Predictive Modeling of Necrotizing Skin Infections in Snakebite Patients

October 1, 2024 updated by: Zhibin Xu, Guangzhou Institute of Respiratory Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhanjiang, Guangdong, China, 524002
        • Affiliated Hospital Of Guangdong Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Antivenom Serum
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.
Procedure: Wound Debridement
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.
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.
Drug: Antivenom Serum
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.
Procedure: Wound Debridement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days from admission or until discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: From hospital admission until discharge, typically ranging between 1 and 30 days.
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.
From hospital admission until discharge, typically ranging between 1 and 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Central People's Hospital of Zhanjiang
Affiliated Hospital of Guangdong Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20240521-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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