Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients

Fournier Gangrene Clinical Trial

Official title:

Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443544
• Other study ID #: UR16-00003
• 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
• 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

Related Conditions & MeSH terms

• Fournier Gangrene
• Fournier's Gangrene of Penis
• Fournier's Gangrene of Scrotum
• Gangrene

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