Topical Antibiotic Treatment for Spine Surgical Site Infection
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2017 |
| Start Date: | July 2015 |
| End Date: | July 2018 |
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.
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.
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.
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.
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
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