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

Published online by Cambridge University Press:  24 August 2017

Jessica L. Mckee ,
Prasanna Lakshminarasimhan ,
Ian Atkinson ,
Anthony J. LaPorta  and
Andrew W. Kirkpatrick
Jessica L. Mckee*
Affiliation:
Innovative Trauma Care, Edmonton, Alberta, Canada
Prasanna Lakshminarasimhan
Affiliation:
Innovative Trauma Care, Edmonton, Alberta, Canada
Ian Atkinson
Affiliation:
Innovative Trauma Care, Edmonton, Alberta, Canada
Anthony J. LaPorta
Affiliation:
Professor of Surgery and Military Medicine, Rocky Vista School of Medicine, Parker, ColoradoUSA
Andrew W. Kirkpatrick
Affiliation:
Regional Trauma Services and the Departments of Surgery, Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada Canadian Forces Health Services, Canada Alberta Health Services, Foothills Medical Centre, Calgary, Alberta, Canada
*
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
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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 >22lbF (pound-force). The mean pull weights for pin bar pull were (lbF): 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 (lbF): 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.

MckeeJL, LakshminarasimhanP, AtkinsonI, LaPortaAJ, KirkpatrickAW. Evaluation of Skin Damage from Accidental Removal of a Hemostatic Wound Clamp (The iTClamp). Prehosp Disaster Med. 2017;32(6):651–656.

Keywords

hemorrhage controliTClampskin damage
Type
Original Research
Information
Prehospital and Disaster Medicine , Volume 32 , Issue 6 , December 2017 , pp. 651 - 656
Copyright
© World Association for Disaster and Emergency Medicine 2017 

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Footnotes

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.

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