1. Comparative Effectiveness of Different Skin Antiseptic Agents in Reducing Surgical Site Infections Timo W. Hakkarainen, E. Patchen Dellinger, Rafael Alfonso-Cristancho Heather L. Evans Farhood Farjah, Ellen Farrokhi, Scott R. Steele, Richard Thirlby, David R. Flum, for the SCOAP Writing Collaborative

2. Background Surgical site infections (SSIs) occur in ~500K patients 4 Common Skin Anti-Septic Agents Chlorhexidine (CHG) Chlorhexidine in Alcohol (CHG+IPA) Povidone-Iodine (PVI) Iodine-povacrylex in Alcohol (IPC+IPA) Literature is limited Surrogate end-points Underpowered Different populations

3. Time-sequence methodology, N=3,209 0.59 RR for SSI iodophor+alcohol vs. CHG+IPA (p=0.001)

4. RCT, N=849 0.59 RR for SSI CHG+IPA vs. PVI (p=0.004)

5. Questions Why would skin-prep have such a large effect? Tschudin-Sutter et al. (2012) Pre-operative skin flora unrelated to pathogens isolated Is it appropriate to compare dual-agents to single? Maiwald and Chan (2012) Most studies ignored role of alcohol

6. Research Questions Comparative Effectiveness Role of Alcohol

7. Methods Prospective cohort Clinical data from index admission Setting: 47 SCOAP hospitals across WA State Timeframe: Jan 2011 through June 2012 Population: 8,014 patients 58% colorectal, 33% bariatric, 9% other

8. Age Gender Comorbidities ASA Class Smokers Low albumin Steroid Use Procedure Type Surgical Approach Procedure Duration Procedure Priority Hypothermia Hyperglycemia Length of Stay Significant differences between treatment arms… “Apples to Apples…” Risk Adjustment Propensity Analysis Restriction

9. Most differences between groups disappeared. Gender 5-10% fewer men in PVI group Smoking Status 5-9% more smokers in IPC+IPA group Surgical Approach 15-30% more open cases in PVI group Elective Colorectal Population

10. Observed-to-Expected Ratio SSI: All Cases

11. Observed-to-Expected Ratio SSI: Elective Colorectal Cases

12. Limitations Lack of Post-Discharge Data Our data appears similar to 7-10 day data presented by Darouiche et al. Population Differences Confounding Power

13. Conclusion & Discussion Our regional cohort finds no difference in rate of SSI based on skin-antiseptic agent. Effectiveness vs. Efficacy Reproducibility Recent studies in pharmaceutical literature have show reproducibility rates of between 11-25%

14. Acknowledgements The SCOAP Participating Hospitals The Surgical Care and Outcomes Assessment Program Writing Group Dr’s David Flum and E. Patch Dellinger NIH T-32 Training Grant 1T32DK070555-01A1

15. NSAIDS and Anastomotic Failure: A Report from Washington State’s SCOAP Timo W. Hakkarainen, E. Patchen Dellinger, Rafael Alfonso-Cristancho Amir Bastworous, Farhood Farjah, Ellen Farrokhi, Michael Florence, Scott Helton, Marc Horton, Michael Pietro, Scott R. Steele, Thomas Varghese, David R. Flum, for the SCOAP Collaborative

16. Disclosures No disclosures.

17. Background NSAIDs increasing use post-op “Better” side-effect profile ? impairment in GI healing

18. 4x increase in leak among NSAIDs group (p=0.15) Raised a flag 3 studies-n=1,372 all show increased risk

19. Objective Use the SCOAP platform to assess the relationship between post-operative NSAID use and anastomotic complications Real world Very large cohort Power to detect subtle differences Heterogeneity Emergency and elective cases Risk-adjusted outcomes and many process measures related to leaks

20. Methods Prospective data Medical records Index admission details then linked to CHARS for readmissions 47 SCOAP hospitals across WA State 2006-2010 13k+ patients undergoing GI surgery involving an anastomosis Bariatric, Colorectal Planned sub-population analyses Anastomotic leak (defined by related intervention)

21. CharacteristicNSAIDsNo NSAIDsp-value Age (mean)54.959.1<0.001 Charlson Index Score (mean)0.911.13<0.001 Albumin <3 (%)4.86.9<0.001 % Elective Procedures90.587.1<0.001 Results Patients receiving NSAIDs were younger, healthier, and underwent more elective procedures

22. PatientsNSAIDsNo NSAIDsp-value All4.8%4.2%0.16 Bariatric2.7%2.4%0.34 Elective Colorectal4.7%4.2%0.25 Non-Elective Colorectal12.3%8.3%<0.001 Crude Anastomotic Complication Rates

23. PatientsOR (95% CI)p-value All1.24 (1.01-1.56)0.04 Bariatric1.04 (0.53-2.06)0.89 Elective Colorectal1.13 (0.87-1.49)0.36 Non-Elective Colorectal1.70 (1.11-2.68)0.01 Risk of Anastomotic Leak with NSAIDs

24. Limitations Lack of agent, dose information Lack of pre-operative NSAID use information Inability to exclude those with NSAID allergy Lack of steroid use data

25. Conclusion Post-operative NSAIDs associated with anastomotic complications Main effect in non-elective colorectal surgery Observational data cannot be used for cause-effect Biologic plausibility Dose-effect relationships Temporal relationships Reversability of effect Future research is warranted to explore NSAID mechanism, formulation specific effects, and dose response

26. Take home Point NSAIDS may be a problem after surgery Given there are other non-opioid options for pain control these data may be enough for some to shift practice SCOAP community being alerted about findings and encouraged to consider the potential risks of NSAIDS after surgery in making treatment decisions

27. Acknowledgements The SCOAP Participating Hospitals The Surgical Care and Outcomes Assessment Program Writing Group Dr’s David Flum and E. Patch Dellinger NIH T-32 Training Grant 1T32DK070555-01A1