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Completed

NCT Number: NCT05529628

The Immunological Differences Between Fournier Gangrene and Perianal Abscess

Although it is rarely observed, necrotizing fasciitis progresses with high mortality and serious complications. Fournier's gangrene is a specific form of necrotizing fasciitis. In laboratory tests, leukocytosis or leukopenia, anemia, lymphopenia can be observed. Perianal abscess is a surgical emergency that is observed much more frequently than necrotizing fasciitis. Although Fournier's gangrene has many different etiologies, it rarely occurs due to the progression of perianal abscess, and although it is difficult to distinguish between these two diseases at diagnosis, the two diseases manifest themselves as different entities. In this study, blood cytokine levels will be evaluated in patients with Fournier's gangrene and perianal abscess, and the role of blood cytokine levels in the differential diagnosis of these two diseases will be investigated.

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Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey (Türkiye)

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About this study

Although it is rarely observed, necrotizing fasciitis progresses with high mortality and serious complications. Fournier's gangrene is a specific form of necrotizing fasciitis and is located in the external genital organs and perianal region, causing thrombosis in the arteries feeding this region, gangrene in the skin and subcutaneous tissues, sepsis, and multiorgan failure.

The prognosis of Fournier's gangrene is closely related to the time of initiation of treatment. In cases where treatment is delayed, high mortality can be observed due to septic shock and related complications.

In laboratory tests, leukocytosis or leukopenia, anemia, and lymphopenia can be observed. In a study evaluating conditions that increase mortality with soft tissue necrosis, it was reported that high body mass index, abnormal leukocytes, CRP and platelet values were proportional to the severity of the disease.

Perianal abscess is a surgical emergency that is observed much more frequently than necrotizing fasciitis. Patients usually present with an erythematous swelling near the anus and hesitate to be examined. About 90% of idiopathic perianal abscesses occur due to infection of the cryptoglandular glands.

Although Fournier's gangrene has many different etiologies, it rarely occurs due to the progression of perianal abscess, and although it is difficult to distinguish between these two diseases in the diagnosis, the two diseases manifest themselves as different entities. In a study, higher IL17 levels were found in perianal abscess patients compared to the control group. Apart from this, we did not find any study on blood cytokine levels in patients with perianal abscess or Fournier's gangrene in our literature review.

In this study, blood cytokine levels will be evaluated in patients with Fournier's gangrene and perianal abscess, and the role of blood cytokine levels in the differential diagnosis of these two diseases will be investigated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients applying to the emergency department with Fournier's gangrene and perianal abscess.

Exclusion criteria

  • Patients with primary immunodeficiency
  • Crohn's patients
  • HIV patients,
  • Cancer patients,
  • Pregnancy,
  • Patients younger than 18 years and older than 88 years
  • Patients who did not agree to participate in the study

Treatment and study plan

Cytokine levels

Diagnostic Test

Preoperative cytokine levels of the patients

Primary outcomes

  1. Cytokines

    Time frame: 1 day

    Values in pg/ml of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

The Cytokines and Immune Checkpoint Differences Between Fournier Gangrene and Perianal Abscess

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Sep 11, 2023

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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