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Completed

NCT Number: NCT06622343

Predictive Modeling of Necrotizing Skin Infections in Snakebite Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524002, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Collaborators

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

Registry information

Official study title

Risk Factor Analysis and Predictive Modeling for Necrotizing Skin Infections in Venomous Snakebite Patients: A Multicenter Retrospective Study

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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