Anatomical Scale for the Prognosis of Fournier Syndrome.

NCT ID: NCT06809738

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fournier's Gangrene

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

3-stage reconstructive technique
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

reconstructive technique

1. 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- patients diagnosed with perineal necrotizing fasciitis (Fournier syndrome), at the General Hospital Zone No. 1, aged between 40-85 years, who have undergone surgery

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Huber Díaz Fuentes

Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mexican Social Security Institute: Regional General Hospital No. 1

Mérida, Yucatán, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

References

Explore related publications, articles, or registry entries linked to this study.

Michael P, Peiris B, Ralph D, Johnson M, Lee WG. Genital Reconstruction following Fournier's Gangrene. Sex Med Rev. 2022 Oct 1;10(4):800-812. doi: 10.1016/j.sxmr.2022.05.002.

Reference Type BACKGROUND
PMID: 37051973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34815897 (View on PubMed)

Singh 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.

Reference Type BACKGROUND
PMID: 27711086 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2311

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hand Transplantation
NCT02476838 RECRUITING NA