The importance of hemostasis in chronic wound care. Snyder & Sigal

The importance of hemostasis in chronic wound care: an open-label controlled clinical study of OMNI-STAT (chitosan) versus standard of care in post-debridement treatment of patients with chronic wounds with or without concomitant use of anticoagulants.

Snyder RJ, Sigal BD. 

Wound Care Hyperb Medicine 2013; 4(2):9-16

 

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)

 

This article was first published in Wound Care & Hyperbaric Medicine Volume 4 Issue 2. The article is now available in downloadable PDF format.