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Status:

COMPLETED

Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds

Lead Sponsor:

Southwest Regional Wound Care Center

Conditions:

Wounds

Eligibility:

All Genders

18+ years

Brief Summary

The Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.

Detailed Description

Characterizing the surface of the acute wound is important because the characterization can act as a control and can give a standard by which to judge the microscopic pathology observed in chronic wou...

Eligibility Criteria

Inclusion

  • The subject must be 18 years of age or older.
  • The subject must have a full thickness acute or chronic wound. The sampling is restricted to subjects with the presence of a full thickness wound in order to reduce any risk for infection to the subject. Biopsying a wound that is already full thickness should not increase the subject's risk.
  • The subject must have no history of coagulopathy
  • If the subject's acute wound will be biopsied, the wound must be less than 48 hours old.
  • The subject must be a candidate for sharp debridement

Exclusion

  • The subject may not have myelosuppression indicated by a CBC which may include a WBC less than 1500 cells per cubic millimeter, platelet count less than 125,000 per cubic millimeter, or hemoglobin less than 9 g/dL.
  • The subject may not be on anticoagulation therapy because anticoagulation therapy increases the risk of bleeding.
  • The subject may not have a TCpO2 less than 20 torr. Subjects with low tissue oxygenations may have some risk from biopsy due to their poor ability to heal and, therefore, are excluded.
  • The subject may not be pregnant
  • The subject's wound must not be in the region of the face, neck, or genitalia

Key Trial Info

Start Date :

December 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00764296

Start Date

December 1 2006

Last Update

September 7 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Southwest Regional Wound Care Center

Lubbock, Texas, United States, 79410