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

Southwest Regional Wound Care Center1 site in 1 country34 target enrollmentDecember 2006

ConditionsWounds

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wounds
Sponsor: Southwest Regional Wound Care Center
Enrollment: 34
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 wounds.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Southwest Regional Wound Care Center

Responsible Party

Principal Investigator

Randall Wolcott

Prinicipal Investigator

Southwest Regional Wound Care Center

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

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.

Time Frame: 2 years