Field Experience with a Chitosan-Based Haemostatic
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6-Seiter Sonderdruck Form-01 15.08.2011 10:56 Uhr Seite 1 Reprint from MCIF 3. /4-2011 Reprint from MCIF 3./4 -2011 E. C. T. H. TAN, C. P. BLEEKER (NETHERLANDS) Field experience with a chitosan-based haemostatic dressing B Uncontrolled hemorrhage is the leading cause of death among combat casualties A and is the second major cause of death in civilian trauma patients. Major impro- vements have been made in the deve- lopment of novel dressings with D haemostatic properties to control heavy bleeding in non-compressible areas. We describe the use of chitosan gauze (Celox GauzeTM), a chitosan-based hae- mostatic agent for the control of massive traumatic bleeding in 7 patients. C Introduction Fig. 9: A CeloxTM Gauze; B ChitoGauzeTM; C HemCon®; D QuikClot® Gauze (previously Combat Gauze). Bleeding remains a leading cause of death in trauma patients, both in civilian Table 2: Overview of a number of haemostatic dressings (prices October 2010 in the Netherlands). and military settings. Military experience in Vietnam, Iraq and Afghanistan has led Fig. 1: Lifeliner 3’s mobile medical team in action during an operation. Product Material Cost in € Effective- Shelf Side Use Weight Regis- Website to the introduction of the Combat Appli- (excl. VAT) ness life effects tration International importer cation Tourniquet (CAT-T®)(1) to treat haemostatic dressing in the field based on tracted from shrimp, cross react with red Dutch distributor severe bleeding from the extremities and BATLS 2006 JSP (57). Many comparative blood cells and form a solid clot, regard- Celox Chitosan 43,50 + 3 yr None USA, Singapore, 57 gram FDA + http://www.celoxmedical.com/ haemostatic dressings for severe bleeding animal studies 1-8 and case series 9-12 less of the natural clotting mechanism of Gauze Germany, Poland, CE+ index.htm from extremities, head, neck and torso. have been written on the use of haemosta- the body. In addition, chitosan absorbs Czech Republic, http://www.innoventa.nl/medisch- Meanwhile, several NATO countries have tic dressings. water, one of the main components of Malaysia, Italy, Mex- eerste-hulp/celox.html equipped their troops with haemostatic Chitosan gauze is a new haemostat blood, allowing the natural clotting fac- ico, Chile. dressings and included the use of different based on the polysaccharide chitosan. It is tors to become more concentrated, pro- QuickClot Kaolin 32,50 + 3 yr Does not USA, Canada, 30 gram FDA + http://www.z-medica.com/ protocols, such as the TCCC (Tactical derived from chitin, a complex carbohy- moting activation of the body's clotting Gauze resorb, Poland, Germany, CE+ http://www.specialmedics.com/nl/ Combat Casualty Care) guidelines of drate which occurs in the exoskeleton of mechanism. The function of chitosan is (Combat must be Slovakia, Italy, products.php?group=2&product=8 November 2009 and the BATLS (Battlefield crustaceans such as shrimps. Among other not affected by external factors such as Gauze) removed Turkey, Denmark, Advanced Trauma Life Support) guide- factors that promote the reaction with the body temperature (hypothermia or heat) Netherlands (DSI lines. Since 2009 the Royal Netherlands blood, chitosan contains small positively and works in heparinised patients and and special forces) Army have used HemCon® as their charged particles. These particles, ex- patients using aspirin. Chitosan causes no (TCCC guideline) Hemcon Chitosan 179,00 + 3 yr None USA, Canada, Aus- 14 gram FDA + http://www.hemcon.com/ Les hémorragies non contrôlées sont La hemorragia no controlada es la Also antimi- tralia, Israel, UK, CE+ la cause principale de décès parmi principal causa de muerte entre http://www.renesmit.com/ les blessés de guerre et constituent los heridos en combate, y la crobial effect Netherlands, Ger- la deuxième cause principale de segunda causa de muerte en los many, Austria, Italy, décès chez les patients traumatisés pacientes civiles con trauma. Se civils. Des améliorations considérab- han realizado importantes mejo- Poland, South les ont été effectuées dans le déve- ras en el desarrollo de novedosos Africa. (in BATLS loppement de nouveaux équipe- apósitos con propiedades hemos- ments ayant des propriétés táticas para controlar sangrados guideline). hémostatiques pour contrôler les importantes en áreas no compre- Do not fold. saignements importants dans les sibles. Describimos el uso de + zones non compressibles. Nous la gasa de chitosan (Celox Chito- Chitosan 44,55 also antimi- 3 yr None USA, Israel, UK, 32 gram FDA + décrivons l’utilisation de la gaze au GauzeTM), un agente hemostático http://www.hemcon.com/ chitosane (Celox GauzeTM), un agent con base de chitosan para el con- Gauze crobial effect Netherlands http://www.renesmit.com/ hémostatique à base de chitosane trol de la hemorragia traumática pour le contrôle des saignements masiva en 7 pacientes. massifs traumatiques chez 7 patients. 5 MCIF 3./4-2011 6-Seiter Sonderdruck Form-01 15.08.2011 10:57 Uhr Seite 2 Reprint from MCIF 3./4 -2011 Reprint from MCIF 3./4 -2011 exothermic reaction and is not toxic. After and partly stopped bleeding in the nose a gauze bandage. The haemostatic band- be brought near to the source of bleeding. The ideal haemostatic dressing needs no use the wound is easily rinsed with saline. and ears. Although the haemorrhage ages with chitosan are CeloxTM Gauze (Fig. One option could be an applicator with training to use, does not decay, is flexible Chitosan is available in granular form and seemed to reduce, leaking continued in 9A), currently on the market and Chito- chitosan beads. In patient 6, it remains and cheap, attaches only to the bleeding impregnated in gauze. We describe our the hospital. Additional studies using a CT GauzeTM(2) (Fig. 9B), the successor to Hem- debatable whether the tamponade effect wound, has no side effects, has no risk of experience in seven patients using the scan showed a fractured skull. Con® (HemCon is a kind of thick parch- came from the abdominal gauze pads. We infection has no effect on wound healing new chitosan gauze (CeloxTM Gauze(3)). The last four patients were treated dur- ment, which is difficult to conform mould advice to use a haemostat in a dressing and effectively stops arterial, venous and ing our deployment in the Dutch Role 2E into wounds) (Fig. 9C). An antibacterial format, given the “natural” and “known” soft tissue bleeding. In our view, chitosan- TM Materials and methods in Uruzgan,the Uruzgan Medical Center, effect is claimed for ChitoGauze . It is use (as opposed to an applicator or bag of based haemostatic dressings fulfil these Afghanistan (Fig. 2). slightly more expensive than CeloxTM loose beads or the thicker parchment criteria. We conclude that chitosan-based For the past six months we have imple- Patient 4 was an Afghan wounded by a Gauze (see Table 2). There are case series HemCon®) for stopping bleeding. haemostatic dressings are a safe and useful mented chitosan gauze, pre-hospital, dur- roadside bomb. He had several blast describing the use of Celox in The working group for military surgery tool in stopping or controlling external ing our work on Lifeliner 3 (one of the injuries including a tear wound in his left Fig. 3: Care for patient 4 with shrapnel Fig. 4: Groin wound by patient 4 from Afghanistan, also use in surgery. In addi- of the Royal Netherlands Army was asked blood loss in our series of patients. Future four Dutch trauma helicopters, stationed groin (Fig. 3). An emergency bandage was injury from a roadside bomb. shrapnel injury treated with chitosan tion there is QuikClot® Combat Gauze(2) to give an advice on the use of haemosta- clinical studies should be conducted to at Volkel Airbase, falling within the applied in the field. On arrival at the bandages. (Fig. 9D), with the active ingredient tic dressings within the military. A small identify the ideal haemostatic dressing. ■ Regional Emergency Healthcare Network, emergency room there was fresh blood kaolin, the successor to QuikClot ACS + ™ subgroup of the military surgery working and the Radboud University Nijmegen leaking through the dressing. At the emer- (zeolite). This is now available without group, consisting of physician Colonel References with the autor Medical Centre), and during our deploy- gency room we applied chitosan gauze to exothermic reaction (see Table 2 for Teun van Egmond, MD, Major Oscar van ment in August and September 2010 to the wound, with pressure for a few min- review). The authors intend to carry out Waes, MD and the first author, formulated This article has been published previously the Dutch Role 2E at Camp Holland in the utes, after which the injury stopped bleed- further clinical testing on all of the above an advisory opinion to the Emergency in the Netherlands Military Medical Review provence of Uruzgan, Afghanistan. Indica- ing. Also in the operating room, about ten dressings. Medical Advisory Group at the end of 2011, 64, p 45-49, and has been reproduced tions were bleedings that could not be minutes later, the wound was still not The authors are aware that these cases 2009. This opinion is based on literature with consent of the Netherlands Military controlled with an “ordinary” compressive bleeding (Fig. 4). In the operating room, are purely observational and descriptive review, interviews with representatives Medical Review bandage. In total, seven patients were the various injuries were cleaned and a and there are many confounding vari- and their own experience with haemosta- treated with chitosan gauze: three patients small arterial bleed in the groin was iden- ables, as well as lack of long-term follow- tic bandages and was approved by the Notes: pre-hospital on the Lifeliner 3 and four tified (lesser tributary of the superficial up. Although no adverse reactions were above military surgeons.