The Natural History of Human Stingray Injuries

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Robert J Katzer, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01685749
First received: September 11, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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.


Condition
Stingray Injury
Marine Envenomation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Incidence and duration of particular symptoms, medical evaluations, and treatment [ Time Frame: up to 30 days from the date of injury ] [ Designated as safety issue: No ]
    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.


Study Start Date: July 2012
Groups/Cohorts
Enrolled participants
The targeted study population will include all people at Seal Beach who have been identified by the Seal Beach Lifeguards to have been stung by a jellyfish over the course of one year who are adults or children whose parent or guardian is present at the time of the injury. Children and pregnant women are included in the group.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The targeted study population will include all people at Seal Beach who have been identified by the Seal Beach Lifeguards to have been stung by a stingray over the course of one year who are adults or children whose parent or guardian is present at the time of the injury. Children and pregnant women are included.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685749

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Robert Katzer, MD    714-456-5239    rkatzer@uci.edu   
Principal Investigator: Robert Katzer, MD         
Sub-Investigator: Carl Schultz, MD         
Sub-Investigator: Fareed Ahmed         
Sub-Investigator: Aspen Alotis         
Sub-Investigator: Chelsey Bithell         
Sub-Investigator: Helena Do         
Sub-Investigator: Anthony Khong         
Sub-Investigator: Michael Louthan         
Sub-Investigator: Hinal Patel         
Sub-Investigator: Allen Yang         
Sub-Investigator: Vincent Chang         
Sub-Investigator: Christopher Gilani         
Sub-Investigator: Anum Iqbal         
Sub-Investigator: Nooreen Khan         
Sub-Investigator: Vincent Lam         
Sub-Investigator: Jennifer Mogi         
Sub-Investigator: Felipe Moreno         
Sub-Investigator: Kevin Pham         
Sub-Investigator: Sohni Singh         
Sub-Investigator: Calvin Tan         
Sub-Investigator: Trang Tran         
Sub-Investigator: Samantha Wong         
Sub-Investigator: Nadia Zuabi         
Sub-Investigator: Philip Wan         
Sponsors and Collaborators
University of California, Irvine
  More Information

No publications provided

Responsible Party: Robert J Katzer, Emergency Medical Services Fellow, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01685749     History of Changes
Other Study ID Numbers: HS#2011-8620
Study First Received: September 11, 2012
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 01, 2014