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Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

NCT04470791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Snake Bites

Interventions

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.

Sponsors & Collaborators

  • Hospital Juarez de Mexico

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-07-01
Completion
2017-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470791 on ClinicalTrials.gov