Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

Snake Bites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470791
• Other study ID #: HJM 0142/16-R
• Secondary ID: HJM 0142/16-R
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: February 2024
• Source: Hospital Juarez de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Snake Bites

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal circumference of the affected limb on hospital admission.	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.	Baseline.
Primary	Proximal circumference of the affected limb on hospital admission.	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.	Baseline.
Primary	Middle circumference of the affected limb on hospital admission.	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.	Baseline.
Primary	Distal circumference of the affected limb on hospital admission.	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.	up to 24 weeks
Primary	Proximal circumference of the affected limb on hospital admission.	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.	up to 24 weeks.
Primary	Middle circumference of the affected limb on hospital admission.	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.	up to 24 weeks.
Secondary	Hospital stay.	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.	up to 24 weeks.