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Completed

NCT Number: NCT03443544

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.

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Key information

Conditions

Fournier Gangrene Bacterial Infections Bacterial Infections and Mycoses Fournier's Gangrene of Penis Fournier's Gangrene of Scrotum Gangrene Genital Diseases Genital Diseases, Male Infections Male Urogenital Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Primary location

Hospital Universitario "Dr Jose Eleuterio Gonzalez"

Monterrey, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aggressive debridement

Procedure

Aggressive debridement of the tissues undergoing fascitis

Primary outcomes

  1. Fournier's Gangrene Severity Index

    Time frame: 0-24 hours

    A score to predict mortality in this kind of patients

  2. Hospital stay ( in days)

    Time frame: 0 to 2 months

    The patients hospital stay

  3. Couture

    Time frame: 24 hours

    Positive or negative couture and the bacterias growing in the abscess

Secondary outcomes

  1. Diabetes mellitus

    Time frame: 0 - 100 years

    if the patient had diabetes mellitus type 2 or not

  2. Hypertension

    Time frame: 0 - 100 years

    if the patient had arterial hypertension or not

  3. Alcohol drinking

    Time frame: 0 - 100 years

    if the patient drinks alcohol or not

  4. Tobacco smoking

    Time frame: 0 - 100 years

    if the patient smokes or not

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2018
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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