Surgical site infection (SSI) after spine surgery is a devastating complication, now classified as a never event by payers, because it is presumed to be the result of a lapse in quality. Spine SSIs occur in as many as 40,000 people each year, resulting in considerable disability and costs to the system, with reoperations often over $100,000. Even with the use of standard perioperative infection prevention techniques, SSIs occur in as many as 3-5%. A mainstay of SSI prevention is antibiotic treatment, but because antibiotic concentrations are lower in bone tissue than blood levels, there has been increasing interest in the use of in-wound antibiotics (IWA), placed directly on the spine at the completion of surgery to advent spine SSI. Because of the relative infrequency of SSI and variation in IWA techniques at both the hospital- and surgeon-level, it remains to be determined if the broad use of IWA would actually decrease rates of spine SSI. A large scale trial of IWA with an appropriate follow-up period is needed to evaluate its effectiveness in spine surgery. Leveraging the Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP)-Comparative Effectiveness Research Translation Network (CERTAIN) network in conjunction with Washington's Comprehensive Hospital Abstract Reporting System, we will perform a set of studies that should support an appropriate trial of IWA. The accomplish this we propose:
Aim 1 : Test differences in the incidence of SSI at 30, 90, 180 and 360-days after spine fusion, overall and among those who do and do not receive IWA using a linked Spine SCOAP-CHARS dataset;
Aim 2 : Compare knowledge, beliefs and attitudes about IWA with the actual use of IWA by surgeons in Spine SCOAP-CERTAIN hospitals , and Aim 3: Assess willingness to take part in a future trial and design an efficient cRCT using Spine SCOAP-CERTAIN hospitals. This research brings together a truly multidisciplinary team of experts in spine surgery, comparative effectiveness research, public health, SSI prevention, cRCT biostatistics, epidemiology, patient-reported outcomes who have been working together for over 10 years. The results of this set of pilot and feasibility studies will support the design and conduct of a cRCT within the Spine SCOAP-CERTAIN network and/or inform other researchers considering such a trial. Ultimately, these studies should determine the effectiveness of adding IWA to standard infection prevention regimens to avoid SSI after spine surgery. Demonstrating that IWA is effective would represent a major shift in the practice of spine surgery and have direct benefits to thousands of patients each year.
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. We propose several pilot and feasibility studies that are necessary to support the conduct of a cluster randomized controlled trial (cRCT) of IWA. Conducted within Washington State's Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP)-Comparative Effectiveness Research Translation Network (CERTAIN) network, these studies will support a real-world trial that may change the practice of spine surgery, with great potential benefit to patients.
| Ehlers, Anne P; Khor, Sara; Shonnard, Neal et al. (2016) Intra-Wound Antibiotics and Infection in Spine Fusion Surgery: A Report from Washington State's SCOAP-CERTAIN Collaborative. Surg Infect (Larchmt) 17:179-86 |
