Skip to main content
×
×
Home

Evaluation of Skin Damage from Accidental Removal of a Hemostatic Wound Clamp (The iTClamp)

  • Jessica L. Mckee (a1), Prasanna Lakshminarasimhan (a1), Ian Atkinson (a1), Anthony J. LaPorta (a2) and Andrew W. Kirkpatrick (a3) (a4) (a5)...
Abstract
Background

Controlling bleeding early in the prehospital and military setting is an extremely important and life-saving skill. Wound clamping is a newly introduced technique that may augment both the effectiveness and logistics of wound packing with any gauze product. As these devices may be inadvertently removed, the potential consequences of such were examined in a simulated, extreme, inadvertent disengagement.

Methods

The wound clamp used was an iTClamp (Innovative Trauma Care; Edmonton, Alberta, Canada) that was applied and forcefully removed (skin-pull) from the skin of both a human cadaver and swine. Sixty skin-pull tests were sequentially performed to measure the pull weight required to remove the device, any potential skin and device damage, how the device failed, and if the device could be re-applied.

Results

Observations of the skin revealed that other than the expected eight small needle holes from device application, no other damage to the skin was sustained in 98.3% of cases. Conversely, of the 60 devices pulled, 93.3% of the devices sustained no damage and all could be re-applied. Four (6.7%) of the devices remained in place despite a maximum pull weight >22lb F (pound-force). The mean pull weights for pin bar pull were (lb F ): vertical 9.2 (SD=5.0); perpendicular 2.5 (SD=1.7); and parallel 5.3 (SD=3.1). For the encompassed pull position group, mean pull weights were (lb F ): vertical 5.7 (SD=2.3); perpendicular 3.0 (SD=2.5); and parallel 14.5 (SD=3.5). The overall mean for all groups was 6.7 (SD=5.2). The two main reasons that the iTClamp was pulled off were because the friction lock let go or the needles slipped out of one side of the skin due to the angle of the pull.

Conclusion

Inadvertent, forcible removal of the iTClamp created essentially no skin damage seen when the wound clamp was forcibly removed from either cadaver or swine models in a variety of positions and directions. Thus, the risks of deployment in operational environments do not seem to be increased.

Mckee JL , Lakshminarasimhan P , Atkinson I , LaPorta AJ , Kirkpatrick AW . Evaluation of Skin Damage from Accidental Removal of a Hemostatic Wound Clamp (The iTClamp). Prehosp Disaster Med. 2017;32(6):651656.

Copyright
Corresponding author
Correspondence: Jessica Mckee, BA, MSc Director, Clinical Alberta Innovates R&D Industry Associate Innovative Trauma Care Suite 343, 6556-28 Ave NW Edmonton, Alberta, Canada T6L 6N3 E-mail: jmckee@itraumacare.com
Footnotes
Hide All

Conflicts of interest/funding/disclaimer: Jessica Mckee is the Clinical Director of Innovative Trauma Care (Edmonton, Alberta, Canada), the company that funded this study and manufactures and distributes the iTClamp, one of the devices tested in this study. Jessica Mckee has had her travel covered by Innovative Trauma Care as part of her position with the company and is entitled to stock options. Prasanna Lakshminarasimhan was the technical engineer of Innovative Trauma Care. Ian Atkinson is the Chief Technical Officer of Innovative Trauma Care. Ian Atkinson also sits on the board for Innovative Trauma Care, is entitled to stock options, and is on several patents with the company. Innovative Trauma Care has also covered Ian Atkinson’s travel when it is related to his employment with the company. Major Andrew W. Kirkpatrick has been paid a consulting fee and travel compensation from Innovative Trauma Care. Andrew Kirkpatrick has also consulted for Acelity (San Antonio, Texas USA) and Cook Medical (Bloomington, Indiana USA); Cook Medical has also paid for his travel on other projects. Dr. Anthony LaPorta declares that he has no conflict of interest. This study was funded by Innovative Trauma Care. There is no grant or funding number. The opinions expressed are solely the opinions of the authors and do not represent any official positions or policies of any agencies or departments of the Governments of Canada or the United States of America.

Footnotes
References
Hide All
1. Champion, HR. Epidemiological basis for future improvements in trauma care. Seminars in Hematology. 2004;41(Suppl 1):173.
2. Eastridge, BJ, Mabry, RL, Seguin, P, et al. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012;73(6 Suppl 5):S431-S437.
3. Stussman, BJ. National Hospital Ambulatory Medical Care Survey: 1994 emergency department summary. Adv Data. 1996;275:1-20.
4. Grissom, TE, Fang, R. Topical hemostatic agents and dressings in the prehospital setting. Curr Opin Anaesthesiol. 2015;28(2):210-216.
5. Kragh, JF, Lunati, MP, Kharod, CU, et al. Assessment of groin application of junctional tourniquets in a manikin model. Prehosp Disaster Med. 2016;31(4):358-363.
6. Bulger, EM, Snyder, D, Schoelles, K, et al. An evidence-based prehospital guideline for external hemorrhage control: American College of Surgeons Committee on Trauma. Prehosp Emerg Care. 2014;18(2):163-173.
7. Butler, FK Jr., Holcomb, JB, Giebner, SD, McSwain, NE, Bagian, J. Tactical combat casualty care 2007: evolving concepts and battlefield experience. Mil Med. 2007;172(11 Suppl):1-19.
8. Kheirabadi, B. Evaluation of topical hemostatic agents for combat wound treatment. US Army Med Dep J. 2011: 25-37.
9. Filips, D, Logsetty, S, Tan, J, Atkinson, I, Mottet, K. The iTClamp controls junctional bleeding in a lethal swine exsanguination model. Prehosp Emerg Care. 2013;17(4):526-532.
10. Mottet, K, Filips, D, Logsetty, S, Atkinson, I. Evaluation of the iTClamp 50 in a human cadaver model of severe compressible bleeding. J Trauma Acute Care Surg. 2014;76(3):791-797.
11. Thompson, L. Application of the iTClamp in the management of hemorrhage: a case study. Journal of Paramedic Practice. 2014;6(5):180-181.
12. Hudson, A GW. First UK use of the iTClamp hemorrhage control system: case report. Trauma. 2014;16(3):214-216.
13. St John, AE, Wang, X, Lim, EB, Chien, D, Stern, SA, White, NJ. Effects of rapid wound sealing on survival and blood loss in a swine model of lethal junctional arterial hemorrhage. J Trauma Acute Care Surg. 2015;79(2):256-262.
14. Bennett, BL, Littlejohn, L. Review of new topical hemostatic dressings for combat casualty care. Mil Med. 2014;179(5):497-514.
15. Littlejohn, LF, Devlin, JJ, Kircher, SS, Lueken, R, Melia, MR, Johnson, AS. Comparison of Celox-A, ChitoFlex, WoundStat, and combat gauze hemostatic agents versus standard gauze dressing in control of hemorrhage in a swine model of penetrating trauma. Acad Emerg Med. 2011;18(4):340-350.
16. Barnung, S, Steinmetz, J. A prehospital use of ITClamp for hemostatic control and fixation of a chest tube. Acta Anaesthesiol Scand. 2014;58(2):251-253.
17. Beckett, A, Savage, E, Pannell, D, Acharya, S, Kirkpatrick, A, Tien, HC. Needle decompression for tension pneumothorax in Tactical Combat Casualty Care: do catheters placed in the midaxillary line kink more often than those in the midclavicular line? J Trauma. 2011;71(5 Suppl 1):S408-S412.
18. Grange, JT, Corbett, SW. Violence against emergency medical services personnel. Prehosp Emerg Care. 2002;6(2):186-190.
19. Corbett, SW, Grange, JT, Thomas, TL. Exposure of prehospital care providers to violence. Prehosp Emerg Care. 1998;2(2):127-131.
20. Pozzi, C. Exposure of prehospital providers to violence and abuse. J Emerg Nurs. 1998;24(4):320-323.
21. Currier, GW. Atypical antipsychotic medications in the psychiatric emergency service. J Clin Psychiatry. 2000;61(Suppl 14):21-26.
22. Baker, SN. Management of acute agitation in the emergency department. Adv Emerg Nurs J. 2012;34(4):306-318; quiz 319-320.
23. Weiss, S, Peterson, K, Cheney, P, Froman, P, Ernst, A, Campbell, M. The use of chemical restraints reduces agitation in patients transported by emergency medical services. J Emerg Med. 2012;43(5):820-828.
24. LaPorta, A KA, Mckee, J, Roberts, D, et al. Randomized control trial comparing marksmanship following application of a tourniquet or hemostatic clamp in healthy volunteers. Royal Army Medical Corps. In Press.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Prehospital and Disaster Medicine
  • ISSN: 1049-023X
  • EISSN: 1945-1938
  • URL: /core/journals/prehospital-and-disaster-medicine
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords

Metrics

Altmetric attention score