Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 17 for:    Necrotizing Fascitis

Outcome and Related Factors of Necrotizing Fasciitis of the Limb

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00538577
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Tracking Information
First Submitted Date September 30, 2007
First Posted Date October 2, 2007
Last Update Posted Date October 6, 2009
Study Start Date September 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00538577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcome and Related Factors of Necrotizing Fasciitis of the Limb
Official Title Not Provided
Brief Summary Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high morbidity and mortality rates. The purpose of this study is to determine the clinical manifestations and factors affected the treatment outcome to predict the prognosis and make timely decision for appropriate management and prevent limb loss.
Detailed Description Patients that are admitted to hospital with the diagnosis of necrotizing fasciitis of a limb will be entered to this study. A questionnaire will be completed for each patient included demographic data, admission and diagnosis date, treatment onset, medical history for diabetes mellitus, HIV infection, use of immunosuppressor drugs, peripheral vascular disease, cancer, renal disease, intravenous drug abuse, and disease outcome that can be recovery, amputation or death.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The Patients with diagnosis of necrotiying faciitis
Condition Necrotizing Fasciitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Estimated Enrollment
 (submitted: October¬†1,¬†2007)
25
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Necrotizing fasciitis of the limb
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00538577
Other Study ID Numbers 86-03-30-6110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chacellor of Research, Tehran University of Medical Sciences
Study Sponsor Tehran University of Medical Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Ramin Espandar, MD Imam Khomeini Hospital- Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date October 2009