Page 55 - Journal of Special Operations Medicine - Fall 2014

Table 3 Animal Studies Using Third-Generation Chitosan-Based Hemostatic Dressings
Immediate Final Total
Author/Year Dressing Wound Model Hemostasis Hemostasis Blood Loss Survival Key Outcomes
Xie/2010 CG 6.0mm femoral punch; 25% 1180 ± 1370mL 63% (5/8) Eight per group; immediate hemostasis was defined as the percentage effective at first application; average time to achieve
45-sec free bleed; 3-min complete hemostasis was 12 min for CG and 3 min for HCG. ChitoGauze had greater success in achieving immediate
HCG direct compression; 63% 430 ± 1100mL 88% (7/8) hemorrhage control with less blood loss than Combat Gauze (p = .04) and favorable trends for much less total blood loss
180-min observation (p = .04) (p = .26) (p = .25) supporting the finding as reported by Schwartz et al. (2012). Conclusion: ChitoGauze has equal effectiveness as Combat
Gauze. Peer-reviewed abstract presented at the Advanced Technology Applications for Combat Casualty Care Conference,
St Petersburg, FL, August 2011; in press (2013).
™
Millner/2010 CEG Liver laceration; 83% (5/6) 100% (6/6) Thirty-eight gauze treatments in 13 swine; Omni-Stat (chitosan) applied from applicator and held in place with moist gauze;
coagulopathic swine with 2 min single layer of CEG placed on injured site and held in place; induced lacerations were repeated 1–3 times in the liver lobe
OS model; all agents were 100% (18/18) additional 1cm deeper to repeat application of agents. Both CEG and O-stat were more efficacious in hemostasis than SG (p < .001),
applied to injured pressure; SG but there was no significant difference between the two. They conclude that CEG and O-Stat have application for trauma
SG site held firmly for 7% (1/14) was not able surgery in short-term application in coagulopathic patients.
5 min; additional 2 min to provide
applied if needed. hemostasis with
added pressure.
Hoggarth/2011 6mm formal artery 38% (3/8) 50% 100% Eight in CG group and 12 in CR group; all animals survived. After wound packing with no compression, CG group had
punch; 45-sec free limited success, but for these animals in which bleeding continued after 2 min, compression was applied for 1 min in the
bleed; no compression 75% (9/12) 83% 100% CG group, resulting in 50% success. The CR group had 75% success without compression and then achieved 83% for
or after 2-min bleeding those cases needing 1-min compression. CR has potential for rapid packing and evacuation if needed without taking time
occurred then 1-min to hold compression. Peer-reviewed abstract presented at the Advanced Technology Applications for Combat Casualty Care
compression; adductor Conference, St Petersburg, FL, August 2011.
muscle was removed
over vessels; 120-min
observation period
Kunio/2011 6mm formal artery 83% (10/12) 31.9mL 100% CR significantly less post-treatment blood loss compared to other two agents (p = 0.02 vs. SG; p = 0.05 vs CG). CR is
punch; 60-sec free developed with no need to apply manual pressure once packed into wound. This agent is ideally targeted for potential
bleed; CUF scenario 100% (12/12) 12.8mL 100% Care Under Fire (CUF) scenarios or when the tactical situation dictates limited patient care opportunity. Additional studies
with no manual agent need to confirm effectiveness with ISR consensus wound. Peer-reviewed abstract presentation at the Advanced Technology
compression; adductor 83% (10/12) 44.7mL 100% Applications for Combat Casualty Care Conference, St Petersburg, FL. August 2011; in press 2013.
muscle not removed
over vessels; 120-min
observation period
Watters/2011 6mm femoral side-wall 50% (4/8) 374mL 100% Eight per group; study used CUF scenario—no manual compression applied after agent packed; no significant differences in
punch injury; 30-sec agent success or total blood loss (see trends across agents). Note: hemostatic agents are currently not recommended in CUF
free bleed; no adductor 75% (6/8) 205mL 100% phase in TCCC. Many limitations in this study because agents not used with manufacturer recommendation and no direct
muscle removed over pressure is applied. See Round Table Discussion reporting inconsistencies from studies by these authors when compared to
vessels; no direct 100% (8/8) 260mL 100% 22 of 23 studies over 15 years of research reported worldwide. Their wound model procedures are not consistent with the
pressure accepted US Army Institute of Surgical Research wound model as one explanation. Their techniques bring into question the
usefulness of their results across all hemostatic agents.
Rall et al./2013 CG 6.0mm femoral punch; 30% 60% 62 ± 65 60% Ten animals per group; IV fluids used to maintain MAP 60–65mmHg. Overall result trends favored CEG, but all agents were
45-sec free bleed; 3-min statistically as efficacious as CG in preserving survival. CEG outperformed all other dressings with 90% survival. Statistically
CGX manual pressure; 2.5-hr 80% 80% 32 ± 52 70% significant differences were found in initial hemostasis (CG vs. CGX, p = .02) and initial blood loss (CG vs. CGX, p = .026
max observation; mean and vs. CEG, p = .046). All study agents are FDA approved; These authors conclude that the standard of care agent (CG)
CTG arterial pressure kept at 30% 50% 65 ± 59 UKN should now be expanded to include CEG, CTG, and CGX agents.
60–65mmHg
CEG 70% 90% 29 ± 64 90%

HCG 60% 80% 40 ± 60 70%
(≈ mL/k)
Schwartz et CG 6.0mm femoral punch; 57% (4/7) 90% 1225 ± 1280mL 100% Seven animals per group; IV fluids used to return MAP to 65mmHg, then fluids discontinued; all result trends favored HCG
al./2012 45-sec free bleed; 2-min 32 ± 47 min over CG for total blood loss and quicker time to hemostasis, although this did not reach statistical significance. Authors
compression with conclude that ChitoGauze is equally efficacious as Combat Gauze in hemostatic properties. All agents are FDA approved.
HCG 75-lb plate; 180-min 71% (5/7) 100% 775 ± 714mL 100%
observation. 13 ± 28 min
Notes: Celox Gauze is significantly different from Celox Trauma Gauze. While Celox Trauma Gauze is made entirely from chitosan, Celox Gauze
is made of surgical gauze with chitosan coating. Celox Trauma Gauze is no longer manufactured.
CG, Combat Gauze; Combat Gauze XL, CGX; CEG, Celox Gauze; CR, Celox RAPID; CTG, Celox Trauma Gauze; HCG, HemCon ChitoGauze;
MAP, mean arterial pressure; FDA, US Food and Drug Administration; MR, manufacturer recommended; SG, standard gauze; OS, OmniStat.

Chitosan-Based Hemostatic Gauze Dressings 47