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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764296
• Other study ID #: 56-RW-003
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: September 6, 2011
• Start date: December 2006

Study information

• Verified date: September 2011
• Source: Southwest Regional Wound Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wounds

Intervention

Other:
• no treatment
collection of samples of wound biofilm in Acute and Chronic Wounds
• no treatment
collection of samples for the evaluation of Wound Biofilm in Acute and Chronic Wounds

Locations

Country	Name	City	State
United States	Southwest Regional Wound Care Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Regional Wound Care Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No