Trial Outcomes & Findings for Comparative Evaluation of External Chest Wall Fixator Treatment Effectiveness in Patients With Rib Fractures (NCT NCT06448078)
NCT ID: NCT06448078
Last Updated: 2024-11-08
Results Overview
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.)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
3 months
Results posted on
2024-11-08
Participant Flow
Participant milestones
| Measure |
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
|
Control Group
No intervention will be made to the control group
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
20
|
|
Overall Study
COMPLETED
|
14
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Case Group
n=14 Participants
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
|
Control Group
n=20 Participants
No intervention will be made to the control group
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.50 years
STANDARD_DEVIATION 19.55 • n=14 Participants
|
52.50 years
STANDARD_DEVIATION 13.80 • n=20 Participants
|
55.38 years
STANDARD_DEVIATION 16.51 • n=34 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
16 Participants
n=20 Participants
|
26 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
14 participants
n=14 Participants
|
20 participants
n=20 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: first month pail 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.)
Outcome measures
| Measure |
Case Group
n=14 Participants
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
|
Control Group
n=20 Participants
No intervention will be made to the control group
|
|---|---|---|
|
Pain Level
|
1.79 score on a scale
Standard Deviation 0.80
|
2.85 score on a scale
Standard Deviation 1.53
|
PRIMARY outcome
Timeframe: 3 monthsNumber of participants who developed complications
Outcome measures
| Measure |
Case Group
n=14 Participants
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
|
Control Group
n=20 Participants
No intervention will be made to the control group
|
|---|---|---|
|
Complications
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 3 monthsDuration of hospital stay of patients (days)
Outcome measures
| Measure |
Case Group
n=14 Participants
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
|
Control Group
n=20 Participants
No intervention will be made to the control group
|
|---|---|---|
|
Hospital Stay
|
2.00 day
Standard Deviation 0.784
|
2.70 day
Standard Deviation 0.979
|
Adverse Events
Case Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place