Predictive Modeling of Necrotizing Skin Infections in Snakebite Patients

Completed

• Conditions: Necrotizing Skin Infections; Snakebite Envenomation
• Interventions: Drug: Antivenom Serum; Procedure: Wound Debridement

• Registration Number: NCT06622343
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief 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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-30
• Study First Submitted: 2024-09-29
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Necrotizing Skin Infections Group	Antivenom Serum	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.
Necrotizing Skin Infections Group	Wound Debridement	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.
Non-Infection Group	Antivenom Serum	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.
Non-Infection Group	Wound Debridement	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Necrotizing Skin Infections	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.

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	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.

Trial Locations

Locations (1)

Affiliated Hospital of Guangdong Medical University; 🇨🇳 Zhanjiang, Guangdong, China