Fournier's Gangrene in Patient With Uncontrolled Type 2 Diabetes

Fournier Gangrene Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694053
• Other study ID #: Clinica Ch 1
• Status: Completed
• Start date: November 4, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 1, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

n/a

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fournier Gangrene
• Gangrene

Intervention

Procedure:
• surgical debridement
The surgical team performed an extended surgical debridement to healthy tissue of external genital, as well as perineal, perianal, and infrapubic regions.

Locations

Country	Name	City	State
Italy	University of Catania	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants	Number of patients enrolled by the emergency room.	From 3 November 2020 at 23 November 2020
Primary	Fournier's gangrene evolution after treatment	Evolution of gangrene after surgical debridement of perineal and perianal regions.	20 days