Page 59 - Journal of Special Operations Medicine - Fall 2014

the wound was no longer bleeding and had no evidence room for pack removal and euthanization. The need for
of infection. repacking of the liver was assessed, and tissue samples
were collected from the liver edge and adjacent small
In the case report by Schmid et al., a 32-year-old woman bowel for histopathology. The investigators reported
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underwent an elective cesarean delivery at a gestational that compared with gauze, the blood loss at 10 minutes
age of 37 weeks for complete placenta previa. During was significantly lower in Celox granules and ACS+ (P =
the procedure, the placenta was delivered by manual 0.001). At 48 hours, a total of 27.3% of control animals
removal without difficulty. There was no evidence of died compared with 18.2% of Celox-treated animals
placenta accreta. Two hours after the uneventfully com- and 0% of ACS+–treated animals. All gauze- and ACS+–
pleted initial surgery, heavy vaginal bleeding was ob- treated animals required repacking to control bleeding,
served, which was treated with additional oxytocin and compared with one of the Celox granule–treated animals
sulprostone infusion and manual compression. Because at the 48-hour evaluation. There was no difference be-
control of severe postpartum bleeding was not achieved, tween groups in the extent of tissue necrosis.
they chose to perform tight uterovaginal packing with
Celox Gauze. Hemostasis was achieved, and the Celox In the second study, Inaba et al. extended the long-term
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Gauze was left in the uterus for 36 hours. The patient application of the hemostatic agents using both second-
was coagulopathic and required 10U of packed red and third-generation hemostatic dressings for efficacy
cells, 7U of plasma, and 2g fibrinogen. Postoperatively, and safety. The investigators examined Combat Gauze
the patient made a good recovery. No further bleeding (kaolin), Celox Gauze (chitosan), and Celox granules
occurred after removal of the Celox Gauze. Addition- (chitosan) hemostatic dressings against standard packing
ally, Schmid et al. reported a case series using Celox gauze for hemorrhage control up to 14-day survival in
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Gauze for 24 to 30 hours in 19 patients with postpar- a damage-control swine model of Grade IV liver injury
tum hemorrhage due to uterine atony, placenta accreta/ (off-label internal use). Blood loss at 15 minutes was sig-
increta, or coagulopathy, including 5 severe cases where nificantly lower in the Celox granules and Combat Gauze
a hysterectomy seemed inevitable otherwise. In all but groups (p = .002). Forty-eight-hour survival was 50.0%
one case, the bleeding stopped and further surgical in- for standard gauze, 58.3% for Combat Gauze, 83.3%
terventions were avoided. for Celox granules, and 41.7% for Celox gauze groups
(p = .161). Fourteen-day survival was not statistically dif-
ferent among groups: 41.7% for standard gauze, 50.0%
Internal Application
for Combat Gauze, 58.3% for Celox granules, and
Two studies by Inaba and colleagues (2011, 2013) are 41.7% for Celox Gauze groups (p = .821). After long-
very applicable to military operational contingencies in term evaluations of efficacy and safety at 48 hours and 14
worldwide remote locations where prolonged (12–72 days, they noted that there was no histological difference
hours) care of casualties by forward deployed surgical among treatment groups in the depth of necrosis of the
teams will be necessary with prolonged patient hold- liver or small bowel in direct contact with the hemostatic
ing before available medical evacuation to Role 2 or 3 dressings. However, for both the Celox granules and Ce-
medical treatment facility. 70,71 In the first study, Inaba et lox Gauze groups, all animals had macroscopic evidence
al. reported the first hemorrhage control study that has of adhesions. Based on a 14-day application, these adhe-
70
examined short- and long-term application of second- sions may have led to several deaths attributed to bowel
generation hemostatic agents for efficacy and safety. obstruction in four animals in the Celox granules group
These series of animal studies evaluated the extension and two in the Combat Gauze group. This was most pro-
of external application of hemostatic products into in- nounced in the animals treated with Celox granules be-
ternal (off-label) use. A 48-hour damage-control model cause the powdered agent became dispersed throughout
of Grade IV liver injury was developed and used to test the peritoneal cavity during the 14 days, most likely due
Celox granules (chitosan) and QuikClot ACS+ (zeolite) to daily upright animal movement, which is in contrast to
against standard liver packing (gauze). Anesthetized human patients. One death in the standard gauze group
pigs had a controlled 35% total blood volume bleed. was caused by sepsis; the remainder of deaths was caused
The liver was injured, and after 2 minutes of uncon- by blood loss. No distal emboli were found with either
trolled hemorrhage, the animals were randomized to Combat Gauze or Celox Gauze, but one animal in the
receive application of standard gauze control (gauze), Celox granule group had material in the coronary ves-
Celox, or QuikClot ACS+ and packed in a standard- sels. However, no complications or negative outcomes oc-
ized manner. At 10 minutes, the packs were removed to curred in either of the two gauze groups.
calculate the amount of shed blood. The animals then
underwent damage control closure with dressing packed Next, Muzzi et al. reported that a 59-year-old man pre-
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in place. Forty-eight hours after initial damage control sented for the treatment of acute type A dissection with
packing, the animals were returned to the operating type B right coronary artery involvement. The patient

Chitosan-Based Hemostatic Gauze Dressings 51