Trial Outcomes & Findings for A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure (NCT NCT01317095)
NCT ID: NCT01317095
Last Updated: 2018-02-14
Results Overview
The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
48 hours after surgery
Results posted on
2018-02-14
Participant Flow
Participant milestones
| Measure |
Rigid Fixation
Patients will have their sternum closed by rigid fixation using Starnalock plates.
Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
Wire Closure is the Intervention
Patients will have their sternum closed using stainless steel wires.
Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
41
|
|
Overall Study
COMPLETED
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
Baseline characteristics by cohort
| Measure |
Wire Closure is the Intervention
n=41 Participants
Patients will have their sternum closed using stainless steel wires.
Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
Rigid Fixation
n=39 Participants
Patients will have their sternum closed by rigid fixation using Starnalock plates.
Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 9 • n=5 Participants
|
65 years
STANDARD_DEVIATION 8 • n=7 Participants
|
65 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours after surgeryPopulation: Intubation time
The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure
Outcome measures
| Measure |
Rigid Fixation
n=39 Participants
Patients will have their sternum closed by rigid fixation using Starnalock plates.
|
Wire Closure
n=41 Participants
Patients will have their sternum closed using stainless steel wires.
|
|---|---|---|
|
Intubation Time
|
7 hours
Standard Deviation 5
|
9 hours
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 5 days after surgeryPopulation: Likert Pain Scale from 0-10 (0: no pain; 10:worst possible pain)
One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5.
Outcome measures
| Measure |
Rigid Fixation
n=39 Participants
Patients will have their sternum closed by rigid fixation using Starnalock plates.
|
Wire Closure
n=41 Participants
Patients will have their sternum closed using stainless steel wires.
|
|---|---|---|
|
Pain Scores.
Pain score on day1
|
2.3 score on a scale
Standard Deviation 3.1
|
2.8 score on a scale
Standard Deviation 3.4
|
|
Pain Scores.
Pain score on day2
|
2.2 score on a scale
Standard Deviation 2.7
|
2.0 score on a scale
Standard Deviation 2.7
|
|
Pain Scores.
Pain score on day3
|
0.5 score on a scale
Standard Deviation 1.4
|
0.8 score on a scale
Standard Deviation 1.7
|
|
Pain Scores.
Pain score on day4
|
0.5 score on a scale
Standard Deviation 1.8
|
1.7 score on a scale
Standard Deviation 3.4
|
|
Pain Scores.
Pain score on day5
|
0.2 score on a scale
Standard Deviation 1.0
|
0.4 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: ICU stayPopulation: Postoperative average intensive care unit stay (hours)
Length of postoperative intensive care unit stay.
Outcome measures
| Measure |
Rigid Fixation
n=39 Participants
Patients will have their sternum closed by rigid fixation using Starnalock plates.
|
Wire Closure
n=41 Participants
Patients will have their sternum closed using stainless steel wires.
|
|---|---|---|
|
Length of ICU Stay
|
51 hours
Standard Deviation 29
|
55 hours
Standard Deviation 44
|
SECONDARY outcome
Timeframe: Until hospital dischargePopulation: Postoperative length of hospital stay.
Postoperative length of hospital stay.
Outcome measures
| Measure |
Rigid Fixation
n=39 Participants
Patients will have their sternum closed by rigid fixation using Starnalock plates.
|
Wire Closure
n=41 Participants
Patients will have their sternum closed using stainless steel wires.
|
|---|---|---|
|
Postop Length of Hospital Stay.
|
7 days
Standard Deviation 4
|
8 days
Standard Deviation 7
|
Adverse Events
Wire Closure is the Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Rigid Fixation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wire Closure is the Intervention
n=41 participants at risk
Patients will have their sternum closed using stainless steel wires.
Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
Rigid Fixation
n=39 participants at risk
Patients will have their sternum closed by rigid fixation using Starnalock plates.
Sternalock Rigid Fixation: Patients will have their sternum closed by rigid fixation using Sternalock plates.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Deep sternal infection
|
0.00%
0/41
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Mortality
|
2.4%
1/41 • Number of events 1
|
0.00%
0/39
|
Other adverse events
Adverse event data not reported
Additional Information
Hitoshi Hirose, Professor of Surgery
Thomas Jefferson University
Phone: 2159556925
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place