OMNI-STAT® - Evidence

Section key points

  • Significant level of evidence supporting OMNI-STAT® as an effective hemostat
  • Laboratory studies show rapid clot formation in normal and coagulation-deficient blood, and in hypothermic blood
  • OMNI-STAT® is an effective hemostat in a number of pre-clinical models of uncontrolled bleeding and bleeding in presence of some anticoagulant drugs (Medtrade data on file)
  • Clinically, OMNI-STAT® has been shown to be an effective hemostat in wound debridement, traumatic and coagulopathic bleeding in presence of some anticoagulant drugs (Medtrade data on file)
  • OMNI-STAT® could provide cost-saving benefits

Data

1. In Vitro Studies

Standardized laboratory studies have been used to show the effectiveness of OMNI-STAT® as a hemostatic dressing. The blood clotting time was tested with freshly drawn blood. 20 minutes after the addition of OMNI-STAT® to the blood a good clot had formed. When the time at which the blood had clotted was assessed, OMNI-STAT® significantly reduced the clotting time compared with the control tests (31 seconds vs. 817 seconds, respectively)  (Johnson et al, 2008).

Blood clots after 20 minutes (Johnson et al, 2008)

Studies examining the hemostatic effect of the chitosan derived dressing on coagulation of anticoagulant treated blood showed that hemostasis is largely unaffected by the presence of anticoagulants. Whereas anticoagulant treated blood showed significant delays in coagulation in the standard laboratory tests, the presence of chitosan derived material led to coagulation times similar to those seen in the non anticoagulant treated blood. In this model the heparinised blood clotted in 48s and warfarinised blood in <30s when in contact with OMNI-STAT granules. (Johnson et al, 2008).

Anticoagulant treated blood clotting times (Johnson et al, 2008)

OMNI-STAT® was able to clot freshly drawn heparinized blood that has been cooled to a temperature of 56°F. The mean clotting time for the OMNI-STAT® treated blood was 20 seconds, whereas control blood failed to clot within the 10 minute test period (data on file).

Performance of OMNI-STAT® in hypothermic blood

2. Clinical Evaluations - Wound Debridement

The presence of devitalized tissue in wounds may impair the healing process and removal of this tissue promotes wound healing (Saap and Falanga, 2002). The removal of devitalized tissue can be achieved by debridement and sharp debridement removes this necrotic tissue down to the level of well-vascularized tissue (Fife et al, 2012). Sharp debridement can increase the risk of bleeding and this risk is exacerbated by the use of anticoagulants in the aging population where chronic wounds are particularly prevalent. Clinical evaluations have been reported demonstrating positive outcomes of using OMNI-STAT® in providing effective hemostasis after sharp debridement, including patients receiving anticoagulants.

Open-label, controlled evaluation (n=40) evaluating chronic wounds of varying etiology with or without
concomitant use of anticoagulants.

Snyder and Sigal (2013) reported on the results of an open-label, controlled clinical investigation designed to evaluate the hemostatic properties of the chitosan-impregnated gauze, OMNI-STAT®, in patients with open wounds of various aetiologies (including diabetic foot ulcer and venous leg ulcer) post-debridement. Forty patients were recruited into the study (n=20, OMNI-STAT®; n=20, standard of care). Both groups included a large proportion of patients on anticoagulant therapy (15/20 OMNI-STAT®, 16/20 control). After debridement, excess blood was wiped away and the wound was then treated with the OMNI-STAT® or the control gauze followed by pressure for 2 minutes. The dressings were left in place for 7 days and then removed at a follow-up visit after being saturated with saline for five minutes. The primary endpoint in the study was the time required to achieve hemostasis with secondary endpoints being an assessment of the patient’s pain levels at the start and end of the treatment and an assessment of the wound bed.

Time to hemostasis (minutes) (Snyder and Sigal, 2013)

The mean time hemostasis in the OMNI-STAT® treated group was 1 minute 19 seconds compared with 5 minutes and 19 seconds for the control group (p<0.0001). The quality of the granulation tissue of the wound after 1 week was significantly improved in the OMNI-STAT® treated group (OMNI-STAT® group: 18/20 improved, none deteriorated; control group: none improved, 4/20 deteriorated; p<0.05). Pain scores in the OMNI-STAT® group were consistently lower compared with the control group upon application, during application and on dressing removal after one week. The authors conclude that, as well as promoting hemostasis leading to reduced treatment time, the OMNI-STAT® provided a moist wound environment and improved the quality of the wound granulation tissue. The establishment of a moist environment may be due to the absorbent nature of the chitosan granules component of OMNI-STAT®. The authors suggest that the use of chitosan-impregnated hemostatic dressings may lead to an alteration in clinical practice, allowing for the rapid control of bleeding after wound debridement in patients with chronic wounds despite the prevalence of anticoagulants.

Tissue quality after 1 week (Snyder and Sigal, 2013)

 

3. Uncontrolled Hemorrhage

OMNI-STAT® Clinical and Scientific Monograph

4. Coagulopathic Bleeding

OMNI-STAT® Clinical and Scientific Monograph


References

Please click here to view a list of references.

 

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