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

NCT00764296 | Completed DMC

• 1 other identifier: 56-RW-003
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

acute wounds and chronic wounds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

no treatment OTHER

collection of samples of wound biofilm in Acute and Chronic Wounds

no treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest Regional Wound Care Center: lead

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

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.

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: December 1, 2006
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

US (1)