NCT04470791

Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Snake Bites

Interventions

Type	Name	Description
BIOLOGICAL	F(ab)2 antivenom therapy (antivipmyn®).	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.
PROCEDURE	Local cryotherapy.	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2020-07-14
• Last updated: 2024-02-28