NCT03443544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

February 12, 2018

Last Update Submit

February 22, 2018

Conditions

Fournier GangreneFournier's Gangrene of PenisFournier's Gangrene of Scrotum

Keywords

fournier'sgangrene

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Diabetes mellitus

    0 - 100 years

  • Hypertension

    0 - 100 years

  • Alcohol drinking

    0 - 100 years

  • Tobacco smoking

    0 - 100 years

Study Arms (4)

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

Aggressive debridementPROCEDURE

Aggressive debridement of the tissues undergoing fascitis

Cutaneous OriginIntestinal originTesticular OriginUrinary Origin

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patients with Fournier's Gangrene
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Female
  • Not having Fournier's Gangrene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "Dr Jose Eleuterio Gonzalez"

Monterrey, 64460, Mexico

Location

MeSH Terms

Conditions

Fournier GangreneGangrene

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of department

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 23, 2018

Study Start

November 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)