Safety of the long-term application of QuikClot Combat Gauze, ChitoGauze PRO and Celox Gauze in a femoral artery injury model in swine – a preliminary study

Abstract

The purpose of this study was to examine the safety of the long-term application of QuikClot Combat Gauze, ChitoGauze PRO and Celox Gauze using a swine model. The study was conducted on nine pigs weighing approximately 30 kg, which were randomly divided into three groups. Under deep anesthesia, the pigs underwent complete transverse cutting of the femoral artery in the groin region. Hemostatic dressings were left in the wound for 24 hours. The animals were euthanized 24 hours after dressing application. In each group, macroscopic and microscopic severe changes and shock symptoms were observed in the lungs, liver, kidneys and heart. Fibrino-gaseous embolic material was found in the pulmonary artery of each group and in the lung vessels of the animals from the ChitoGauze PRO and Celox Gauze groups. In conclusion, the long-term application of the evaluated hemostatic dressings has the risk of coagulopathy and reaching the progressive stage of shock. The residues from the hemostatic dressings can ingress into the systemic circulation, thereby increasing the risk of embolus formation. Because of these harmful effects, the evaluated hemostatic dressings are not appropriate for long-term use. Future studies are needed on the consequences of the long-term application of these hemostatic agents.

CaCO3–Chitosan Composites Granules for Instant Hemostasis and Wound Healing

“…In hospitals, hemorrhage causes 15–25% of trauma deaths. A lot of hemostatic materials are used for hemorrhage controlling [ 3 , 4 ], which can be divided into inorganic materials [ 5 , 6 , 7 ] and organic polymer materials [ 8 ]. Inorganic materials include WoundStat, QuikClot, and Combat Gauze and polymer materials include Celox, Celox-D, HemCon, which are all commercially available products for hemostatic wound healing.…”

Hemostatic agents for prehospital hemorrhage control: a narrative review

“…Safety concerns have also been raised for some local hemostatic agents [30,31]. A recent survey indicated that hemostatic agents were infrequently utilized to manage traumatic hemorrhage during the recent conflicts in Afghanistan and Iraq [137].…”

“…Despite these great successes, there are safety concerns with the prehospital or in-combat use of local hemostatic agents [30,135,205]. Although no adverse events have been reported in human studies with the use of Combat Gauze, HemCon, Celox Gauze, Celox granules, ChitoGauze and QuikClot ACS+ [54,204], these studies are relatively short-term observational studies.…”

“…Animal studies raised concerns with the presence of intraluminal particles and thrombi as well as tissue damage 2 to 3 h after treatment when WoundStat, super quick relief (another mineral-based hemostat composed of potassium iron oxyacid salt and hydrophilic polymer) and Celox were compared against HemCon, QuikClot ACS+ and Combat Gauze [31,220]. Otrocka-Domagała et al [30] observed macroscopic and microscopic severe changes and shock symptoms in the lungs, liver, kidneys and heart and fibrino-gaseous embolic material in the pulmonary artery and in the lung vessels 24 h after treatment with Combat Gauze, ChitoGauze and Celox Gauze in a femoral artery injury model in swine. The risk of the transmission of infectious agents may be another problem associated with the application of biological hemostatic agents [221].…”

“…These include self-propelling particles [25], hydrophobically modified chitosan gauze [26], injectable and in situ forming gels [27,28], and self-expanding foams [29]. Given the safety concerns with some currently used hemostatic materials [30,31], more efficient and safer hemostatic agents are still needed.…”