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Completed

NCT Number: NCT06809738

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.

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Key information

Age range

40 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Mexican Social Security Institute: Regional General Hospital No. 1

Mérida, Yucatán, 97000, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reconstructive technique

Procedure
  • 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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Proposal for an Anatomical Scale for the Prognosis of Fournier Syndrome.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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