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Completed

NCT Number: NCT06448078

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.

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Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Medicine

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External chest wall fixator

Device

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

Primary outcomes

  1. Pain Level

    Time frame: 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.)

  2. Complications

    Time frame: 3 months

    Number of participants who developed complications

  3. Hospital Stay

    Time frame: 3 months

    Duration of hospital stay of patients (days)

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 7, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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