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NCT00764348 Clinical Trial

Evaluation of Wound Biofilm in Acute and Chronic Wounds

Wounds Clinical Trial

Official title:
Evaluation of Wound Biofilm in Acute and Chronic Wounds

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00764348
Other study ID # 56-RW-002
Secondary ID
Status Withdrawn
Phase N/A
First received September 30, 2008
Last updated September 6, 2011

Study information
Verified date September 2011
Source Southwest Regional Wound Care Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• no treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Southwest Regional Wound Care Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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. No
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