIOPATCH* Dressing resulted in a statistically significant 44% reduction
in the incidence of localinfection (p ≤ 0.0001).
Table 1: Summary of local infections in 1401 evaluable lines
No Local Infection
Local Infection
Total
# of lines (%)
# of lines (%)
BIOPATCH*
556 (83.6%)
109 (16.4%)
665
Control
520 (70.7%)
216 (29.3%)
736
Total
1076
325
1401
Results also showed that the use of BIOPATCH* Dressing resulted in a statistically
significant 60% reduction in the incidence ofcatheter-related blood stream infections
(p = 0.026).
Table 2: Summary of catheter-related blood stream infections (CRBSI)
in 589 evaluable subjects
No CRBSI
CRBSI †
Total
Frequency (%)
Frequency (%)
BIOPATCH*
288 (97.6%)
7 (2.4%)
295
Control
276 (93.9%)
18 (6.1%)
294
Total
564
25
589
† Clinical diagnosis based on positive blood cultures and DNA typing.
Results of this study...