Evaluation of Wound Biofilm in Acute and Chronic Wounds
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 30, 2008 |
| Last Updated Date | September 6, 2011 |
| Start Date ICMJE | Not Provided |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE |
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. [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00764348 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Evaluation of Wound Biofilm in Acute and Chronic Wounds |
| Official Title ICMJE | Evaluation of Wound Biofilm in Acute and Chronic Wounds |
| Brief 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. 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 Type ICMJE | Observational |
| Study Design ICMJE | Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Retention: Samples With DNA Description: traumatic, diabetic foot ulcer, decubitus ulcer, venous leg ulcer |
| Sampling Method | Non-Probability Sample |
| Study Population | Acute and Chronic Wounds |
| Condition ICMJE | Wounds |
| Intervention ICMJE | Other: no treatment |
| Study Group/Cohort (s) | no treatment
Intervention: Other: no treatment |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Withdrawn |
| Enrollment ICMJE | 0 |
| Completion Date | Not Provided |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Not Provided |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT00764348 |
| Other Study ID Numbers ICMJE | 56-RW-002 |
| Has Data Monitoring Committee | No |
| Responsible Party | Randall Wolcott, Southwest Regional Wound Care Center |
| Study Sponsor ICMJE | Southwest Regional Wound Care Center |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Southwest Regional Wound Care Center |
| Verification Date | September 2011 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|