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

NCT06448078 | Completed Results

• 1 other identifier: GKOzgur
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures; Trauma

Keywords

rib fracture; external chest wall fixator; trauma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Case group

ACTIVE COMPARATOR

External chest wall fixator will be applied to the rib fracture area in the case group

Device: External chest wall fixator

Control group

NO INTERVENTION

No intervention will be made to the control group

Interventions

External chest wall fixator DEVICE

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

Case group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 29794759 BACKGROUND

• 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.

  PMID: 7996614 BACKGROUND

• 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.

  PMID: 31047683 BACKGROUND

• 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.

  PMID: 16269301 BACKGROUND

MeSH Terms

Conditions

Rib Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Thoracic Injuries

Results Point of Contact

• Title: Gizem Kececi Ozgur
• Organization: Ege University

gizem.kececi.1991@gmail.com

+90 506 678 71 28

Study Officials

• Gizem Kececi Ozgur, MD

  Ege University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Within the scope of the study, external fixator will be applied to 14 patients in the form of external bonding to the rib fracture area for 15 days, along with standard medical treatment. Standard medical treatment will be applied to 20 patients and these patients will constitute the control group.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 7, 2024
• Study Start: October 21, 2020
• Primary Completion: October 21, 2021
• Study Completion: February 17, 2022
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: The responsible researcher can be contacted via e-mail

Locations

TU (1)