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

Completed

• Conditions: Fournier's Gangrene of Penis; Fournier Gangrene; Fournier's Gangrene of Scrotum
• Interventions: Procedure: Aggressive debridement

• Registration Number: NCT03443544
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-11-01
• Status Verified: 2018-02
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urinary Origin	Aggressive debridement	From urinary tract infection or fistulae from urethral trauma
Cutaneous Origin	Aggressive debridement	mostly folliculitis, and skin infections
Intestinal origin	Aggressive debridement	Either perianal abcess or rectal carcinoma
Testicular Origin	Aggressive debridement	Complicated epididymitis with fascitis,

Primary Outcome Measures

Name	Time	Method
Fournier's Gangrene Severity Index	0-24 hours	A score to predict mortality in this kind of patients
Hospital stay ( in days)	0 to 2 months	The patients hospital stay
Couture	24 hours	Positive or negative couture and the bacterias growing in the abscess

Secondary Outcome Measures

Name	Time	Method
Tobacco smoking	0 - 100 years	if the patient smokes or not
Hypertension	0 - 100 years	if the patient had arterial hypertension or not
Alcohol drinking	0 - 100 years	if the patient drinks alcohol or not
Diabetes mellitus	0 - 100 years	if the patient had diabetes mellitus type 2 or not

Trial Locations

Locations (1)

Hospital Universitario "Dr Jose Eleuterio Gonzalez"; 🇲🇽 Monterrey, Mexico