Anatomical Scale for the Prognosis of Fournier Syndrome.

Phase 3

Completed

• Conditions: Fournier's Gangrene

• Registration Number: NCT06809738
• Lead Sponsor: Instituto Mexicano del Seguro Social

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

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mortality	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.

Trial Locations

Locations (1)

Mexican Social Security Institute: Regional General Hospital No. 1; 🇲🇽 Mérida, Estado de Yucatán, Mexico