NCT04983056

Brief Summary

Case series with retrospective data collection of patients treated for Fournier's gangrene between January 2010 and March 2017. The main etiologies, risk factors, postoperative complications outcomes and long term follow up results were analyzed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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

January 1, 2010

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

7.2 years

First QC Date

July 7, 2021

Last Update Submit

July 19, 2021

Conditions

Fournier Gangrene

Keywords

Fournier's Gangrene, stoma, necrosectomy

Outcome Measures

Primary Outcomes (1)

  • Number of patients who died for fournier gangrene

    The mortality rate of patients with Fournier Gangrene after six months

    Six months

Interventions

Necrotesectomy associated with cleanleness stomaPROCEDURE

Excision of all necrotised tissues after stool diversion and wound dressing using

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

. Patients with Fournier Gangrene

You may qualify if:

  • Clinical diagnosis of Fournier Gangrene

You may not qualify if:

  • Other perineal diseases which are differential diagnosis of Fournier gangrene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

The pus from purulent and necrotized tissues

MeSH Terms

Conditions

Fournier Gangrene

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 30, 2021

Study Start

January 1, 2010

Primary Completion

March 31, 2017

Study Completion

July 2, 2021

Last Updated

July 30, 2021

Record last verified: 2021-07