ClinicalTrials.gg
CompletedNCT06622343Updated Oct 2, 2024

Predictive Modeling of Necrotizing Skin Infections in Snakebite Patients

An observational study in Necrotizing Skin Infections and Snakebite Envenomation, sponsored by Guangzhou Institute of Respiratory Disease. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Guangzhou Institute of Respiratory Disease · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
99
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Necrotizing Skin Infections
  • Snakebite Envenomation

Browse trials for

Keywords

  • Snakebite
  • Necrotizing Infection
  • Risk Factors
  • Predictive Modeling
  • Venomous Snakes
  • D-dimer
  • Snakebite Severity Score
  • Blood Glucose Levels
03

In context

Snake Bites

38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.

This study's enrollment of 99 is close to the median of 99 across 19 observational studies indexed under Snake Bites.

Browse Snake Bites studies →

Lead sponsor

Guangzhou Institute of Respiratory Disease is the lead sponsor of 99 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by the patients or their legal guardians.

Exclusion criteria

Exclusion Criteria:

  • Age less than 14 years.
  • Long-term use of or .
  • Presence of concurrent immunodeficiency diseases (e.g., positive).
  • Severe malnutrition.
  • Incomplete medical records.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
99 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • DrugAntivenom 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.

  • ProcedureWound 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.

06

What researchers measure

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.

    Time frame: 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.

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

07

Study locations

1 site
  • Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong 524002, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Apr 2024, 51 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2024
First posted
Oct 2, 2024
StartActual
Jan 1, 2020
Primary completionActual
Apr 1, 2024
CompletionActual
Apr 30, 2024
Last update
Oct 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06622343
Lead sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Central People's Hospital of Zhanjiang, Affiliated Hospital of Guangdong Medical University
Responsible party
Zhibin Xu (Professor, Guangzhou Institute of Respiratory Disease) — Principal investigator
First posted
Oct 2, 2024
Start date
Jan 1, 2020
Primary completion
Apr 1, 2024
Completion
Apr 30, 2024
Last update
Oct 2, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion