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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00764296
First received: September 30, 2008
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Wounds
Other: no treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds

Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

The debridement sample will be processed to extract DNA for 16s rDNA evaluation in order to determine the microbial population of the sample using a more sensitive means than standard culture.


Enrollment: 34
Study Start Date: December 2006
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764296

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Randall Wolcott, Prinicipal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT00764296     History of Changes
Other Study ID Numbers: 56-RW-003
Study First Received: September 30, 2008
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
acute wounds and chronic wounds

ClinicalTrials.gov processed this record on October 16, 2014