Rib Fractures, Trauma
Conditions
Keywords
rib fracture, external chest wall fixator, trauma
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.
Interventions
DEVICEExternal chest wall fixator
External chest wall fixator is applied in the form of external bonding to the rib fracture area
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | 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.) |
| Complications | 3 months | Number of participants who developed complications |
| Hospital Stay | 3 months | Duration of hospital stay of patients (days) |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Control Group No intervention will be made to the control group | 20 |
| Total | 34 |
Baseline characteristics
| Characteristic | Control Group | Total | Case Group |
|---|---|---|---|
| Age, Continuous | 52.50 years STANDARD_DEVIATION 13.8 | 55.38 years STANDARD_DEVIATION 16.51 | 59.50 years STANDARD_DEVIATION 19.55 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Turkey | 20 participants | 34 participants | 14 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 26 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 20 |
| other Total, other adverse events | 0 / 14 | 0 / 20 |
| serious Total, serious adverse events | 0 / 14 | 0 / 20 |
Outcome results
Primary
Complications
Number of participants who developed complications
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Case Group | Complications | 2 Participants |
| Control Group | Complications | 8 Participants |
Primary
Hospital Stay
Duration of hospital stay of patients (days)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Case Group | Hospital Stay | 2.00 day | Standard Deviation 0.784 |
| Control Group | Hospital Stay | 2.70 day | Standard Deviation 0.979 |
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.)
Time frame: 3 months
Population: first month pail level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Case Group | Pain Level | 1.79 score on a scale | Standard Deviation 0.8 |
| Control Group | Pain Level | 2.85 score on a scale | Standard Deviation 1.53 |