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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02855060
Other study ID # 01-15-08B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date December 2018

Study information

Verified date July 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of pelvic binders in the ambulance setting improves outcomes including mortality in patients with pelvic fractures.


Description:

The goal of this prospective, randomized clinical trial is to determine whether prehospital use of a commercial pelvic binder will improve morbidity and mortality in patients with pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce hemorrhage and need for resuscitation and will improve overall mortality in patients with pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal femur fracture.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Traumatic injury other than ground-level fall, and - Complaint of pelvic groin or hip pain, or - Pelvic or hip deformity, ecchymosis, or crepitus in an obtunded patient, or - Hemodynamic instability Exclusion Criteria: - Ground level fall - Penetrating pelvis injury without frank evidence of fracture - Obviously pregnant patients - Patients who are too small or too big for the binder - Priority 2 or 3 Trauma

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pelvic Binder


Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Rate Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms 30 day
Secondary Pain Scores - Visual Analog Scale Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome. At time of arrival to Emergency Department
Secondary Number of Participants With Skin Complications After Pelvic Binder Application The rate of occurrence of skin complications after binder application will be documented. From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
Secondary Length of Stay in Hospital The total number of days the patient spent in the hospital From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
Secondary Number of Patients With Blood Transfusions Number of Blood Transfusions within the first 48 hours after hospital admission 48 hours
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