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

NCT03443544 — Completed, 121 participants, Hospital Universitario Dr. Jose E. Gonzalez

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Registry	NCT03443544
Status	Completed
Study type	Observational
Enrollment	121 (Actual)
Sponsor	Hospital Universitario Dr. Jose E. Gonzalez (Other)
Conditions	Fournier Gangrene, Fournier's Gangrene of Penis, Fournier's Gangrene of Scrotum
Interventions	Aggressive debridement (Procedure)
Dates	start 2017-11-01, primary completion 2018-02-01, completion 2018-02-01, first posted 2018-02-23, last updated 2018-02-23
Locations	1 site in Mexico

-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.

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+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.

+Arms and interventions

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

Aggressive debridement (Procedure): Aggressive debridement of the tissues undergoing fascitis

+Outcome measures

Primary outcomes

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 outcomes

Diabetes mellitus [0 - 100 years]: if the patient had diabetes mellitus type 2 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
Tobacco smoking [0 - 100 years]: if the patient smokes or not

+Eligibility

Sex: Male

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

+Locations (1)

Facility	City	Country	Status
Hospital Universitario "Dr Jose Eleuterio Gonzalez"	Monterrey	Mexico