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CompletedNCT03443544Updated Feb 23, 2018

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

An observational study in Fournier Gangrene, Fournier's Gangrene of Penis and Fournier's Gangrene of Scrotum, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to male participants. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
121
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Fournier Gangrene
  • Fournier's Gangrene of Penis
  • Fournier's Gangrene of Scrotum

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Keywords

  • fournier's
  • gangrene
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In context

Gangrene

23 studies on the registry are indexed under Gangrene; 3 are open to participants now.

Browse Gangrene studies →

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male Patient
  • Fournier's Gangrene
  • All patients treated with two antibiotics
  • All patients undergone with aggressive debridement

Exclusion criteria

Exclusion Criteria

  • Female
  • Not having Fournier's Gangrene
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
121 participants (actual)
Patient registry
No

Groups and cohorts

  • Intestinal origin

    Either perianal abcess or rectal carcinoma

    Procedure: Aggressive debridement

  • Testicular Origin

    Complicated epididymitis with fascitis,

    Procedure: Aggressive debridement

  • Urinary Origin

    From urinary tract infection or fistulae from urethral trauma

    Procedure: Aggressive debridement

  • Cutaneous Origin

    mostly folliculitis, and skin infections

    Procedure: Aggressive debridement

Interventions

  • ProcedureAggressive debridement

    Aggressive debridement of the tissues undergoing fascitis

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What researchers measure

Primary outcomes

  1. Fournier's Gangrene Severity Index

    A score to predict mortality in this kind of patients

    Time frame: 0-24 hours

  2. Hospital stay ( in days)

    The patients hospital stay

    Time frame: 0 to 2 months

  3. Couture

    Positive or negative couture and the bacterias growing in the abscess

    Time frame: 24 hours

Secondary outcomes

  1. Diabetes mellitus

    if the patient had diabetes mellitus type 2 or not

    Time frame: 0 - 100 years

  2. Hypertension

    if the patient had arterial hypertension or not

    Time frame: 0 - 100 years

  3. Alcohol drinking

    if the patient drinks alcohol or not

    Time frame: 0 - 100 years

  4. Tobacco smoking

    if the patient smokes or not

    Time frame: 0 - 100 years

07

Study locations

1 site
  • Hospital Universitario "Dr Jose Eleuterio Gonzalez"
    Monterrey, 64460, Mexico
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Feb 2018, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2018
First posted
Feb 23, 2018
StartActual
Nov 1, 2017
Primary completionActual
Feb 1, 2018
CompletionActual
Feb 1, 2018
Last update
Feb 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03443544
Lead sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Responsible party
Adrián Gutiérrez González (Chief of department, Hospital Universitario Dr. Jose E. Gonzalez) — Principal investigator
First posted
Feb 23, 2018
Start date
Nov 1, 2017
Primary completion
Feb 1, 2018
Completion
Feb 1, 2018
Last update
Feb 23, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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