Skip to main content

Advertisement

SpringerLink
Log in

Hemostasis and Safety of a Novel Fibrin Dressing Versus Standard Gauze in Bleeding Cancellous Bone in a Caprine Spine Surgery Model

  • Case Series
  • Published:
Spine Deformity Aims and scope Submit manuscript

Abstract

Background

Decorticated bone is a significant source of blood loss in scoliosis surgery. Current hemostatic methods include packed gauze (GS), physical barriers such as bone wax, and xenograft collagen-based materials. We assessed the safety and efficacy of a novel fibrin dressing (dextran-thrombin-fibrinogen [DTF]) compared to GS. This dressing comprises lyophilized thrombin and fibrinogen embedded in an elastic electrospun nanofiber dextran matrix.

Purpose

The study tests the hypothesis that DTF is more efficacious than GS in control of bleeding from cancellous bone.

Study Design

A preclinical Good Laboratory Practices (GLP) study.

Methods

We enrolled 10 goats that were followed for 28 ± 1 days. Each animal was randomly assigned to the test or control group. Both test and control animals had 4 cancellous bone injuries. Test animal injuries were treated with DTF, whereas standard GS was used to control bleeding in the control animals. Bleeding at the bone injury site was characterized as either none, oozing, flowing, or pulsatile and was assessed at 4 and 8 minutes after dressing application. Goats were survived 28 ± 1 days and then necropsied.

Results

Application of the fibrin dressing to bleeding cancellous bone, both posterior spinal lamina, and iliac crest graft sites, resulted in control of bleeding within 4 minutes at all injury sites. Eighty percent of control injury sites continued to bleed after 8 minutes and required application of bone wax to control bleeding. There were no differences in prothrombin time, partial thromboplastin time, or fibrinogen levels between test and control animals at 1 or 28 days. We observed no adverse histologic reactions at 28 days.

Conclusion

The fibrin dressing is an efficacious and safe method of controlling blood loss from cancellous bone in a spine surgery model.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. McNeill TW, DeWald RL, Kuo KN, et al. Controlled hypotensive anesthesia in scoliosis surgery. J Bone Joint Surg Am 1974;56:1167–72.

    Article  CAS  Google Scholar 

  2. Cheriyan T, Maier SP, Bianco K, et al. Efficacy of tranexamic acid on surgical bleeding in spine surgery: a meta-analysis. Spine J 2015;15:752–61.

    Article  Google Scholar 

  3. Abbott EM, Nandyala SV, Schwend RM. Does a kaolin-impregnated hemostatic dressing reduce intraoperative blood loss and blood transfusions in pediatric spinal deformity surgery? Spine 2014;39:E1174–80.

    Article  Google Scholar 

  4. Price JS, Tackett S, Patel V. Observational evaluation of outcomes and resource utilization from hemostatic matrices in spine surgery. J Med Econ 2015:1-10.

  5. Wu J, Jin Y, Zhang J, et al. Hemostatic techniques following multilevel posterior lumbar spine surgery: a randomized control trial. J Spinal Disord Tech 2014;27:442–6.

    Article  Google Scholar 

  6. Epstein NE. Tisseel does not reduce postoperative drainage, length of stay, and transfusion requirements for lumbar laminectomy with non-instrumented fusion versus laminectomy alone. Surg Neurol Int 2015;6:S172–6.

    Article  Google Scholar 

  7. Colombo GL, Bettoni D, Di Matteo S, et al. Economic and outcomes consequences of Tachosil®: a systematic review. Vasc Health Risk Manage 2014;10:569–76.

    Article  CAS  Google Scholar 

  8. Rothwell SW, Reid TJ, Dorsey J, et al. A salmon thrombin-fibrin bandage controls arterial bleeding in a swine aortotomy model. J Trauma 2005;59:143–9.

    Article  CAS  Google Scholar 

  9. Floyd CT, Rothwell SW, Martin R, et al. A salmon thrombin-fibrinogen dressing controls hemorrhage in a swine model compared to standard kaolin-coated gauze. J Spec Oper Med 2012;12:49–55.

    PubMed  Google Scholar 

  10. Floyd CT, Rothwell SW, Risdahl J, et al. N. Salmon thrombin-fibrinogen dressing allows greater survival and preserves distal blood flow compared to standard kaolin gauze in coagulopathic swine with a standardized lethal femoral artery injury. J Spec Oper Med 2012;12:16–26.

    PubMed  Google Scholar 

  11. Padua RA, Olson CE, Rothwell RS, Floyd CT. Performance of a dextran-only dressing versus SurgiClot to achieve hemostasis in a swine injury model of cancellous bone bleeding. Paper presented at: Orthopaedic Research Society Annual Meeting 2016.

  12. Bayne K. Revised Guide for the Care and Use of Laboratory Animals available. American Physiological Society. Physiologist 1996;39:199.208-11.

    CAS  PubMed  Google Scholar 

  13. US Food and Drug Administration web site, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=58. Accessed June 17, 2015.

  14. Virzi R. Refining the test phase of usability evaluation: how many subjects is enough? Hum Factors 1992;34:457–68.

    Article  Google Scholar 

  15. Rothwell SW, Sawyer E, Dorsey J, et al. Wound healing and the immune response in swine treated with a hemostatic bandage composed of salmon thrombin and fibrinogen. J Mater Sci Mater Med 2009;20:2155–66.

    Article  CAS  Google Scholar 

  16. Rothwell SW, Settle T, Wallace S, et al. The long term immunological response of swine after two exposures to a salmon thrombin and fibrinogen hemostatic bandage. Biologicals 2010;38:619–28.

    Article  CAS  Google Scholar 

  17. Padua RA, Olson CE, Floyd CT. Resorption characteristics of a novel fibrin hemostatic dressing. Paper presented at: Accepted, Orthopaedic Research Society Annual Meeting 2016.

  18. Kheirabadi BS, Mace JE, Terrazas IB, et al. Clot-inducing minerals versus plasma protein dressing for topical treatment of external bleeding in the presence of coagulopathy. J Trauma 2010;69:1062–72.

    Article  CAS  Google Scholar 

  19. Kim DH, Chun YS, Vaccaro AR, et al. Complications of iliac crest: bone graft harvesting. In: An HS, Jenis LG, editors. Complications of spine surgery: treatment and prevention. Philadelphia, PA: Lippincott Williams & Wilkins; 2006. p. 143–52.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. St. Teresa Medical, Inc., 1075 North Curtis Road, Suite 101, Boise, ID, 83706, USA

    C. Timothy Floyd MD, Rodolfo A. Padua PhD & Curtis E. Olson PhD

Authors
  1. C. Timothy Floyd MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Rodolfo A. Padua PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Curtis E. Olson PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to C. Timothy Floyd MD.

Additional information

Author disclosures

CTF (other from St. Teresa Medical, Inc., during the conduct of the study; personal fees from St. Teresa Medical, Inc., outside the submitted work); RAP (other from St. Teresa Medical, Inc, outside the submitted work); CEO (other from St. Teresa Medical, Inc, outside the submitted work).

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Floyd, C.T., Padua, R.A. & Olson, C.E. Hemostasis and Safety of a Novel Fibrin Dressing Versus Standard Gauze in Bleeding Cancellous Bone in a Caprine Spine Surgery Model. Spine Deform 5, 310–313 (2017). https://doi.org/10.1016/j.jspd.2017.03.003

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1016/j.jspd.2017.03.003

Keywords

Search

Navigation