Clinical trial NCT06809738: Anatomical Scale for the Prognosis of Fournier Syndrome.
Official title: Proposal for an Anatomical Scale for the Prognosis of Fournier Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fournier&#39;s Gangrene
Keywords: Surgery
Infection
tissue
scrotal
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2025-02-05
Enrollment: 58
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 3-stage reconstructive technique
Primary purpose: TREATMENT

Brief 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.

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:

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

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: From the diagnosis to the surgery and 30 day post op
Secondary outcomes:
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Mexican Social Security Institute: Regional General Hospital No. 1
state: Estado de Yucatán
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.