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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00764296

Enrollment

Registered

2008-10-02

Start date

2006-12-31

Completion date

Unknown

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Keywords

acute wounds and chronic wounds

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.

Interventions

OTHERno treatment

collection of samples of wound biofilm in Acute and Chronic Wounds

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026