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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03443544
Other study ID # UR16-00003
Secondary ID
Status Completed
Phase N/A
First received February 12, 2018
Last updated February 22, 2018
Start date November 1, 2017
Est. completion date February 1, 2018

Study information

Verified date February 2018
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

Fournier's gangrene it's a necrotizing infection of the genital area, with high morbidity and mortality. The site of infection its the origin of the necrotizing fasciitis. There are 4 well known origins of Fournier's gangrene: Testicular, Intestinal, Urinary and cutaneous, and its prognostic value has not been established yet, that's because the lack of case series with adequate number of patients. This is a retrospective study in which we evaluate the prognostic factors of every patient and its mortality compared with its origin area and multiple scores with their survival rates and hospital stay.


Description:

Objective:

To evaluate origins of Fournier's gangrene as a prognostic value in the morbidity and mortality.

Patients and methods:

This is a retrospective study where patients from a single hospital from 2007 to 2016 were included. They were categorized in 4 groups matching the origin of infection. In every group categorizing with the origin of infection and determined severity factors, days of hospital stay, Fournier's gangrene severity index and mortality. A statistic analysis will be done using lineal multivariable analysis.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date February 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria

- Male Patient

- Fournier's Gangrene

- All patients treated with two antibiotics

- All patients undergone with aggressive debridement

Exclusion Criteria

- Female

- Not having Fournier's Gangrene

Study Design


Intervention

Procedure:
Aggressive debridement
Aggressive debridement of the tissues undergoing fascitis

Locations

Country Name City State
Mexico Hospital Universitario "Dr Jose Eleuterio Gonzalez" Monterrey

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fournier's Gangrene Severity Index A score to predict mortality in this kind of patients 0-24 hours
Primary Hospital stay ( in days) The patients hospital stay 0 to 2 months
Primary Couture Positive or negative couture and the bacterias growing in the abscess 24 hours
Secondary Diabetes mellitus if the patient had diabetes mellitus type 2 or not 0 - 100 years
Secondary Hypertension if the patient had arterial hypertension or not 0 - 100 years
Secondary Alcohol drinking if the patient drinks alcohol or not 0 - 100 years
Secondary Tobacco smoking if the patient smokes or not 0 - 100 years
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