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

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.

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Other: no treatment; Other: no treatment

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.

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Southwest Regional Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no treatment; The information obtained by the evaluation of both acute and chronic wounds is pivotal to truly understanding the intercellular tactics used by wound biofilms which work to disrupt host tissue and to evade the host's immune system.	Other: no treatment; collection of samples of wound biofilm in Acute and Chronic Wounds; Other: no treatment; collection of samples for the evaluation of Wound Biofilm in Acute and Chronic Wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Southwest Regional Wound Care Center

Study record dates

Study Major Dates

• Study Start: December 1, 2006

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: acute wounds and chronic wounds
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 56-RW-003