NCT05529628

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

September 3, 2022

Last Update Submit

September 7, 2023

Conditions

Fournier GangrenePerianal Abscess

Keywords

CytokineinflammationFournier GangrenePerianal Abscess

Outcome Measures

Primary Outcomes (1)

  • Cytokines

    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

    1 day

Study Arms (3)

Control

Healthy volunteers with no known chronic or cancer disease

Diagnostic Test: Cytokine levels

Fournier's gangrene

Fournier's gangrene patients

Diagnostic Test: Cytokine levels

Perianal abscess

Perianal abscess patients

Diagnostic Test: Cytokine levels

Interventions

Cytokine levelsDIAGNOSTIC_TEST

Preoperative cytokine levels of the patients

ControlFournier's gangrenePerianal abscess

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this study, patients who applied to the emergency department with rectal pain and were diagnosed with perianal abscess or Fournier's gangrene and volunteers in the same age range without any disease will be included.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Seyrantepe Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Diab J, Bannan A, Pollitt T. Necrotising fasciitis. BMJ. 2020 Apr 27;369:m1428. doi: 10.1136/bmj.m1428. No abstract available.

    PMID: 32341079BACKGROUND

  • Wang JP, Cai C, Du JL, Shi HQ, Liu QW, Dai ZH, Zhong ZF. Role of interleukin-17 in the pathogenesis of perianal abscess and anal fistula: a clinical study on 50 patients with perianal abscess. ANZ J Surg. 2019 Mar;89(3):244-247. doi: 10.1111/ans.14874. Epub 2018 Oct 25.

    PMID: 30362208BACKGROUND

  • Park SJ, Kim DH, Choi CI, Yun SP, Kim JH, Seo HI, Jo HJ, Jun TY. Necrotizing soft tissue infection: analysis of the factors related to mortality in 30 cases of a single institution for 5 years. Ann Surg Treat Res. 2016 Jul;91(1):45-50. doi: 10.4174/astr.2016.91.1.45. Epub 2016 Jun 30.

    PMID: 27433464BACKGROUND

MeSH Terms

Conditions

Fournier GangreneInflammation

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. MD. PhD

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 7, 2022

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

TU(2)