Wound diagnosis by quantitating cortisol in wound fluids

• US 5,912,114 A
• Filed: 09/12/1997
• Issued: 06/15/1999
• Est. Priority Date: 09/12/1997
• Status: Expired due to Term

• Current Assignee: Woundchek Laboratories (US), Inc.
• Original Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Inventors: Swaniker, Hansen P., Hutchinson, Tyrone D.
• Primary Examiner(s): Saunders, David
• Assistant Examiner(s): VANDERVEGT, FRANCOIS P
• Application Number:
  US08/928,541
• Time in Patent Office: 641 Days
• Field of Search: 435/4, 435/7.1, 435/11, 436/817, 436/71, 436/131
• US Class Current: 435/4
• CPC Class Codes: G01N 33/743 Steroid hormones
• CPC Class Codes: Y10S 436/817 Steroids or hormones
• CPC Class Codes: Y10T 436/203332 Hydroxyl containing

Abstract

The present invention is directed to the diagnosis and assessment of wound status by quantitating levels of cortisol present in wound fluid. The present invention is also directed to a kit and test strip for assessing wound status.

Claims

1. A method for assisting the diagnosis of the status of wound healing in a patient comprising detecting cortisol levels in said wound.

2. The method of claim 1 wherein said diagnosis further comprises:

contacting wound fluid with an antibody reactive with cortisol for a time and under conditions sufficient to form an antigen-antibody complex, detecting and quantitating the antigen-antibody complex and comparing the amount of complex formed with normal plasma cortisol levels; and

correlating said cortisol levels with wound status.

3. The method according to claim 2, wherein said antibody is an anti-cortisol rabbit antibody.

4. The method according to claim 2, wherein said wound is a dermal ulcer, diabetic ulcer, a venous-stasis wound or a pressure sore.

7. The method of claim 2, further comprising contacting wound fluid with a test strip which comprises a support surface having disposed thereon an antibody bound to a reporter molecule operative in contact with wound fluid to develop a color indicative of cortisol.

5. A method to aid in detecting the status of wound healing comprising:

(a) contacting wound fluid with an antibody reactive with a cortisol for a time and under conditions sufficient to form an antigen-antibody complex and detecting the antigen-antibody complex;

(b) quantitating the amount of complex obtained from step (a);

(c) comparing the amount of complex obtained in step (b) with normal plasma cortisol levels, wherein an elevated level of cortisol compared to normal plasma cortisol levels correlates with an incompetent wound.

6. A method for detecting cortisol levels and correlating said levels with inflammation comprising:

(a) contacting wound fluid with an antibody reactive with a cortisol for a time and under conditions sufficient to form an antigen-antibody complex and detecting the antigen-antibody complex;

(b) quantitating the amount of complex obtained from step (a);

(c) comparing the amount of complex obtained in step (b) with normal plasma cortisol levels, wherein an elevated level of cortisol compared to normal plasma cortisol levels correlates with inflammation.

8. A method to aid in assessing a wound comprising:

(a) contacting wound fluid from the wound with an antibody reactive with cortisol for a time and under conditions sufficient to form an antigen-antibody complex and detecting the antigen-antibody complex;

(b) quantitating the amount of complex obtained from step (a);

(c) repeating steps (a) and (b) to determine the change in wound cortisol levels over time.

9. The method according to claim 8 wherein steps a-b are repeated within about three to about seven days.