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

Not Applicable

Completed

• Conditions: Trauma; Rib Fractures
• Interventions: Device: External chest wall fixator

• Registration Number: NCT06448078
• Lead Sponsor: Ege University

Brief Summary

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.

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 Timeline

• Study Start: 2020-10-21
• Primary Completion: 2021-10-21
• Study Completion: 2022-02-17
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-07
• Results First Submitted: 2024-06-26
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Results First Posted: 2024-11-08
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group	External chest wall fixator	External chest wall fixator will be applied to the rib fracture area in the case group

Primary Outcome Measures

Name	Time	Method
Pain Level	3 months	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.)
Complications	3 months	Number of participants who developed complications
Hospital Stay	3 months	Duration of hospital stay of patients (days)

Trial Locations

Locations (1)

Ege University Faculty of Medicine; 🇹🇷 İzmir, Bornova, Turkey