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

NCT ID: NCT06448078

Last Updated: 2024-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2022-02-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rib Fractures Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case group

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

Group Type ACTIVE_COMPARATOR

External chest wall fixator

Intervention Type DEVICE

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

Control group

No intervention will be made to the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

External chest wall fixator

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ege University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gizem Kececi Ozgur

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gizem Kececi Ozgur, MD

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ege University Faculty of Medicine

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29794759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7996614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31047683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16269301 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GKOzgur

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sensory Training in Distal Radius Fractures
NCT06894485 NOT_YET_RECRUITING NA