Comparative Evaluation of External Chest Wall Fixator Treatment Effectiveness in Patients With Rib Fractures

This study aimed to investigate the effect of external chest wall fixator on patients' pain level, complication development and hospital stay in patients with rib fractures.Patients who were admitted due to trauma and had serial rib fractures were evaluated. Standard treatment was applied to the control group. External chest wall fixator was applied to the case group in standard treatment. Pain levels of the patients, development of complications and duration of hospitalization were recorded.

Study Overview

• Status: Completed
• Conditions: Trauma; Rib Fractures
• Intervention / Treatment: Device: External chest wall fixator

Detailed Description

Basis of treatment for rib fractures is pain control and physiotherapy. External chest wall fixators may provide a new approach as part of multimodal treatment. This study aimed to investigate the effect of external chest wall fixator on patients' pain level, complication development and hospital stay in patients with rib fractures.

Patients who were admitted due to trauma and had serial rib fractures were evaluated. There were 14 patients in case group and 20 in control group. Standard treatment was applied to the control group. External chest wall fixator was applied to the case group in addition to standard treatment. Pain levels of the patients, development of complications and duration of hospitalization were recorded. Pain levels of the patients were evaluated using the Visual Analogue Scale and the pain level was scored between 0 and 10.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35100
      • Ege University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with serial rib fractures after trauma
• Patients without extrathoracic pathology

Exclusion Criteria:

• Patients with less than 3 rib fractures
• Patients with extrathoracic injuries
• Patients with bilateral rib fractures
• Patients with flail chest
• Patients with hemothorax or pneumothorax requiring drainage with tube thoracostomy at first admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Case group; External chest wall fixator will be applied to the rib fracture area in the case group	Device: External chest wall fixator; External chest wall fixator is applied in the form of external bonding to the rib fracture area
No Intervention: Control group; No intervention will be made to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	Pain level of patients on the 10th day, 1st month and 3rd month (Visual Analogue Pain Scale (VAS) will be used to assess pain level.Pain level will be scored between 1 and 10.Higher scores represent worse outcomes.)	3 months
Complications	Number of participants who developed complications	3 months
Hospital Stay	Duration of hospital stay of patients (days)	3 months

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Gizem Kececi Ozgur, MD, Ege University

Publications and helpful links

General Publications

• Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
• Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
• Martin TJ, Eltorai AS, Dunn R, Varone A, Joyce MF, Kheirbek T, Adams C Jr, Daniels AH, Eltorai AEM. Clinical management of rib fractures and methods for prevention of pulmonary complications: A review. Injury. 2019 Jun;50(6):1159-1165. doi: 10.1016/j.injury.2019.04.020. Epub 2019 Apr 22.
• Lee Y, Lee SH, Kim C, Choi HJ. Comparison of the effectiveness in pain reduction and pulmonary function between a rib splint constructed in the ER and a manufactured rib splint. Medicine (Baltimore). 2018 May;97(21):e10779. doi: 10.1097/MD.0000000000010779.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: trauma; rib fracture; external chest wall fixator
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures
• Other Study ID Numbers: GKOzgur

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data of the study will be shared if requested from the authors
• IPD Sharing Access Criteria: The responsible researcher can be contacted via e-mail
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No