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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Active Comparator | External chest wall fixator will be applied to the rib fracture area in the case group |
|
| Control group | No Intervention | No intervention will be made to the control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External chest wall fixator | Device | External chest wall fixator is applied in the form of external bonding to the rib fracture area |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gizem Kececi Ozgur, MD | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Faculty of Medicine | Izmir | Bornova | 35100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29794759 | Background | 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. | |
| 7996614 | 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. |
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The data of the study will be shared if requested from the authors
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The responsible researcher can be contacted via e-mail
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| ID | Title | Description |
|---|---|---|
| FG000 | Case Group | External chest wall fixator will be applied to the rib fracture area in the case group External chest wall fixator: External chest wall fixator is applied in the form of external bonding to the rib fracture area |
| FG001 | Control Group | No intervention will be made to the control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Case Group | External chest wall fixator will be applied to the rib fracture area in the case group External chest wall fixator: External chest wall fixator is applied in the form of external bonding to the rib fracture area |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.) | first month pail level | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Case Group | External chest wall fixator will be applied to the rib fracture area in the case group External chest wall fixator: External chest wall fixator is applied in the form of external bonding to the rib fracture area |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gizem Kececi Ozgur | Ege University | +90 506 678 71 28 | gizem.kececi.1991@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2020 | Jun 26, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2020 | Aug 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D013898 | Thoracic Injuries |
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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.
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Open label
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| 31047683 | 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. |
| 16269301 | 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. |
No intervention will be made to the control group |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | Complications | Number of participants who developed complications | Posted | Count of Participants | Participants | 3 months |
|
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| Primary | Hospital Stay | Duration of hospital stay of patients (days) | Posted | Mean | Standard Deviation | day | 3 months |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Control Group | No intervention will be made to the control group | 0 | 20 | 0 | 20 | 0 | 20 |
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