D-Stat® Dry Topical Hemostat

Power of thrombin with the antimicrobal properties of silver

Thrombin is a powerful clotting agent and platelet aggregator which reduces time-to-hemostasis.1,2 Silver Topical Hemostat chloride (available in D-Stat® Dry Silver Topical Hemostat products only) is an active antimicrobial which prevents microorganisms from colonizing on the pad.

Clinical data to support a true hemostat

Results from a 376-patient, five-center, prospective randomized U.S. clinical study evaluating D-Stat® Dry Topical Hemostat as an adjunct to hemostasis in diagnostic femoral catheterizations using 4-6 Fr. introducer sheaths compared to standard manual compression (control).1,2

50% Reduction in Median Time-to-Hemostasis*

Time-To-Hemostasis (TTH) Results

D-Stat Dry Treatment Group (n=187)

Control Treatment Group (n=189)

Median TTH (mins)

6.0

12.0

Mean TTH (mins)**

7.8

13.0

± Standard Deviation

3.0

6.4

Range (min/max)

6, 22

6, 31

*Applicable to diagnostic procedures only.

**p-value of 0.001 calculated using Wilcoxon’s Signed-Rank Test

Hold Times and Ambulation Guidelines*

Medication Status

Puncture Size

Minimum Hold Time Recommendations3,4

Minimum Ambulation Recommendations4

Not anti-coagulated

4-6 Fr.

6 minutes

1.5-2.5 hours bed rest post sheath removal

Anti-coagulated5

4-6 Fr.

6 minutes

2.0-3.0 hours bed rest post sheath removal

*Applicable to diagnostic procedures only.

99.99% microbial kill rate6,7
D-Stat Dry® Silver Topical Hemostat demonstrated for seven microorganisms commonly encountered in the clinical setting, including MRSA, MRSE, and VRE


References:

  1. Hallak OK, Cubeddu RJ, Griffith RA, Reyes BJ.The use of the D-STAT dry bandage for the control of vascular access site bleeding: a multicenter experience in 376 patients. Cardiovasc Intervent Radiol. 2007;30(4):593-600
  2. This data is applicable to the D-Stat Dry Silver as non-clinical bench and in vivo animal testing has demonstrated similar hemostatic performance profiles for the D-Stat Dry and D-Stat Dry Silver products. Bench and animal testing results may not be indicative of clinical performance.
  3. D-Stat Dry is intended to be used as an adjunct to manual compression, and times reflect minimum uninterrupted hold times and are not an indication of actual times to hemostasis. Firm, non-occlusive compression should be applied for the first 1/2 of time, followed by gradually decreasing force until completion.
  4. The hold times and ambulation suggested are minimum guidelines based on a 376-patient randomized U.S. clinical trial. These guidelines should NOT supersede clinical judgment based on the medical condition of the individual patient.
  5. Includes an anti-clotting regime consisting of a single agent or combination of medications administered within 7 days of a diagnostic procedure. Medications include Heparin, LMWH, Coumadin, ASA and/or Plavix with an ACT ≤270.
  6. Antimicrobial efficacy was demonstrated against all cultures at 24 hours, including antibiotic resistant cultures. 
  7. Representative test samples from the D-Stat Silver product family (Dry, Wrap and Thrombix Silver) demonstrated an antimicrobial effect in these laboratory tests. Laboratory test results may not be indicative of clinical performance.
The D-Stat® Dry Topical Hemostat is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4–6 Fr. introducer sheaths. The D-Stat® Dry Silver Topical Hemostat is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry Silver® Topical Hemostat contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. The D-Stat® Dry Silver Topical Hemostat is contraindicated in persons with known sensitivity to bovine-derived materials.

WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS - THROMBIN-JMI® can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency. - Do not re-expose patients to THROMBIN-JMI® if there are known or suspected antibodies to bovine thrombin and/or factor V. - Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.

Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Not all products are available in all regions. Please contact customer service to confirm availability in your region. THROMBIN-JMI is a registered trademark of King Pharmaceuticals Research and Development, LLC. Teleflex, the Teleflex logo and D-Stat are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. MC-004465 Rev 0 Revised: 08/2018.