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Completed

NCT Number: NCT04470791

Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Introduction: Local cryotherapy induces vasoconstriction, which leads to a reduction in the inflammatory process. However, the efficacy of local cryotherapy as a coadjuvant in snakebite treatment with F(ab')2 antivenom is unknown.

Objective: Determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom.

Material and methods: Subjects with snakebite envenomation accident grade II, according to the Christopher-Rodning classification, were enrolled from the Clinical Toxicology Service of the Hospital Juárez de México. One group of patients received F(ab')2 antivenom therapy (antivipmyn®) plus local cryotherapy, and another group received only F(ab')2 antivenom therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both genders and any age with a snake bite of poison grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.

Exclusion criteria

  • Patients of both genders and any age with a snake bite of poison grade I, III or IV who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.

Treatment and study plan

F(ab)2 antivenom therapy (antivipmyn®).

Biological

Antivipmyn is an equine origin antivenom produced by Institute Bioclon in Mexico (Silanes Laboratories, México). The snake venoms used to create the F(ab')2 fragments are from Crotalus durissus and Bothrops asper. The number of doses of each patient depended on the classification and evolution, as indicated by the manufacturer for grade II envenoming: from 6 to 10 bottles of F(ab)2 antivenom therapy, intravenously, as an initial dose. One dose (bottle) consisted of 10 mL of polyvalent concentrated and modified horse antibodies treated by enzymatic digestion to neutralize the Bothrops asper venom to not less than 780 lethal dose 50 (LD50), and the Crotalus basiliscus venom to not less than 790 LD50.

Local cryotherapy.

Procedure

Interval cryotherapy consisted of applying a plastic bag (the size of the bag depending on the size of the lesion, approximately 28 x 46 cm) two-thirds filled with crushed ice (frapped) wrapped in a towel applied for 20 minutes every 4 hours at the site of the snakebite throughout the hospital stay. New ice bags were used after 4 hours.

Primary outcomes

  1. Distal circumference of the affected limb on hospital admission.

    Time frame: Baseline.

    The circumference values of the injured limb were measured in the distal circumference (site farthest from the bite with the estimated maximum degree of edema, or at the end of the limb) on the affected extremity.

  2. Proximal circumference of the affected limb on hospital admission.

    Time frame: Baseline.

    The circumference values of the injured limb were measured in the proximal circumference (5-10 cm from the site of the bite) on the affected extremity.

  3. Middle circumference of the affected limb on hospital admission.

    Time frame: Baseline.

    The circumference values of the injured limb were measured in the middle circumference (intermediate measurement between the proximal and distal diameter) on the affected extremity.

  4. Distal circumference of the affected limb on hospital admission.

    Time frame: up to 24 weeks

    The circumference values of the injured limb were measured in the distal circumference (site farthest from the bite with the estimated maximum degree of edema, or at the end of the limb) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.

  5. Proximal circumference of the affected limb on hospital admission.

    Time frame: up to 24 weeks.

    The circumference values of the injured limb were measured in the proximal circumference (5-10 cm from the site of the bite) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.

  6. Middle circumference of the affected limb on hospital admission.

    Time frame: up to 24 weeks.

    The circumference values of the injured limb were measured in the middle circumference (intermediate measurement between the proximal and distal diameter) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.

Secondary outcomes

  1. Hospital stay.

    Time frame: up to 24 weeks.

    The length of an inpatient episode of care, calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital. Patients admitted and discharged on the same day have a length of stay of less than one day.

Sponsors and collaborators

Lead sponsor

Hospital Juarez de Mexico

Other Gov

Registry information

Official study title

Cryotherapy as a Coadjuvant in the Management of Crotaline Snakebite With F(ab')2 Antivenom: A Randomized Pilot Study.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2020
Registry last updated
Feb 28, 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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