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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06448078
• Other study ID #: GKOzgur
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: February 17, 2022

Study information

• Verified date: June 2024
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 17, 2022
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures
• Trauma

Intervention

Device:
• External chest wall fixator
External chest wall fixator is applied in the form of external bonding to the rib fracture area

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Complications	Development of complications in patients (yes/no)	3 months
Primary	Hospital stay	Duration of hospital stay of patients (days)	3 months