Diagnosis of clinical infection of a wound

• US 7,794,925 B2
• Filed: 11/05/2002
• Issued: 09/14/2010
• Est. Priority Date: 11/05/2001
• Status: Expired due to Fees

• Current Assignee: Woundcheck Laboratories (US), Inc., Woundchek Laboratories (US), Inc.
• Original Assignee: Systagenix Wound Management (US), Inc.
• Inventors: Cullen, Breda Mary
• Primary Examiner(s): Lam; Ann Y
• Application Number:
  US10/494,507
• Publication Number:
  US 20050079542A1
• Time in Patent Office: 2,870 Days
• Field of Search: 436/518, 436514-517, 436/104, 436/548, 436/164, 436/800, 436/805, 435 4- 795, 4352831-2891, 422 50- 73, 356/4.01, 356/302, 356/303, 356/346
• US Class Current: 435/4
• CPC Class Codes: C12Q 1/37 involving peptidase or proteinase
• CPC Class Codes: G01N 2333/78 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: G01N 33/573 for enzymes or isoenzymes
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

A method of predicting or diagnosing clinical infection of a wound comprising measuring the concentration of a marker associated with an inflammatory response in wound fluid, wherein the marker is a fibronectin fragment, a neutrophil protease or a macrophage protease. Also provided is a use of a wound dressing or biosensor comprising components of an assay system for measuring the concentration of a marker associated with an inflammatory response, wherein the marker is a fibronectin fragment, a neutrophil protease or a macrophage protease, for use in the manufacture of a medicament for predicting the likelihood of clinical infection of the wound or for diagnosing clinical infection of a wound.

Claims

1. A method of predicting or diagnosing clinical infection of a chronic wound comprising measuring a concentration of a neutrophil elastase in wound fluid from the chronic wound, comparing the concentration to a basal level concentration of a neutrophil elastase, and determining if the concentration is at or above a level indicative of clinical infection or subsequent progression of the chronic wound to clinical infection;

wherein the concentration of the neutrophil elastase is measured by a dip-stick type test;

wherein a concentration from about 1.5-fold to about 16.0-fold the basal level concentration is indicative of clinical infection; and

wherein a concentration from about 1.5-fold to 9.0-fold the basal level concentration is indicative of subsequent progression to clinical infection.

2. The method according to claim 1 wherein the chronic wound is a chronic ulcer.

3. The method of claim 2 wherein the chronic ulcer is a dermal ulcer, venous ulcer, pressure sore, or decubitis ulcer.

4. The method according to claim 1 wherein the concentration of the neutrophil elastase is measured using an immunological, spectrophotometric, colorimetric, fluorimetric, or radioactive detection based technique.

5. The method of claim 1 wherein the measuring is performed on a sample of the wound fluid that has been removed from the body of a patient.

6. The method of claim 1 wherein the method is for predicting clinical infection of a chronic wound and determining if the concentration is at or above a level indicative of subsequent progression of the chronic wound from non-clinical to clinical infection.

7. The method according to claim 6 wherein the chronic wound is a chronic ulcer.

8. The method of claim 7 wherein the chronic ulcer is a dermal ulcer, venous ulcer, pressure sore, or decubitis ulcer.

9. The method according to claim 6 wherein the concentration of the neutrophil elastase is measured using an immunological, spectrophotometric, colorimetric, fluorometric, or radioactive detection based technique.

10. The method of claim 6 wherein the measuring is performed on a sample of the wound fluid that has been removed from the body of a patient.