A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Randall Wolcott, Southwest Regional Wound Care Center

ClinicalTrials.gov Identifier:

NCT01089673

First received: March 17, 2010

Last updated: September 6, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 17, 2010
Last Updated Date	September 6, 2011
Start Date ^ICMJE	March 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 17, 2010)	A retrospective molecular diagnostic review on wound care outcomes between two time periods. [ Time Frame: The time periods include June, July, August of 2008 and June, July, August of 2009. ] [ Designated as safety issue: No ] The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01089673 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	A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes
Official Title ^ICMJE	A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes
Brief Summary	A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patient records would be extracted from the electronic health record system of Southwest Regional Wound Care Center.
Condition ^ICMJE	Wounds
Intervention ^ICMJE	Other: data collection retrospective data collection
Study Group/Cohort (s)	no treatment retrospective data analysis Intervention: Other: data collection
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	Completed
Estimated Enrollment ^ICMJE	600
Completion Date	September 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: A patient record captured during June, July, August 2008 and June, July, or August of 2009. Exclusion Criteria: A patient record captured outside the time frame of June, July August 2008 or June, July, August of 2009.
Gender	Both
Ages	Not Provided
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	NCT01089673
Other Study ID Numbers ^ICMJE	56-RW-016
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

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