Fournier GangreneNCT05529628
The Immunological Differences Between Fournier Gangrene and Perianal Abscess
An observational study of Fournier Gangrene and Perianal Abscess, run by Istanbul Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Fournier Gangrene, Perianal Abscess
- What is being tested?
- Cytokine levels
- How many people
- 49 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients applying to the emergency department with Fournier's gangrene and perianal abscess.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Gaziosmanpasa Training and Research Hospital
Istanbul
Seyrantepe Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: The Cytokines and Immune Checkpoint 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.
Read the detailed description
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.
- Conditions
- Fournier Gangrene, Perianal Abscess
- Being tested
- Cytokine levels
- Keywords
- Cytokine, inflammation, Fournier Gangrene, Perianal Abscess
- Medical subject headings
- Fournier Gangrene, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine levelsDiagnostic test
Preoperative cytokine levels of the patients
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy volunteers with no known chronic or cancer disease Receives: Diagnostic Test: Cytokine levels | |
| Fournier's gangrene | Fournier's gangrene patients Receives: Diagnostic Test: Cytokine levels | |
| Perianal abscess | Perianal abscess patients Receives: Diagnostic Test: Cytokine levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fournier GangreneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529628
- Sponsor's protocol ID
- Fournier Gangrene
- Status last verified
- Sep 2023
- First submitted
- 3 Sep 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diab J, Bannan A, Pollitt T. Necrotising fasciitis. BMJ. 2020 Apr 27;369:m1428. doi: 10.1136/bmj.m1428. No abstract available.
PubMed 32341079Wang 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.
PubMed 30362208Park 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.
PubMed 27433464
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cytokines and Immune Checkpoint Differences Between Fournier Gangrene and Perianal Abscess
- ClinicalTrials.gov ID
- NCT05529628
- Acronym / sponsor ID
- Fournier Gangrene
- Conditions
- Fournier Gangrene, Perianal Abscess
- Keywords
- Cytokine, inflammation, Fournier Gangrene, Perianal Abscess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Cytokine levelsHealthy volunteers with no known chronic or cancer disease |
| Fournier's gangrene | – | Diagnostic Test: Cytokine levelsFournier's gangrene patients |
| Perianal abscess | – | Diagnostic Test: Cytokine levelsPerianal abscess patients |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients applying to the emergency department with Fournier's gangrene and perianal abscess.
Key exclusion criteria (7 listed)
- Patients with primary immunodeficiency
- Crohn's patients
- HIV patients,
- Cancer patients,
- Pregnancy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytokine levelsPreoperative cytokine levels of the patients | Diagnostic test | Control, Fournier's gangrene, Perianal abscess |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 32341079Diab J, Bannan A, Pollitt T. Necrotising fasciitis. BMJ. 2020 Apr 27;369:m1428. doi: 10.1136/bmj.m1428. No abstract available.
- Background: PubMed 30362208Wang 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.
- Background: PubMed 27433464Park 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.
- Individual participant dataSharing planned: Undecided
Related trials for Fournier Gangrene
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
RecruitingObservational study
FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).
Necrotizing Fascitis, Fournier Gangrene
Enrolling by invitationObservational study
Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infection, Fournier Gangrene
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fournier Gangrene and Perianal Abscess, run by Istanbul Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05529628, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.