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

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ClinicalTrials.gov Identifier: NCT03443544
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Adrián Gutiérrez González, 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.


Condition or disease Intervention/treatment
Fournier Gangrene Fournier's Gangrene of Penis Fournier's Gangrene of Scrotum 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.


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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gangrene

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients with Fournier's Gangrene
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients from a single hospital (Hospital Universitario "Dr Jose E. Gonzalez") from 2007 to 2016 were included.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443544


Locations
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Mexico
Hospital Universitario "Dr Jose Eleuterio Gonzalez"
Monterrey, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez

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Responsible Party: Adrián Gutiérrez González, Chief of department, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03443544     History of Changes
Other Study ID Numbers: UR16-00003
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adrián Gutiérrez González, Hospital Universitario Dr. Jose E. Gonzalez:
fournier's
gangrene

Additional relevant MeSH terms:
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Gangrene
Fournier Gangrene
Necrosis
Pathologic Processes
Bacterial Infections
Genital Diseases, Male