Statseal Powder Specification Cover

Features

  • For temporary external control of bleeding from indwelling catheters and procedural sites
  • Versatile in that it fits a full range of catheter sizes and is ideal for sutured, large bore and extremely small catheters
  • Forms an instant seal over the insertion site to prevent oozing and bleeding
  • Creates a hostile barrier to microbial penetration over the site1
  • Does not rely on the clotting cascade thus works for patients prone to bleeding
  • Keeps sites dry and intact until the scheduled dressing change2-4
  • Reduces unplanned dressing changes and the associated infection risk2-4
  • Prophylactic use has been shown to reduce infection rates by as much as 92% when included in a CLABSI reduction strategy2

Product codes

CodeProduct
LP636StatSeal ® Powder – case of 24 applications

Rapid haemostasis to achieve dressing longevity: evaluation trial results using StatSeal catheter exit site protection

Angela Hastings and Andrew Barton.
British Journal of Nursing, 2024;33(14)

  • The trial’s aim was to evaluate the efficacy and safety of StatSeal for haemostasis following PICC line insertion
  • The primary endpoint was dressings that lasted 7 days
  • The clinical research was conducted by Frimley Health NHS Foundation trust
  • Of the StatSeal dressings, 99% lasted 7 days, whereas only 7% of the dressings without StatSeal lasted 7 days
  • The results of this study may indicate that StatSeal’s desiccant properties are also positively impacting common reasons for unplanned dressing change, including clammy skin and lack of dressing adherence

How it works

StatSeal products are comprised of a hydrophilic polymer and potassium ferrate. As a manual pressure adjunct, StatSeal’s mechanism of action is two-step and occurs simultaneously to instantly form a low pH occlusive seal that acts as a physical barrier over the wound site, letting nothing in or out. The hydrophilic polymer rapidly dehydrates the blood and absorbs exudate, stacking up desiccated blood solids beneath to form a seal. The potassium ferrate binds the blood solids and proteins together, adhering the seal to the wound to stop bleeding and oozing. Beneath the seal the pH is neutral, and the blood solids and proteins continue to stack naturally. Above the seal, the hydrophilic polymer has a pH of 2 which creates a hostile barrier to microbial penetration.1,3

References: [1] Biolife, LLC, 510(k) K080210, Section 18.3. [2] Wilder KA, Wall B, Haggard D, Epperson T. CLABSI Reduction Strategy: A Systematic Central Line Quality Improvement Initiative Integrating Line-Rounding Principles and a Team Approach. Adv Neonatal Care. 2016 Jun;16(3):170-7. [3] Blough L, Hinson K, Hen J. The science of a seal for PICC line management: bio seal CVC powder. J VAS Access. 2010;15(2):66-73. [4] Ayala, M. PICC Insertion Dressing Protocol for the Hematological Oncology Patient: A Comparison of Biopatch and StatSeal. Poster presented at AVA Annual Meeting; October 4-7, 2019; Las Vegas, NV.