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Topical Antibiotic Treatment for Spine Surgical Site Infection

Topical Antibiotic Treatment for Spine Surgical Site Infection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02776774
Enrollment
91
Registered
2016-05-18
Start date
2015-09-30
Completion date
2018-08-31
Last updated
2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Keywords

spine

Brief summary

There is considerable interest in using in-wound antibiotics (IWA) to prevent infection after spine surgery. An adequate evaluation of IWA is lacking and prior studies are limited by confounding and bias. This prospective study will enroll spine surgeons across the country to complete a survey about their knowledge, attitudes, and practices for using in-wound antibiotics.

Detailed description

Surgical site infection (SSI) after spine surgery is a devastating complication. Spine SSIs occur in as many as 40,000 people each year, causing considerable disability and resulting in re-operative costs of over $100,000. Even with the use of standard perioperative infection prevention techniques, SSIs occur as often as 3-5% depending on the surveillance technique and time-window used, with widespread variability between practice sites and surgeons. A mainstay of SSI prevention is the timely administration of antibiotics, but one of the limits of intravenous antibiotic prophylaxis is that bone tissue concentrations of antibiotics are lower than blood levels. As a result, there has been increasing interest in the use of in-wound antibiotics (IWA), placed directly on the spine at the completion of surgery. IWAs have been supported by several observational studies with a recent systematic review suggesting an 84% decrease in SSI. However, most of these studies failed to address important confounding in the ways IWA were used and had variable follow-up. The only IWA randomized controlled trial (RCT), albeit underpowered failed to identify a protective effect, leading to uncertainty about the role of IWA. Because of the relative infrequency of SSI, variable windows of follow-up and high rates of confounding in prior studies of IWA a large scale trial of IWA with an appropriate follow-up period is needed to evaluate its effectiveness in spine surgery. Such a trial would be more feasible if randomization occurred at the level of hospital cluster (cRCT), to account for existing variation in practices regarding IWA use, variable rates of SSI, and use of other SSI prevention techniques. Several pilot and feasibility questions need to be addressed before a cRCT of IWA can be proposed. SSI can appear as long as a year after spine surgery and short follow-up time in prior studies may have undercounted events and may have failed to recognize SSIs that may have been potentially delayed in detection because of the IWA. For example, the rationale for surgeon use of IWA, antibiotic type, or dose is unclear, as is whether surgeons use IWA in a similar fashion across patients and sites and if this represents confounding for which researchers must account. It is also unclear if surgeon use of IWAs is related to knowledge about existing data, beliefs and attitudes that may be barriers or enablers to a trial that promotes greater use of IWAs. To address these issues and direct an eventual cRCT, the investigators will perform surveys of spine surgeons assessing knowledge, behaviors and attitudes about IWA.

Interventions

None listed

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Currently practicing spine surgeon, performing at least 5 spine surgeries per year * Able to provide consent to participate in research * 18 years of age or older

Exclusion criteria

* Surgeon or other provider that no longer performs spine surgeries

Design outcomes

Primary

MeasureTime frameDescription
Surgeon Attitudes About Using Intra-wound Antibiotics for Spine SurgeryBaselineThe 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.

Secondary

MeasureTime frameDescription
Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryBaselineThe investigators will survey surgeons about their current use of intra-wound antibiotics for spine surgery

Countries

United States

Participant flow

Participants by arm

ArmCount
Intra-wound Antibiotics (IWA) Knowledge and Use
Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons.
91
Total91

Baseline characteristics

CharacteristicIntra-wound Antibiotics (IWA) Knowledge and Use
Age, Customized— Participants
Completed a clinical fellowship
Currently in fellowship
3 Participants
Completed a clinical fellowship
Missing
3 Participants
Completed a clinical fellowship
No
6 Participants
Completed a clinical fellowship
Yes
79 Participants
Do you think a randomized trial on the use of IWA is needed?
Missing
1 Participants
Do you think a randomized trial on the use of IWA is needed?
No
19 Participants
Do you think a randomized trial on the use of IWA is needed?
Yes
71 Participants
Do you use IWA in spine procedures for:
All patients
14 Participants
Do you use IWA in spine procedures for:
Missing
1 Participants
Do you use IWA in spine procedures for:
No patients
2 Participants
Do you use IWA in spine procedures for:
Some patients
74 Participants
Opinion: Do IWA reduce the risk of infection by:
About half
20 Participants
Opinion: Do IWA reduce the risk of infection by:
Don't know
20 Participants
Opinion: Do IWA reduce the risk of infection by:
Less than half
16 Participants
Opinion: Do IWA reduce the risk of infection by:
Missing
1 Participants
Opinion: Do IWA reduce the risk of infection by:
More than half
31 Participants
Opinion: Do IWA reduce the risk of infection by:
No benefit
3 Participants
Opinion: How often should IWA for spine procedures be used in practice?
Don't know
9 Participants
Opinion: How often should IWA for spine procedures be used in practice?
Missing
1 Participants
Opinion: How often should IWA for spine procedures be used in practice?
Never
3 Participants
Opinion: How often should IWA for spine procedures be used in practice?
Routinely (75-100% of the time)
29 Participants
Opinion: How often should IWA for spine procedures be used in practice?
Selectively (<75% of the time)
49 Participants
Opinion: Is IWA use for spine procedures the standard of care?
No
46 Participants
Opinion: Is IWA use for spine procedures the standard of care?
Yes, but only for specific spine procedures
36 Participants
Opinion: Is IWA use for spine procedures the standard of care?
Yes, for every spine procedure
9 Participants
Opinion: The scientific evidence supporting the use of IWA is:
Don't know
4 Participants
Opinion: The scientific evidence supporting the use of IWA is:
Evidence is non-existent
0 Participants
Opinion: The scientific evidence supporting the use of IWA is:
Missing
2 Participants
Opinion: The scientific evidence supporting the use of IWA is:
Moderate
44 Participants
Opinion: The scientific evidence supporting the use of IWA is:
Strong
15 Participants
Opinion: The scientific evidence supporting the use of IWA is:
Weak
26 Participants
Practice Type
Academic Center
42 Participants
Practice Type
Community Health Center
0 Participants
Practice Type
Group Practice, 3-5
4 Participants
Practice Type
Group Practice, 50+
5 Participants
Practice Type
Group Practice, 6-50
6 Participants
Practice Type
Missing
3 Participants
Practice Type
Other
0 Participants
Practice Type
Physician Owned Group Practice
15 Participants
Practice Type
Private Hospital
10 Participants
Practice Type
Solo/2 - Physician Practice
6 Participants
Practice Type
Veterans Affairs Healthcare System
0 Participants
Race and Ethnicity Not Collected— Participants
Specialty
Missing
3 Participants
Specialty
Neurological Surgery
18 Participants
Specialty
Orthopaedic Surgery
69 Participants
Specialty
Other
1 Participants
Surgery Performance Location
Academic Center
40 Participants
Surgery Performance Location
Missing
5 Participants
Surgery Performance Location
Other
1 Participants
Surgery Performance Location
Outpatient Surgery Center
0 Participants
Surgery Performance Location
Private Hospital
37 Participants
Surgery Performance Location
Public Hospital
8 Participants
Surgery Performance Location
Veterans Affairs Healthcare System
0 Participants
When did you first start using IWA?
1-4 years ago
49 Participants
When did you first start using IWA?
5 years ago or more
34 Participants
When did you first start using IWA?
Less than 1 year ago
5 Participants
When did you first start using IWA?
Missing
3 Participants
Would you be willing to randomize your patients in a clinical trial on the use of IWA?
Missing
1 Participants
Would you be willing to randomize your patients in a clinical trial on the use of IWA?
No
32 Participants
Would you be willing to randomize your patients in a clinical trial on the use of IWA?
Yes
58 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery

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.

Time frame: Baseline

Population: Spine surgeon opinion regarding if intra-wound antibotic use for spine procedures is the standard of care?

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intra-wound Antibiotics (IWA) Knowledge and UseSurgeon Attitudes About Using Intra-wound Antibiotics for Spine SurgeryYes, for every spine procedure9 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseSurgeon Attitudes About Using Intra-wound Antibiotics for Spine SurgeryYes, but for only specific spine procedures36 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseSurgeon Attitudes About Using Intra-wound Antibiotics for Spine SurgeryNo46 Participants
Secondary

Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery

The investigators will survey surgeons about their current use of intra-wound antibiotics for spine surgery

Time frame: Baseline

Population: Spine surgeons

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on no instrumentation proceduresNever22 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on no instrumentation proceduresSometimes46 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on no instrumentation proceduresOften6 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on no instrumentation proceduresAlways12 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on no instrumentation proceduresMissing5 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on single level instrumentation procedureNever5 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on single level instrumentation procedureSometimes31 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on single level instrumentation procedureOften13 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on single level instrumentation procedureAlways37 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on single level instrumentation procedureMissing5 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on multilevel instrumentation proceduresNever0 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on multilevel instrumentation proceduresSometimes19 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on multilevel instrumentation proceduresOften18 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on multilevel instrumentation proceduresAlways49 Participants
Intra-wound Antibiotics (IWA) Knowledge and UseDescribe Surgeon Practices for Using Intra-wound Antibiotics for Spine SurgeryUse, IWA on multilevel instrumentation proceduresMissing5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026