Marine Envenomation Clinical Trial
Official title:
The Natural History of Human Stingray Injuries
Stingray injuries can be a hazard shared by many types of beachgoers. Stingrays often lie in
the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword,
resulting in a barbed stinger injecting venom into the victim. Little exists in the current
literature on the natural history of stingray injuries. Most of the existing literature
looks at the incidence of stings, and to a certain extent the demographic of people who seek
care. To our knowledge no study has attempted to collect a more inclusive population of
those people who are stung and follow them prospectively to determine the incidence of
medical intervention, infection, etc.
This study aims to describe and quantify the natural history of stingray injuries and to
better understand their time course and medical requirements. The study setting will be Seal
Beach, which reports some of the greatest number of annual stingray injuries for any single
beach on the pacific coast. Participants will be identified by the Seal Beach lifeguards who
are believed to treat the majority of stingray injuries suffered at the beach. Eligible
persons will be consented for participation over the phone by research personnel. If
enrolled in the study they will receive a phone call by research personnel one week and one
month after the injury that will collect information about the symptoms they have
experienced and the medical interventions they have received, if any. This study is strictly
observational in nature and will not involve any interventions on the part of study
personnel or alter the manner in which or types of medical assessments or treatments.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - People at Seal Beach, California - People identified by Life guard personnel as being stung by a stingray at Seal Beach - Adults or - Children whose parent or guardian are present at the time of the injury Exclusion Criteria: - People who have previously been enrolled in the study - People who the lifeguard believes were stung or bit by a marine organism other than a stingray or a terrestrial organism |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, Irvine Medical Center | Orange | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Irvine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence and duration of particular symptoms, medical evaluations, and treatment | This study is descriptive in nature. The primary outcome of this study is the understanding of the natural history of stingray injuries and their treatment. This will be achieved using strictly descriptive statistics of the incidence and duration of particular symptoms, medical evaluations, and treatment. Means, proportions, and confidence intervals of these statistics will be calculated. | up to 30 days from the date of injury | No |