Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.

NCT04470791 | Completed DMC

• 1 other identifier: HJM 0142/16-R
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Snake Bites

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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

• 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.

• 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 Outcomes (1)

• Hospital stay.

  up to 24 weeks.

Study Arms (2)

F(ab')2 antivenom plus local cryotherapy.

EXPERIMENTAL

Group A: patients with a Crotalus snakebite, and grade II envenomation received F(ab')2 antivenom therapy and application of local cryotherapy.

Biological: F(ab)2 antivenom therapy (antivipmyn®).; Procedure: Local cryotherapy.

F(ab')2 antivenom.

ACTIVE COMPARATOR

Group B: patients who received only F(ab')2 antivenom therapy.

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

Interventions

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.

F(ab')2 antivenom plus local cryotherapy.; F(ab')2 antivenom.

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.

F(ab')2 antivenom plus local cryotherapy.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of the participants and interventionists was impossible, but the data analyst was blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized pilot study was performed that included patients of both genders and over 18 years old with a snakebite of envenomation grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: January 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share