An interventional study of F(ab)2 antivenom therapy (antivipmyn®). and Local cryotherapy. in Snake Bites, sponsored by Hospital Juarez de Mexico. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Hospital Juarez de Mexico · Not applicable, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's enrollment of 38 is below the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →Hospital Juarez de Mexico is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Group B: patients who received only F(ab')2 antivenom therapy.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 24 weeks.
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.
Time frame: up to 24 weeks.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Jul 2017, 30 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Hospital Juarez de Mexico