NCT06680453

Brief Summary

In the 2010s, the practice of water sports was turned upside down by the arrival of a new discipline: foiling. The number of sailors, particularly amateurs, is increasing every every year. The foil offers greater speed and height, and has therefore the accidents and injuries that result. injuries. But there are very few studies on the subject. The TRAUMAF study proposes to compare the distribution of the number of patients injured during water sports with and without the use of foils. The study also looks at patient management and the type of injury. The aim is to anticipate the management of these patients during periods of practice of these sports. Translated with DeepL.com (free version)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 22, 2025

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

October 16, 2024

Last Update Submit

January 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the importance of foil-equipped craft in the occurrence of water-related injuries.

    Percentage of boating accidents involving foils.

    12 months

Secondary Outcomes (2)

  • Provide the doctor in charge of the patient with objective data on the most likely lesions and their potential severity.

    12 months

  • Analysis of the type and location of lesions observed between the foil and no-foil groups.

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any person of legal age, meeting the inclusion and non-inclusion criteria, presenting to an emergency department following a boating accident.

You may qualify if:

  • Patient of legal age
  • Patient not expressing refusal to participate in the study
  • Patient consulting an emergency room following a boating accident that occurred no more than 7 days previously
  • Patient able to complete a questionnaire

You may not qualify if:

  • Minor patient
  • Patients who are illiterate and/or do not understand French
  • Patient under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Brest

Brest, Finistère, 29609, France

RECRUITING

Centre Hospitalier Michel Mazéas

Douarnenez, Finistère, 29100, France

RECRUITING

Centre Hospitalier de Morlaix

Morlaix, Finistère, 29600, France

RECRUITING

Centre Hospitalier Intercommunal de Cornouaille

Quimper, Finistère, 29000, France

RECRUITING

GHBS Hôpital du Scorff

Lorient, Morbihan, 56100, France

RECRUITING

Central Study Contacts

Pierre-Yves Egreteau, Md

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2024

First Posted

November 8, 2024

Study Start

January 15, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 22, 2025

Record last verified: 2024-11

Locations