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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04694053
Other study ID # Clinica Ch 1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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