WoundsNCT00764296
Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds
An observational study of Wounds, run by Southwest Regional Wound Care Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- no treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
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.
Read the 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.
- Conditions
- Wounds
- Being tested
- no treatment
- Keywords
- acute wounds and chronic wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no treatmentOther
collection of samples of wound biofilm in Acute and Chronic Wounds
no treatmentOther
collection of samples for the evaluation of Wound Biofilm in Acute and Chronic Wounds
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Regional Wound Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Wolcott, Southwest Regional Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764296
- Sponsor's protocol ID
- 56-RW-003
- Status last verified
- Sep 2011
- First submitted
- 30 Sep 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT00764296
- Acronym / sponsor ID
- 56-RW-003
- Conditions
- Wounds
- Keywords
- acute wounds and chronic wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- Study start
- Dec 2006
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | Other: no treatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no treatmentcollection of samples of wound biofilm in Acute and Chronic Wounds | Other | no treatment |
| no treatmentcollection of samples for the evaluation of Wound Biofilm in Acute and Chronic Wounds | Other | no treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by Southwest Regional Wound Care Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.