Trial Outcomes & Findings for Topical Antibiotic Treatment for Spine Surgical Site Infection (NCT NCT02776774)
NCT ID: NCT02776774
Last Updated: 2019-08-13
Results Overview
The investigators will compare answers to survey questions about knowledge of IWA among a diverse surgeon population to assess the feasibility of a future RCT and need for additional evidence.
Recruitment status
COMPLETED
Target enrollment
91 participants
Primary outcome timeframe
Baseline
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
Intra-wound Antibiotics (IWA) Knowledge and Use
Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
|
|---|---|
|
Overall Study
STARTED
|
91
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age not captured in study
Baseline characteristics by cohort
| Measure |
Intra-wound Antibiotics (IWA) Knowledge and Use
n=91 Participants
Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
|
|---|---|
|
Completed a clinical fellowship
Yes
|
79 Participants
n=91 Participants
|
|
Completed a clinical fellowship
No
|
6 Participants
n=91 Participants
|
|
Completed a clinical fellowship
Currently in fellowship
|
3 Participants
n=91 Participants
|
|
Completed a clinical fellowship
Missing
|
3 Participants
n=91 Participants
|
|
Specialty
Neurological Surgery
|
18 Participants
n=91 Participants
|
|
Specialty
Orthopaedic Surgery
|
69 Participants
n=91 Participants
|
|
Specialty
Other
|
1 Participants
n=91 Participants
|
|
Specialty
Missing
|
3 Participants
n=91 Participants
|
|
Practice Type
Academic Center
|
42 Participants
n=91 Participants
|
|
Practice Type
Veterans Affairs Healthcare System
|
0 Participants
n=91 Participants
|
|
Practice Type
Physician Owned Group Practice
|
15 Participants
n=91 Participants
|
|
Practice Type
Community Health Center
|
0 Participants
n=91 Participants
|
|
Practice Type
Private Hospital
|
10 Participants
n=91 Participants
|
|
Practice Type
Solo/2 - Physician Practice
|
6 Participants
n=91 Participants
|
|
Practice Type
Group Practice, 3-5
|
4 Participants
n=91 Participants
|
|
Practice Type
Group Practice, 6-50
|
6 Participants
n=91 Participants
|
|
Practice Type
Group Practice, 50+
|
5 Participants
n=91 Participants
|
|
Practice Type
Other
|
0 Participants
n=91 Participants
|
|
Practice Type
Missing
|
3 Participants
n=91 Participants
|
|
Surgery Performance Location
Outpatient Surgery Center
|
0 Participants
n=91 Participants
|
|
Surgery Performance Location
Private Hospital
|
37 Participants
n=91 Participants
|
|
Surgery Performance Location
Public Hospital
|
8 Participants
n=91 Participants
|
|
Surgery Performance Location
Academic Center
|
40 Participants
n=91 Participants
|
|
Surgery Performance Location
Veterans Affairs Healthcare System
|
0 Participants
n=91 Participants
|
|
Surgery Performance Location
Other
|
1 Participants
n=91 Participants
|
|
Surgery Performance Location
Missing
|
5 Participants
n=91 Participants
|
|
Opinion: Is IWA use for spine procedures the "standard of care"?
Yes, for every spine procedure
|
9 Participants
n=91 Participants
|
|
Opinion: Is IWA use for spine procedures the "standard of care"?
Yes, but only for specific spine procedures
|
36 Participants
n=91 Participants
|
|
Opinion: Is IWA use for spine procedures the "standard of care"?
No
|
46 Participants
n=91 Participants
|
|
Opinion: How often should IWA for spine procedures be used in practice?
Routinely (75-100% of the time)
|
29 Participants
n=91 Participants
|
|
Opinion: How often should IWA for spine procedures be used in practice?
Selectively (<75% of the time)
|
49 Participants
n=91 Participants
|
|
Opinion: How often should IWA for spine procedures be used in practice?
Never
|
3 Participants
n=91 Participants
|
|
Opinion: How often should IWA for spine procedures be used in practice?
Don't know
|
9 Participants
n=91 Participants
|
|
Opinion: How often should IWA for spine procedures be used in practice?
Missing
|
1 Participants
n=91 Participants
|
|
Opinion: The scientific evidence supporting the use of IWA is:
Strong
|
15 Participants
n=91 Participants
|
|
Opinion: The scientific evidence supporting the use of IWA is:
Moderate
|
44 Participants
n=91 Participants
|
|
Opinion: The scientific evidence supporting the use of IWA is:
Weak
|
26 Participants
n=91 Participants
|
|
Opinion: The scientific evidence supporting the use of IWA is:
Evidence is non-existent
|
0 Participants
n=91 Participants
|
|
Opinion: The scientific evidence supporting the use of IWA is:
Don't know
|
4 Participants
n=91 Participants
|
|
Opinion: The scientific evidence supporting the use of IWA is:
Missing
|
2 Participants
n=91 Participants
|
|
Opinion: Do IWA reduce the risk of infection by:
More than half
|
31 Participants
n=91 Participants
|
|
Opinion: Do IWA reduce the risk of infection by:
About half
|
20 Participants
n=91 Participants
|
|
Opinion: Do IWA reduce the risk of infection by:
Less than half
|
16 Participants
n=91 Participants
|
|
Opinion: Do IWA reduce the risk of infection by:
No benefit
|
3 Participants
n=91 Participants
|
|
Opinion: Do IWA reduce the risk of infection by:
Don't know
|
20 Participants
n=91 Participants
|
|
Opinion: Do IWA reduce the risk of infection by:
Missing
|
1 Participants
n=91 Participants
|
|
Do you think a randomized trial on the use of IWA is needed?
Yes
|
71 Participants
n=91 Participants
|
|
Do you think a randomized trial on the use of IWA is needed?
No
|
19 Participants
n=91 Participants
|
|
Do you think a randomized trial on the use of IWA is needed?
Missing
|
1 Participants
n=91 Participants
|
|
Would you be willing to randomize your patients in a clinical trial on the use of IWA?
Yes
|
58 Participants
n=91 Participants
|
|
Would you be willing to randomize your patients in a clinical trial on the use of IWA?
No
|
32 Participants
n=91 Participants
|
|
Would you be willing to randomize your patients in a clinical trial on the use of IWA?
Missing
|
1 Participants
n=91 Participants
|
|
Do you use IWA in spine procedures for:
All patients
|
14 Participants
n=91 Participants
|
|
Do you use IWA in spine procedures for:
Some patients
|
74 Participants
n=91 Participants
|
|
Do you use IWA in spine procedures for:
No patients
|
2 Participants
n=91 Participants
|
|
Do you use IWA in spine procedures for:
Missing
|
1 Participants
n=91 Participants
|
|
When did you first start using IWA?
Less than 1 year ago
|
5 Participants
n=91 Participants
|
|
When did you first start using IWA?
1-4 years ago
|
49 Participants
n=91 Participants
|
|
When did you first start using IWA?
5 years ago or more
|
34 Participants
n=91 Participants
|
|
When did you first start using IWA?
Missing
|
3 Participants
n=91 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Spine surgeon opinion regarding if intra-wound antibotic use for spine procedures is the "standard of care"?
The investigators will compare answers to survey questions about knowledge of IWA among a diverse surgeon population to assess the feasibility of a future RCT and need for additional evidence.
Outcome measures
| Measure |
Intra-wound Antibiotics (IWA) Knowledge and Use
n=91 Participants
Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
|
|---|---|
|
Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery
Yes, for every spine procedure
|
9 Participants
|
|
Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery
Yes, but for only specific spine procedures
|
36 Participants
|
|
Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery
No
|
46 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Spine surgeons
The investigators will survey surgeons about their current use of intra-wound antibiotics for spine surgery
Outcome measures
| Measure |
Intra-wound Antibiotics (IWA) Knowledge and Use
n=91 Participants
Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
|
|---|---|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on no instrumentation procedures · Never
|
22 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on no instrumentation procedures · Sometimes
|
46 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on no instrumentation procedures · Often
|
6 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on no instrumentation procedures · Always
|
12 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on no instrumentation procedures · Missing
|
5 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on single level instrumentation procedure · Never
|
5 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on single level instrumentation procedure · Sometimes
|
31 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on single level instrumentation procedure · Often
|
13 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on single level instrumentation procedure · Always
|
37 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on single level instrumentation procedure · Missing
|
5 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on multilevel instrumentation procedures · Never
|
0 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on multilevel instrumentation procedures · Sometimes
|
19 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on multilevel instrumentation procedures · Often
|
18 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on multilevel instrumentation procedures · Always
|
49 Participants
|
|
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery
Use, IWA on multilevel instrumentation procedures · Missing
|
5 Participants
|
Adverse Events
Intra-wound Antibiotics (IWA) Knowledge and Use
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
Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H.,
Surgical Outcomes Research Center - SORCE
Phone: 206-744-4631
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place