Predictive Modeling of Necrotizing Skin Infections in Snakebite Patients

NCT06622343 | Completed

• 1 other identifier: KY20240521-001
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Skin Infections; Snakebite Envenomation

Keywords

Snakebite; Necrotizing Infection; Risk Factors; Predictive Modeling; Venomous Snakes; D-dimer; Snakebite Severity Score; Blood Glucose Levels

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days from admission or until discharge.

Secondary Outcomes (1)

• Hospital Length of Stay

  From hospital admission until discharge, typically ranging between 1 and 30 days.

Study Arms (2)

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; 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.

Drug: Antivenom Serum; Procedure: Wound Debridement

Interventions

Antivenom Serum DRUG

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.

Necrotizing Skin Infections Group; Non-Infection Group

Wound Debridement PROCEDURE

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.

Necrotizing Skin Infections Group; Non-Infection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Central People's Hospital of Zhanjiang: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator

Study Sites (1)

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524002, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study involved the collection of blood samples from patients upon hospital admission. The samples were used to measure key clinical markers such as blood glucose levels, D-dimer, C-reactive protein (CRP), white blood cell count (WBC), and other relevant biomarkers. These biospecimens were analyzed to identify potential predictors of necrotizing skin infections in patients with venomous snakebites. The samples were collected and processed according to standardized clinical protocols, but they were not retained for future genetic or DNA-based research.

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

CN (1)