Clinical trial NCT06448078: Comparative Evaluation of External Chest Wall Fixator Treatment Effectiveness in Patients With Rib Fractures
Official title: Comparative Evaluation of External Chest Wall Fixator Treatment Effectiveness in Patients With Rib Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rib Fractures
Trauma
Keywords: rib fracture
external chest wall fixator
trauma
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Level
timeFrame: 3 months
measure: Complications
timeFrame: 3 months
measure: Hospital Stay
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine
state: Bornova
Study officials:
affiliation: Ege University
name: Gizem Kececi Ozgur, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.