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

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.

Study Overview

• Status: Completed
• Conditions: Fournier Gangrene; Fournier's Gangrene of Penis; Fournier's Gangrene of Scrotum
• Intervention / Treatment: Procedure: Aggressive debridement

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 Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Mexico
  • Monterrey, Mexico, 64460
    • Hospital Universitario "Dr Jose Eleuterio Gonzalez"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients from a single hospital (Hospital Universitario "Dr Jose E. Gonzalez") from 2007 to 2016 were included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intestinal origin; Either perianal abcess or rectal carcinoma	Procedure: Aggressive debridement; Aggressive debridement of the tissues undergoing fascitis
Testicular Origin; Complicated epididymitis with fascitis,	Procedure: Aggressive debridement; Aggressive debridement of the tissues undergoing fascitis
Urinary Origin; From urinary tract infection or fistulae from urethral trauma	Procedure: Aggressive debridement; Aggressive debridement of the tissues undergoing fascitis
Cutaneous Origin; mostly folliculitis, and skin infections	Procedure: Aggressive debridement; Aggressive debridement of the tissues undergoing fascitis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: fournier's; gangrene
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gangrene; Fournier Gangrene
• Other Study ID Numbers: UR16-00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No