Fournier GangreneNCT03443544
Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients
An observational study of Fournier Gangrene and Fournier's Gangrene of Penis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Fournier Gangrene, Fournier's Gangrene of Penis, Fournier's Gangrene of Scrotum
- What is being tested?
- Aggressive debridement
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2017to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from a single hospital (Hospital Universitario "Dr Jose E. Gonzalez") from 2007 to 2016 were included.
Who may be able to join
- Male Patient
- Fournier's Gangrene
- All patients treated with two antibiotics
- All patients undergone with aggressive debridement
Who cannot join
- Female
- Not having Fournier's Gangrene
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "Dr Jose Eleuterio Gonzalez"
Monterrey, 64460
About this study
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.
Read the detailed description
Objective:
To evaluate origins of Fournier's gangrene as a prognostic value in the morbidity and mortality.
Patients and methods:
This is a retrospective study where patients from a single hospital from 2007 to 2016 were included. They were categorized in 4 groups matching the origin of infection. In every group categorizing with the origin of infection and determined severity factors, days of hospital stay, Fournier's gangrene severity index and mortality. A statistic analysis will be done using lineal multivariable analysis.
- Being tested
- Aggressive debridement
- Keywords
- fournier's, gangrene
- Medical subject headings
- Fournier Gangrene, Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggressive debridementProcedure or surgery
Aggressive debridement of the tissues undergoing fascitis
| Study group | Role | What they receive |
|---|---|---|
| Intestinal origin | Either perianal abcess or rectal carcinoma Receives: Procedure: Aggressive debridement | |
| Testicular Origin | Complicated epididymitis with fascitis, Receives: Procedure: Aggressive debridement | |
| Urinary Origin | From urinary tract infection or fistulae from urethral trauma Receives: Procedure: Aggressive debridement | |
| Cutaneous Origin | mostly folliculitis, and skin infections Receives: Procedure: Aggressive debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fournier's Gangrene Severity Index
A score to predict mortality in this kind of patients
Measured: 0-24 hours
Hospital stay ( in days)
The patients hospital stay
Measured: 0 to 2 months
Couture
Positive or negative couture and the bacterias growing in the abscess
Measured: 24 hours
Secondary outcomes (4)
Diabetes mellitus
if the patient had diabetes mellitus type 2 or not
Measured: 0 - 100 years
Hypertension
if the patient had arterial hypertension or not
Measured: 0 - 100 years
Alcohol drinking
if the patient drinks alcohol or not
Measured: 0 - 100 years
Tobacco smoking
if the patient smokes or not
Measured: 0 - 100 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Nov 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fournier GangreneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Gutiérrez González, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443544
- Sponsor's protocol ID
- UR16-00003
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients
- ClinicalTrials.gov ID
- NCT03443544
- Acronym / sponsor ID
- UR16-00003
- Keywords
- fournier's, gangrene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
To evaluate origins of Fournier's gangrene as a prognostic value in the morbidity and mortality.
Patients and methods:
This is a retrospective study where patients from a single hospital from 2007 to 2016 were included. They were categorized in 4 groups matching the origin of infection. In every group categorizing with the origin of infection and determined severity factors, days of hospital stay, Fournier's gangrene severity index and mortality. A statistic analysis will be done using lineal multivariable analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intestinal origin | – | Procedure: Aggressive debridementEither perianal abcess or rectal carcinoma |
| Testicular Origin | – | Procedure: Aggressive debridementComplicated epididymitis with fascitis, |
| Urinary Origin | – | Procedure: Aggressive debridementFrom urinary tract infection or fistulae from urethral trauma |
| Cutaneous Origin | – | Procedure: Aggressive debridementmostly folliculitis, and skin infections |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from a single hospital (Hospital Universitario "Dr Jose E. Gonzalez") from 2007 to 2016 were included.
Key inclusion criteria (4 listed)
- Male Patient
- Fournier's Gangrene
- All patients treated with two antibiotics
- All patients undergone with aggressive debridement
Key exclusion criteria (2 listed)
- Female
- Not having Fournier's Gangrene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggressive debridementAggressive debridement of the tissues undergoing fascitis | Procedure or surgery | Cutaneous Origin, Intestinal origin, Testicular Origin, Urinary Origin |
Primary outcome
Fournier's Gangrene Severity Index
Time frame: 0-24 hours
A score to predict mortality in this kind of patients
Hospital stay ( in days)
Time frame: 0 to 2 months
The patients hospital stay
Couture
Time frame: 24 hours
Positive or negative couture and the bacterias growing in the abscess
4 secondary outcomes
Diabetes mellitus
Time frame: 0 - 100 years
Hypertension
Time frame: 0 - 100 years
Alcohol drinking
Time frame: 0 - 100 years
Tobacco smoking
Time frame: 0 - 100 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Fournier Gangrene
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
RecruitingObservational study
FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).
Necrotizing Fascitis, Fournier Gangrene
Enrolling by invitationObservational study
Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infection, Fournier Gangrene
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fournier Gangrene and Fournier's Gangrene of Penis, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fournier's Gangrene Severity Index (time frame: 0-24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.