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OpenTrials
Completed

NCT Number: NCT00764296

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment

Other

collection of samples of wound biofilm in Acute and Chronic Wounds

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.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Southwest Regional Wound Care Center

Other

Registry information

Important dates

Study start
2006
First posted
Oct 2, 2008
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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