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

Completed

Conditions studied: Wounds

In brief

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.

Key facts

Study ID

NCT00764296

Run by

Southwest Regional Wound Care Center

People needed

34

Starts

2006-12-01

Last updated by the study team

2011-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southwest Regional Wound Care Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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