WoundsNCT00764348
Evaluation of Wound Biofilm in Acute and Chronic Wounds
An observational study of Wounds, run by Southwest Regional Wound Care Center.
Trial summary
Patients who present to a wound care center for management of their wounds will be evaluated clinically to establish if their wounds are chronic or acute. These patients will undergo standard of care management of their wounds. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento 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: Acute and Chronic Wounds
About this study
Patients who present to a wound care center for management of their wounds will be evaluated clinically to establish if their wounds are chronic or acute. These patients will undergo standard of care management of their wounds. If debridement is indicated for the patient, the patient will be asked to participate in a study. Once the standard of care debridement is complete, the material debrided from the wound, instead of being discarded into a biohazard bag, will be prepared for shipment. The samples will then be shipped to the Center for Biofilm Engineering where microscopic evaluation will be conducted on the material. Conclusion will be made from that analysis.
Read the detailed description
A planktonic concept of the bacteria present on the surface of a chronic wound is no longer viable. Microscopic studies show that biofilm is present on chronic wounds yet does not seem to be prominent on the surface of acute wounds. Biofilm is able to neutralize our host defenses and commandeer host systems, and possesses an impressive array of defenses and virulence factors. Clinically we see a significant difference in the healing behavior between chronic and acute wounds. Also, suppression of biofilm using multiple simultaneous strategies including debridement, anti-biofilm agents, specific biocides, antibiotics and advanced technologies improves wound healing. This suggests biofilm plays an important role in delayed wound healing.
- Conditions
- Wounds
- Being tested
- no treatment
- Keywords
- Acute 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
| Study group | Role | What they receive |
|---|---|---|
| no treatment | Not described Receives: Other: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is important for all wound care providers to firmly grasp the wound biofilm concept, its importance in delayed wound healing, and how it differs from a planktonic bacterial concept.
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)
Why it stopped: withdrawn as MSU approval obained
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
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT00764348
- Sponsor's protocol ID
- 56-RW-002
- Status last verified
- Sep 2011
- First submitted
- 30 Sep 2008
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
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
- Evaluation of Wound Biofilm in Acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT00764348
- Acronym / sponsor ID
- 56-RW-002
- Conditions
- Wounds
- Keywords
- Acute and Chronic Wounds
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: withdrawn as MSU approval obained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Southwest Regional Wound Care CenterUniversity, hospital or other
- 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.
Patients who present to a wound care center for management of their wounds will be evaluated clinically to establish if their wounds are chronic or acute. These patients will undergo standard of care management of their wounds. If debridement is indicated for the patient, the patient will be asked to participate in a study. Once the standard of care debridement is complete, the material debrided from the wound, instead of being discarded into a biohazard bag, will be prepared for shipment. The samples will then be shipped to the Center for Biofilm Engineering where microscopic evaluation will be conducted on the material. Conclusion will be made from that analysis.
Detailed description
A planktonic concept of the bacteria present on the surface of a chronic wound is no longer viable. Microscopic studies show that biofilm is present on chronic wounds yet does not seem to be prominent on the surface of acute wounds. Biofilm is able to neutralize our host defenses and commandeer host systems, and possesses an impressive array of defenses and virulence factors. Clinically we see a significant difference in the healing behavior between chronic and acute wounds. Also, suppression of biofilm using multiple simultaneous strategies including debridement, anti-biofilm agents, specific biocides, antibiotics and advanced technologies improves wound healing. This suggests biofilm plays an important role in delayed wound healing.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | Other: no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute and Chronic Wounds
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 treatment | Other | no treatment |
Primary outcome
It is important for all wound care providers to firmly grasp the wound biofilm concept, its importance in delayed wound healing, and how it differs from a planktonic bacterial concept.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by Southwest Regional Wound Care Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
It is important for all wound care providers to firmly grasp the wound biofilm concept, its importance in delayed wound healing, and how it differs from a planktonic bacterial concept.. 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; AzTrials last refreshed its copy on 8 Nov 2026.