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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03314480
Other study ID # 201700304
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date June 1, 2021

Study information

Verified date May 2022
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim is to prospectively assess the association between clinical parameters and the presence of maxillofacial fractures in trauma patients admitted to the emergency department. Our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary produced CT scans in maxillofacial trauma patients.


Description:

The REDUCTION trial is a prospective multicentre cohort study conducted at the level I emergency departments of the University Medical Center Groningen, Isala hospital (Zwolle, The Netherlands) and the level II trauma center Nij Smellinghe hospital (Drachten, The Netherlands). The increased availability of Computed Tomography (CT) in the emergency department is leading to an overuse for patients with suspected maxillofacial injury. The use of a clinical decision aid could lead to more expedient use of diagnostic imaging within this population of patients. Therefore, all maxillofacial trauma patients admitted to the emergency department are included in this trial if the consultation is within 7 days after trauma. Both maxillofacial trauma patients admitted to CT scan and patients without a radiological confirmed diagnosis are included. The research protocol was approved by the institutional review board of the University Medical Center Groningen (Groningen, The Netherlands). Informed consent was waived as patients are treated according to the standards of care. Upon admission, each patient with maxillofacial injury will be allocated as a midfacial or mandibular trauma. During physical examination, either by the emergency physician or surgical resident, a pre-defined selection of clinical parameters will be assessed focussing on the assessment of potential presence of fractures in the maxillofacial region. The standardization of this examination will be ensured using a pocket map and easy accessible online instructional video's. The clinical parameters, fracture likelihood and physical examination findings will be structurally reported in electronic health record software using a smart tool dedicated for maxillofacial injury. Data regarding patient demographics, mechanism of injury, concomitant injury, diagnostic outcome and radiation dose parameters will be derived from the medical records.


Recruitment information / eligibility

Status Completed
Enrollment 1126
Est. completion date June 1, 2021
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - consultation within 7 days of trauma Exclusion Criteria: - history of maxillofacial surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Standardized physical examination
Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.

Locations

Country Name City State
Netherlands Nij Smellinghe ziekenhuis Drachten Friesland
Netherlands University Medical Center Groningen, University of Groningen Groningen
Netherlands Isala Diaconessenhuis Meppel Overijssel
Netherlands Isala ziekenhuis Zwolle Overijssel

Sponsors (3)

Lead Sponsor Collaborator
University Medical Center Groningen Isala, Nij Smellinghe Hosptial

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other CT time Time from admission to CT scanner Within 2 weeks from admission to the emergency department
Other Emergency department total time of admission Total time the patient was of admitted at the emergency department Within 2 weeks from admission to the emergency department
Primary Maxillofacial fracture The presence of either a maxillofacial or mandibular fracture induced by the trauma and diagnosed using CT or orthopantomography in the emergency department. Within 1 day, from admission to discharge from the emergency department
Secondary Treatment outcome The outcome of the treatment as determined by the Oral and Maxillofacial (OMF) surgeon or emergency physician classified as;
Admission and direct surgical treatment
Admission following elective surgery
Discharge following elective surgery
Discharge, expectative treatment and follow-up after seven days
Discharge, conservative treatment and follow-up after seven days
Discharge, conservative treatment, no follow-up
Within 2 weeks upon admission to the emegency department
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