Clinical Information

The following is a partial itemization of independent third party and company sponsored research trials and case studies summarizing various performance parameters of the powder in human and animal applications. The title of the investigation, author(s), and results summary follow:

Vascular Access

Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures; Journal of Vascular and Interventional Radiology. Vol. 19, Number 1, January 2008.

Authors: David S. Wang, MD, Larry F. Chu, MD, Scott E. Olson, MD, Frank J. Miller, MD, Karim Valji, MD, Wade H. Wong, DO, Steven C. Rose, MD, Matthew Austin, MD, Michael D. Kuo, MD.

Conclusion – Summary:

  • (StatSeal) is proven to achieve hemostasis in less than two minutes for venous access and four minutes for arterial procedures based on results from a randomized controlled clinical study.
  • All three agents effectively reduced time to hemostasis with minimal associated complications. (StatSeal) is superior to D-Stat in reducing time to hemostasis and was found to be more effective in all four procedure types.

The Science of a “Seal” for PICC Line Management: BIOSEAL CVC (StatSeal) Powder As An Alternative Hemostatic Agent That Keeps Sites Dry And Intact,” Journal of the Association for Vascular Access, Summer 2010, 15:2, 66-73.

Authors: Lauren Blough, RN, BS, CRNI, Kathy Hinson, BS, RN, MN, MPH, MBA, John Hen, PhD.

Conclusion – Summary:

  • Showed a 40% decrease in Catheter-Related Bloodstream Infections (CRBSIs) during and post-trial.
  • Eliminated the 48-hour dressing change; initial dressing change performed at 7 days.
  • Achieved fast hemostasis, even for patients with clotting difficulties (≤ 2 min. in 96% of applications).
  • Resulted in no reported complications.

Expert Summary Report – A GLP Preclinical Study Evaluating Hemostasis Efficacy and Safety Using PRO QR Advanced Formula Powder (StatSeal) in the Swine Model. December 17, 2008.

Authors: Daniel E. McLain, PhD, CNS, DABFE, President and Consulting Toxicologist, Walker Downey & Associates, Inc., Verona, WI 53593 USA.

Conclusion – Summary:

  • Percutaneous access of the cephalic vein and femoral artery of Sus scrofa, followed by standard manual sterile gauze compression (i.e., the standard-of-care) or treatment with (StatSeal) with reduced manual pressure time, showed improved time-to-hemostasis for both vascular sites with (StatSeal).
  • The test article was deemed easy to use by the testing laboratory. Results support the safety and efficacy of StatSeal for application at vascular access sites, with tissue distribution remaining local (i.e., predominantly at the catheter exit site). No adverse or otherwise untoward effects would be anticipated with clinical use.

Trauma

 Comparison of a Novel Hemostatic Agent to Currently Available Agents in a Swine Model of Lethal Arterial Extremity Hemorrhage: Advanced Technology Applications for Combat Casualty Care Poster Presentation: Conference 2007.

Authors: Xu Wang MD, Violeta Yordanova DVM, Jeffrey Li BS, Michael Tupper MD, John Younger MD, Susan Stern MD, University of Michigan, Department of Emergency Medicine, Ann Arbor, MI 48109.

Conclusion – Summary:

  • In a clinically relevant model of lethal arterial hemorrhage, the application of the new hemostatic agent, (StatSeal), significantly reduced mortality, hemorrhage volume, and resuscitation requirements as compared to all other hemostatic agents tested in this study. Additionally, (StatSeal) did not result in the marked increase in tissue temperature characteristic of zeolite-based products.

Woundcare

 Comparative Efficacy and Safety Results of Topical Hemostatic Powder and Sterile Compressed Foam Sponge in Second Intention Healing Following Mohs Micrographic Surgery: Journal of Drugs in Dermatology, March 8, 2009.

Authors: Leon Kircik, MD – Clinical Associate Professor of Dermatology, Indiana University, Indianapolis, IN and Director, Physicians Skin Care, PLLC, Louisville, KY James Q. Del Rosso, DO, Dermatology Residency Director, Valley Hospital Medical Center, Las Vegas, NV, Clinical Associate, Professor (Dermatology), University of Nevada School of Medicine, Las Vegas, NV and Touro University College of Osteopathic Medicine, Henderson, NV, and Las Vegas Skin & Cancer Clinics, Las Vegas, NV and Henderson, NV.

Conclusion – Summary:

  • Comparative global assessments of (StatSeal) showed greater efficacy and more rapid onset of action in second intention wound healing
  • (StatSeal) tended to reduce erythema and it produced less scarring. There was also a trend towards a more rapid reduction in wound size with the (StatSeal). No peeling, ulceration, infection, or necrosis was noted in either group. By week 12, neither group had pigmentary changes. Subject-reported itching and burning trended slightly higher in Group II while pain was greater in Group I, although not significantly so.

Novel Management of Wound Dehiscence: Case Study; The American Journal of Cosmetic Surgery. Vol. 25, Number 3: March 10, 2008.

Author: David N. Michelson, MD, Medical Director of the Cosmetic Aesthetic Anti-Aging Medical Center Inc. Thousand Oaks, CA.

Conclusion – Summary:

  • The action of (StatSeal) in the promotion of tissue granulation, prevention of infection and the increasing epithelialization compared favorably to traditional methods of treating surgical wound dehiscence.
  • (StatSeal) effectively absorbs exudates and the seal fosters a moist environment to promote healing.
  • (StatSeal) is a safer and more cost-effective solution than surgical closure for wound dehiscence.
  • (StatSeal) is easy to use and allows patients to take an active role in their treatment.

Additional Clinical Info

Fast, Effective Hemostasis for Minor to Traumatic Bleeding Wounds

  • 96% success rate treating lacerations, skin tears and abrasions with 70% stopping in less than 15 seconds.*
  • Stops severe hemorrhage in only four minutes in a swine study of a lethal arterial femoral 6mm punch biopsy. StatSeal significantly reduced mortalityStatSeal Powder on wound, hemorrhage volume and resuscitation requirements as compared to all other tested agents.

University of Michigan, Dept. of Emergency Medicine Study – Comparison of a Novel Hemostatic Agent to Currently Available Agents in a Swine Model of Lethal Arterial Extremity Hemorrhage, Susan Stern

Rapid Hemostasis for Vascular Access Procedures

In a peer-reviewed clinical trial comparing the efficacy of two compression adjuncts in 176 percutaneous vascular access procedures, StatSeal (formerly PRO QR/BioSeal) was twice as fast in achieving hemostasis as the control with no differences in infections or adverse events.

Procedure Type
StatSeal TTH (min.)
Control TTH (min.)
Time Saved (min.)
Venous 1.93 3.96 2.0
Arteriovenous Dialysis Access 3.41 7.26 3.8

†Wang DS, Chu LF, Olson SE, Miller FJ, Valji K, Wong WH, Rose SC, Austin M, Kuo MD. Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures. Journal of Vascular and Interventional Radiology January 2008; 19: 72-79.

Forms a Seal Over Wounds and Around Catheters

In a 39-day trial of StatSeal Powder (formerly PRO QR and BioSeal CVC) for all PICC insertions (418) and occasional bleeding during dressing changes or line discontinuations at a large Florida hospital showed:

  • Time to Hemostasis (TTH) was <= 2 min. in 94% of applications
  • TTH for patients with clotting difficulties was <= 2 min. in 96% of applications
  • The 48-hour dressing change was eliminated; initial dressing change performed at 7 days
  • No reported complications

The Science of a “Seal” for PICC Line Management: BIOSEAL CVC Powder As An Alternative Hemostatic Agent That Keeps Sites Dry And Intact,” Journal of the Association for Vascular Access, Summer 2010, 15:2, 66-73. Author: Lauren Blough, RN, BS, CRNI, Kathy Hinson, BS, RN, MN, MPH, MBA, John Hen, PhD

Provides Greater Patient Outcomes

  •  In a study of Mohs Micrographic Surgery, StatSeal Powder showed greater efficacy and more rapid onset of action in second intention healing compared with the control compressed foam sponge (at week 12). StatSeal reduced erythema and produced fewer incidents of scarring.

Journal of Drugs in Dermatology (JDD), February 2010, Vol. 9, Issue 2: 137-140, Leon Kircik, MD and James Q. DelRosso, DO.

  • In a case study of plastic surgery, StatSeal Powder was shown to be an effective treatment for wound dehiscence. The powder encouraged the epithelialization and granulation of the wound, helped to control exudates and kept the wound free of infection.

“Novel Management of Wound Dehiscence: Case Study”, The American Journal of Cosmetic Surgery, Vol. 25, 3: 152-156., David N. Michelson, MD

*Studies on file at Biolife