Necrotizing Skin InfectionsNCT06622343
Predictive Modeling of Necrotizing Skin Infections in Snakebite Patients
An observational study of Necrotizing Skin Infections and Snakebite Envenomation, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This multicenter retrospective study aims to identify the risk factors associated with necrotizing skin infections following venomous snakebites and to develop a predictive model. Clinical data from 99 patients treated between January 2020 and April 2024 at three hospitals in Guangdong Province, China, were analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Skin Infections, Snakebite Envenomation
- What is being tested?
- Antivenom Serum and Wound Debridement
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Apr 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This study includes adult patients (aged 18 years and older) who were treated for venomous snakebites at three hospitals in Guangdong Province. The population consists of both male and female patients with confirmed envenomation and sufficient medical records for analysis.
Who may be able to join
- Diagnosis of venomous snake bites confirmed according to major international clinical guidelines and expert consensus.
- Availability of complete case data.
- Provision of written informed consent by the patients or their legal guardians.
Who cannot join
- Age less than 14 years.
- Long-term use of immunosuppressants or corticosteroids.
- Presence of concurrent immunodeficiency diseases (e.g., HIV positive).
- Severe malnutrition.
- Incomplete medical records.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524002
About this study
Official title: Risk Factor Analysis and Predictive Modeling for Necrotizing Skin Infections in Venomous Snakebite Patients: A Multicenter Retrospective Study
This multicenter retrospective study aims to identify the risk factors associated with necrotizing skin infections following venomous snakebites and to develop a predictive model. Clinical data from 99 patients treated between January 2020 and April 2024 at three hospitals in Guangdong Province, China, were analyzed.
Read the detailed description
Venomous snakebites are a significant public health issue, particularly in tropical and subtropical regions like southern China. Necrotizing skin infections are a severe but relatively rare complication of venomous snakebites, often resulting from delayed treatment and bacterial invasion. This study retrospectively analyzed clinical data from 99 patients with venomous snakebites treated at three hospitals in Guangdong Province between January 2020 and April 2024. The primary objective was to identify the major risk factors associated with the development of necrotizing skin infections and to build a predictive model to assist in clinical decision-making.
The study included male and female patients aged 14 years and older. Patients with incomplete medical records, long-term use of immunosuppressants, or underlying immunodeficiency diseases were excluded. Multivariate logistic regression identified the Snakebite Severity Score (SSS), blood glucose levels, and D-dimer levels as significant independent predictors of necrotizing infections.
- Being tested
- Antivenom Serum, Wound Debridement
- Keywords
- Snakebite, Necrotizing Infection, Risk Factors, Predictive Modeling, Venomous Snakes, D-dimer, Snakebite Severity Score, Blood Glucose Levels
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antivenom SerumDrug
Intravenous administration of 6000 IU of antivenom serum was given to patients envenomed by pit vipers. This treatment was based on Chinese guidelines for the management of snakebites. Additionally, patients received supportive treatments, including antibiotics to prevent infection, antihistamines for allergic reactions, and magnesium sulfate for localized swelling and pain relief.
Wound DebridementProcedure or surgery
Patients who did not develop necrotizing skin infections received wound management, including multiple punctures using a three-edged needle for toxin drainage, along with standard wound care and debridement as necessary to prevent infection and promote healing.
| Study group | Role | What they receive |
|---|---|---|
| Necrotizing Skin Infections Group | This cohort includes patients who developed necrotizing skin infections following venomous snakebites. These patients were treated at three hospitals in Guangdong Province between January 2020 and April 2024. The study aims to identify key risk factors, including Snakebite Severity Score (SSS), blood glucose levels, and D-dimer levels, that are associated with the development of necrotizing skin infections in these patients. Receives: Drug: Antivenom Serum; Procedure: Wound Debridement | |
| Non-Infection Group | This cohort includes patients who did not develop necrotizing skin infections after venomous snakebites. These patients were treated at the same three hospitals between January 2020 and April 2024. The cohort serves as a control group to compare against the infection group, helping to determine risk factors associated with necrotizing skin infections in snakebite patients. Receives: Drug: Antivenom Serum; Procedure: Wound Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Necrotizing Skin Infections
The primary outcome measure is the incidence of necrotizing skin infections among venomous snakebite patients within the study period. Necrotizing infections were identified based on clinical diagnostic criteria, including tissue necrosis, infection severity, and systemic symptoms.
Measured: 30 days from admission or until discharge.
Secondary outcomes (1)
Hospital Length of Stay
The secondary outcome measure is the duration of hospitalization for patients with venomous snakebites, comparing those who developed necrotizing skin infections with those who did not.
Measured: From hospital admission until discharge, typically ranging between 1 and 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jan 2020
- Primary completion1 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Skin InfectionsStudies 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
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Central People's Hospital of Zhanjiang, Affiliated Hospital of Guangdong Medical University
- Responsible party
- Principal investigator, Zhibin Xu, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622343
- Sponsor's protocol ID
- KY20240521-001
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor Analysis and Predictive Modeling for Necrotizing Skin Infections in Venomous Snakebite Patients: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06622343
- Acronym / sponsor ID
- KY20240521-001
- Keywords
- Snakebite, Necrotizing Infection, Risk Factors, Predictive Modeling, Venomous Snakes, D-dimer, Snakebite Severity Score, Blood Glucose Levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Central People's Hospital of Zhanjiang, Affiliated Hospital of Guangdong Medical University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 2 Oct 2024 (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.
This multicenter retrospective study aims to identify the risk factors associated with necrotizing skin infections following venomous snakebites and to develop a predictive model. Clinical data from 99 patients treated between January 2020 and April 2024 at three hospitals in Guangdong Province, China, were analyzed.
Detailed description
Venomous snakebites are a significant public health issue, particularly in tropical and subtropical regions like southern China. Necrotizing skin infections are a severe but relatively rare complication of venomous snakebites, often resulting from delayed treatment and bacterial invasion. This study retrospectively analyzed clinical data from 99 patients with venomous snakebites treated at three hospitals in Guangdong Province between January 2020 and April 2024. The primary objective was to identify the major risk factors associated with the development of necrotizing skin infections and to build a predictive model to assist in clinical decision-making.
The study included male and female patients aged 14 years and older. Patients with incomplete medical records, long-term use of immunosuppressants, or underlying immunodeficiency diseases were excluded. Multivariate logistic regression identified the Snakebite Severity Score (SSS), blood glucose levels, and D-dimer levels as significant independent predictors of necrotizing infections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Necrotizing Skin Infections Group | – | Drug: Antivenom Serum, Procedure: Wound DebridementThis cohort includes patients who developed necrotizing skin infections following venomous snakebites. These patients were treated at three hospitals in Guangdong Province between January 2020 and April 2024. The study aims to identify key risk factors, including Snakebite Severity Score (SSS), blood glucose levels, and D-dimer levels, that are associated with the development of necrotizing skin infections in these patients. |
| Non-Infection Group | – | Drug: Antivenom Serum, Procedure: Wound DebridementThis cohort includes patients who did not develop necrotizing skin infections after venomous snakebites. These patients were treated at the same three hospitals between January 2020 and April 2024. The cohort serves as a control group to compare against the infection group, helping to determine risk factors associated with necrotizing skin infections in snakebite patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients (aged 18 years and older) who were treated for venomous snakebites at three hospitals in Guangdong Province. The population consists of both male and female patients with confirmed envenomation and sufficient medical records for analysis.
Key inclusion criteria (3 listed)
- Diagnosis of venomous snake bites confirmed according to major international clinical guidelines and expert consensus.
- Availability of complete case data.
- Provision of written informed consent by the patients or their legal guardians.
Key exclusion criteria (5 listed)
- Age less than 14 years.
- Long-term use of immunosuppressants or corticosteroids.
- Presence of concurrent immunodeficiency diseases (e.g., HIV positive).
- Severe malnutrition.
- Incomplete medical records.
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 |
|---|---|---|
| Antivenom SerumIntravenous administration of 6000 IU of antivenom serum was given to patients envenomed by pit vipers. This treatment was based on Chinese guidelines for the management of snakebites. Additionally, patients received supportive treatments, including antibiotics to prevent infection, antihistamines for allergic reactions, and magnesium sulfate for localized swelling and pain relief. | Drug | Necrotizing Skin Infections Group, Non-Infection Group |
| Wound DebridementPatients who did not develop necrotizing skin infections received wound management, including multiple punctures using a three-edged needle for toxin drainage, along with standard wound care and debridement as necessary to prevent infection and promote healing. | Procedure or surgery | Necrotizing Skin Infections Group, Non-Infection Group |
Primary outcome
Incidence of Necrotizing Skin Infections
Time frame: 30 days from admission or until discharge.
The primary outcome measure is the incidence of necrotizing skin infections among venomous snakebite patients within the study period. Necrotizing infections were identified based on clinical diagnostic criteria, including tissue necrosis, infection severity, and systemic symptoms.
1 secondary outcome
Hospital Length of Stay
Time frame: From hospital admission until discharge, typically ranging between 1 and 30 days.
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 2 Oct 2024.
Related trials for Necrotizing Skin Infections
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
RecruitingObservational study
Myriad™ Augmented Soft Tissue Reconstruction Registry
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
Not yet recruitingObservational study
Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions
Necrotizing Fascitis, Cellulitis
Not yet recruitingObservational study
Patients With Necrotizing Skin and Soft Tissue Infections Managed Within the SURFAST Care Pathway.
Necrotizing Soft-tissue Infections
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Skin Infections and Snakebite Envenomation, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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 3 inclusion and 5 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Incidence of Necrotizing Skin Infections (time frame: 30 days from admission or until discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2024.