Fournier's GangrenePhase 3NCT06809738
Anatomical Scale for the Prognosis of Fournier Syndrome.
A Phase 3 study testing reconstructive technique in people with Fournier's Gangrene, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Type of study: Case series. Universe of study: Records of patients with Fournier syndrome treated using the 3-stage reconstructive technique assigned and treated at the Mexican Social Security Institute: Regional General Hospital No. 1 of Mérida, Yucatán, during the years 2021-2024. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Fournier's Gangrene
- What is being tested?
- reconstructive technique
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Phase 3
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with perineal necrotizing fasciitis (Fournier syndrome), at the General Hospital Zone No. 1, aged between 40-85 years, who have undergone surgery
Who cannot join
- Those who could not be followed up due to incomplete records. Those who did not complete the three procedures due to mortality associated with primary pathologies independent of necrotizing fasciitis.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Mexican Social Security Institute: Regional General Hospital No. 1
Mérida, Yucatán, 97000
About this study
Official title: Proposal for an Anatomical Scale for the Prognosis of Fournier Syndrome.
Type of study: Case series. Universe of study: Records of patients with Fournier syndrome treated using the 3-stage reconstructive technique assigned and treated at the Mexican Social Security Institute: Regional General Hospital No. 1 of Mérida, Yucatán, during the years 2021-2024.
Population under study: Patients diagnosed with Fournier syndrome.
Read the detailed description
The first surgical stage consists of damage limitation and extension analysis. In the second surgical stage, it was necessary to wash and prepare the area to be remodeled with the joint creation of the testicular resting space delimited by the fascia of the adductor muscles of the proximal lower limb. Finally, in the third surgical stage, the wound is remodeled and addressed. The surgery was performed in patients with extensive involvement that could not be resolved with minor surgery.
The 3-stage reconstructive technique can be summarized as follows:
- Analysis and limitation of the tissue injury. Bilateral testicular and spermatic cord dissection.
- Formation of cutaneous flaps and bilateral inguinal neocavity.
- Perineal-scrotal reconstruction with fascial facing and cutaneous flaps
- Conditions
- Fournier's Gangrene
- Being tested
- reconstructive technique
- Keywords
- Surgery, Infection, tissue, scrotal
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reconstructive techniqueProcedure or surgery
- Analysis and limitation of the tissue injury. Bilateral testicular and spermatic cord dissection.
- Formation of cutaneous flaps and bilateral inguinal neocavity.
- Perineal-scrotal reconstruction with fascial facing and cutaneous flaps
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To determine the presence of mortality in patients with Fournier syndrome who underwent surgery using the 3-stage reconstructive technique.
Measured: From the diagnosis to the surgery and 30 day post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jan 2021
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fournier's 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3-stage reconstructive technique
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huber Díaz Fuentes, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809738
- Sponsor's protocol ID
- 2311
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: due to the reproducibility of the study
Publications
Lewis GD, Majeed M, Olang CA, Patel A, Gorantla VR, Davis N, Gluschitz S. Fournier's Gangrene Diagnosis and Treatment: A Systematic Review. Cureus. 2021 Oct 21;13(10):e18948. doi: 10.7759/cureus.18948. eCollection 2021 Oct.
PubMed 34815897Singh A, Ahmed K, Aydin A, Khan MS, Dasgupta P. Fournier's gangrene. A clinical review. Arch Ital Urol Androl. 2016 Oct 5;88(3):157-164. doi: 10.4081/aiua.2016.3.157.
PubMed 27711086
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for an Anatomical Scale for the Prognosis of Fournier Syndrome.
- ClinicalTrials.gov ID
- NCT06809738
- Acronym / sponsor ID
- 2311
- Conditions
- Fournier's Gangrene
- Keywords
- Surgery, Infection, tissue, scrotal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Feb 2025 (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.
Type of study: Case series. Universe of study: Records of patients with Fournier syndrome treated using the 3-stage reconstructive technique assigned and treated at the Mexican Social Security Institute: Regional General Hospital No. 1 of Mérida, Yucatán, during the years 2021-2024.
Population under study: Patients diagnosed with Fournier syndrome.
Detailed description
The first surgical stage consists of damage limitation and extension analysis. In the second surgical stage, it was necessary to wash and prepare the area to be remodeled with the joint creation of the testicular resting space delimited by the fascia of the adductor muscles of the proximal lower limb. Finally, in the third surgical stage, the wound is remodeled and addressed. The surgery was performed in patients with extensive involvement that could not be resolved with minor surgery.
The 3-stage reconstructive technique can be summarized as follows:
- Analysis and limitation of the tissue injury. Bilateral testicular and spermatic cord dissection.
- Formation of cutaneous flaps and bilateral inguinal neocavity.
- Perineal-scrotal reconstruction with fascial facing and cutaneous flaps
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- 3-stage reconstructive technique
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with perineal necrotizing fasciitis (Fournier syndrome), at the General Hospital Zone No. 1, aged between 40-85 years, who have undergone surgery
Key exclusion criteria (1 listed)
- Those who could not be followed up due to incomplete records. Those who did not complete the three procedures due to mortality associated with primary pathologies independent of necrotizing fasciitis.
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 |
|---|---|---|
| reconstructive technique1. Analysis and limitation of the tissue injury. Bilateral testicular and spermatic cord dissection. 2. Formation of cutaneous flaps and bilateral inguinal neocavity. 3. Perineal-scrotal reconstruction with fascial facing and cutaneous flaps | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: From the diagnosis to the surgery and 30 day post op
To determine the presence of mortality in patients with Fournier syndrome who underwent surgery using the 3-stage reconstructive technique.
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 5 Feb 2025.
- Results publication: PubMed 34815897Lewis GD, Majeed M, Olang CA, Patel A, Gorantla VR, Davis N, Gluschitz S. Fournier's Gangrene Diagnosis and Treatment: A Systematic Review. Cureus. 2021 Oct 21;13(10):e18948. doi: 10.7759/cureus.18948. eCollection 2021 Oct.
- Results publication: PubMed 27711086Singh A, Ahmed K, Aydin A, Khan MS, Dasgupta P. Fournier's gangrene. A clinical review. Arch Ital Urol Androl. 2016 Oct 5;88(3):157-164. doi: 10.4081/aiua.2016.3.157.
- Individual participant dataSharing planned: Undecided. due to the reproducibility of the study
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?
A Phase 3 study testing reconstructive technique in people with Fournier's Gangrene, run by Instituto Mexicano del Seguro Social 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 1 inclusion and 1 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 5 Feb 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mortality (time frame: From the diagnosis to the surgery and 30 day post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06809738, which also lists 2 linked publications.
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 5 Feb 2025.