Fournier's Gangrene in Patient With Uncontrolled Type 2 Diabetes

Sponsor

University of Catania (Other)

Overall Status

Completed

CT.gov ID

NCT04694053

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 66-year-old man, with a history of uncontrolled type 2 diabetes, obesity with BMI 38, chronic kidney failure and chronic heart failure, was admitted to the Emergency Department with a large area of necrosis involving the perineal and perianal regions.

Condition or Disease	Intervention/Treatment	Phase
Fournier Gangrene	Procedure: surgical debridement

Detailed Description

Fournier's gangrene is a potentially fatal emergency condition, supported by an infection of perineal and perianal region, characterized by necrotizing fasciitis with a rapid spread to fascial planes. FG, usually due to compromised host, may be sustained by many microbial pathogens.

Study Design

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Fournier's Gangrene as a Rare Complication in Patient With Uncontrolled Type 2 Diabetes Treated With Surgical Debridement: a Case Report and Literature Review

Actual Study Start Date :

Nov 4, 2020

Actual Primary Completion Date :

Nov 10, 2020

Actual Study Completion Date :

Dec 1, 2020

Outcome Measures

Primary Outcome Measures

Number of Participants [From 3 November 2020 at 23 November 2020]
Number of patients enrolled by the emergency room.
Fournier's gangrene evolution after treatment [20 days]
Evolution of gangrene after surgical debridement of perineal and perianal regions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of Fournier's Gangrene Insulin dependent diabetes (type 2)

Exclusion Criteria:

n/a

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Catania	Catania		Italy	95123

Sponsors and Collaborators

University of Catania

Investigators

Principal Investigator: Daniele o Provenzano, md, https://www.unict.it/

Study Documents (Full-Text)

Study Protocol - Dec 22, 2020

More Information

Publications

None provided.

Responsible Party:

Daniele Provenzano, Principal Investigator, University of Catania

ClinicalTrials.gov Identifier:

NCT04694053

Other Study ID Numbers:

Clinica Ch 1

First Posted:

Jan 5, 2021

Last Update Posted:

Jan 5, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Daniele Provenzano, Principal Investigator, University of Catania

Fournier's gangrene

Type 2 diabetes

surgical debridement

Additional relevant MeSH terms:

Fournier Gangrene

Diabetes Mellitus, Type 2

Gangrene

Study Results

No Results Posted as of Jan 5, 2021