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Prevention of Jellyfish Stings

Primary Purpose

Bites and Stings

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Safe Sea ™
Placebo
Sponsored by
Boulware, David R, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bites and Stings focused on measuring Jellyfish, Stings, Marine, Envenomation, Jellyfish stings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy volunteers planning on snorkeling for 30 to 45 minutes. Exclusion Criteria: Pregnancy Severe allergy to jellyfish Allergy to any topical dermatologic product

Sites / Locations

  • Dry Tortugas National Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Safe Sea

Placebo

Arm Description

Coppertone® SPF15 (Schering-Plough)

Outcomes

Primary Outcome Measures

Incidence of jellyfish stings

Secondary Outcome Measures

Occurrence of seabather's eruption
impact of body hair on jellyfish stings

Full Information

First Posted
June 17, 2005
Last Updated
April 24, 2023
Sponsor
Boulware, David R, MD
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1. Study Identification

Unique Protocol Identification Number
NCT00114894
Brief Title
Prevention of Jellyfish Stings
Official Title
Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boulware, David R, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field effectiveness is unknown. This is a field test to determine the real world effectiveness.
Detailed Description
Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. Clown fish inhabit within the tentacles of sea anemones, which have stinging cells similar to those of jellyfish, yet clown fish are not stung by the sea anemones. In controlled laboratory environments, the jellyfish sting inhibitor, Safe Sea™ when applied to volunteers' arms, prevented 100% of Chrysaora fuscescens stings and 70% of Chiropsalmus quadrumanus stings. Of the C. quadrumanus stings that occurred, their intensity was diminished. The field effectiveness is unknown. This is a field test to determine the real world effectiveness of Safe Sea to prevent jellyfish stings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bites and Stings
Keywords
Jellyfish, Stings, Marine, Envenomation, Jellyfish stings

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safe Sea
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Coppertone® SPF15 (Schering-Plough)
Intervention Type
Other
Intervention Name(s)
Safe Sea ™
Intervention Description
Safe Sea ™ applied one time at 2 mg/cm2 coverage
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Coppertone® SPF15 sunscreen(Schering-Plough) applied at 2 mg/cm2 body coverage
Primary Outcome Measure Information:
Title
Incidence of jellyfish stings
Time Frame
during recreational saltwater exposure (~30 min)
Secondary Outcome Measure Information:
Title
Occurrence of seabather's eruption
Time Frame
within 48 hours of saltwater exposure
Title
impact of body hair on jellyfish stings
Time Frame
after recreational saltwater exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers planning on snorkeling for 30 to 45 minutes. Exclusion Criteria: Pregnancy Severe allergy to jellyfish Allergy to any topical dermatologic product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Boulware, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dry Tortugas National Park
City
Key West
State/Province
Florida
ZIP/Postal Code
33041
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16706948
Citation
Boulware DR. A randomized, controlled field trial for the prevention of jellyfish stings with a topical sting inhibitor. J Travel Med. 2006 May-Jun;13(3):166-71. doi: 10.1111/j.1708-8305.2006.00036.x.
Results Reference
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Prevention of Jellyfish Stings

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