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Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

Not Applicable
Completed
Conditions
Snake Bites
Interventions
Biological: F(ab)2 antivenom therapy (antivipmyn®).
Procedure: Local cryotherapy.
Registration Number
NCT04470791
Lead Sponsor
Hospital Juarez de Mexico
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
38
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
F(ab')2 antivenom plus local cryotherapy.Local cryotherapy.Group A: patients with a Crotalus snakebite, and grade II envenomation received F(ab')2 antivenom therapy and application of local cryotherapy.
F(ab')2 antivenom plus local cryotherapy.F(ab)2 antivenom therapy (antivipmyn®).Group A: patients with a Crotalus snakebite, and grade II envenomation received F(ab')2 antivenom therapy and application of local cryotherapy.
F(ab')2 antivenom.F(ab)2 antivenom therapy (antivipmyn®).Group B: patients who received only F(ab')2 antivenom therapy.
Primary Outcome Measures
NameTimeMethod
Distal circumference of the affected limb on hospital admission.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.

Proximal circumference of the affected limb on hospital admission.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.

Middle circumference of the affected limb on hospital admission.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 Outcome Measures
NameTimeMethod
Hospital stay.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.

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