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

NCT ID: NCT00764296

Last Updated: 2011-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Wounds

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

no treatment

Intervention Type OTHER

collection of samples of wound biofilm in Acute and Chronic Wounds

no treatment

Intervention Type OTHER

collection of samples for the evaluation of Wound Biofilm in Acute and Chronic Wounds

Interventions

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no treatment

collection of samples of wound biofilm in Acute and Chronic Wounds

Intervention Type OTHER

no treatment

collection of samples for the evaluation of Wound Biofilm in Acute and Chronic Wounds

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Regional Wound Care Center

OTHER

Sponsor Role lead

Responsible Party

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Randall Wolcott

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southwest Regional Wound Care Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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56-RW-003

Identifier Type: -

Identifier Source: org_study_id

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