Vancomycin powder to reduce surgical site infection in spine surgery

Transcription

1 Vancomycin powder to reduce surgical site infection in spine surgery 2014/03/25 EBM Spine Fellow 林東儀

2 Post-Op infection in spine surgery Wound infection: 0.7% to 11.9% Infection rates of 2.8% to 6.0% for elective fusion with instrumentation (OKU10) Most occur within the first few weeks Late or latent infection OKU 10

3 Clinical presentations Pain is the most common presentation Fever; fatigue Wound discharge Lab data Image OKU 10

4 Risk factors; OKU 10 obesity smoking diabetes mellitus alcohol abuse malnutrition chronic steroid use prior infection revision surgery longer than 3 hours blood loss greater than 1.0 L

5 2013 非計畫性重返手術數量 三月四月五月六月七月八月九月十月十一月十二月 Epidural Hematoma 五月六月七月八月九月十月十一月十二月 Wound problem 五月六月七月八月九月十月十一月十二月 Implant problem 五月六月七月八月九月十月十一月十二月

6 Patient list

7 To Reduce SSI Pre OP evaluation In operating room Operation Post OP care

8 Decrease SSI Identify risk factor and correct underlying Prophylatic antibiotics - <60 minutes before incision - Cefa 2g in morbid obese pt, >86KG Preop screening MRSA/MSSA colonization and eradication Antiseptic Bath (chlorhexidine ) at the night before op No. of persons during an operation

9 Decrease SSI Decrease the opening and closing the door Cleaning the OR environment Antibiotic suture: significantly reduce bacterial load, and reduce infection rate Vancomycin powder significantly reduce SSI in spine Keep wound dry with dressing changes

10 Vancomycin power hot issue

11 Spine Journal 2014

12 Background IV cephalosporin as the standard prophylaxis IV vancomycin or clindamycin for b-lactam allergy IV vancomycin is effective against MRSA But not recommended to routinely use Systemic vancomycin prophylaxis increased the risk of SSIs in patients who did not carry MRSA in their noses Gupta K et al. Infect Control Hosp Epidemiol 2011

13 Background : routine IV VAN Vancomycin has relatively slow bactericidal activity against S. aureus does not cover gram-negative organisms Researchers are also concerned that vancomycinresistant organisms might emerge (VISA ; VRSA) Sakoulas et al J Clin Microbiol

14 Vancomycin powder applied to wounds easily inexpensive high local concentrations with low systemic levels not reported any serious complications renal failure hearing loss pseudarthrosis after spinal operations few current meta-analysis review Sweet et al Spine

15 Search strategy : update to May 9, 2013

16 Study characteristics 1 RCT (cardiac operation) Other 9: quasi-experimental or cohort study 10 studies, encompassed 5,888 surgical patients 8 studies : spinal surgery (5018)

17 Result: all studies local vancomycin powder was significantly protective against all SSIs 10 studies; pooled odds ratio [por] 0.19; 95% confidence interval [CI] ) deep incisional SSIs seven studies; por 0.23; 95% CI SSIs caused by S. aureus seven studies; por 0.22; 95% CI

18 Spinal operation studies Vancomycin powder significatnly against all SSI eight studies; por 0.16; 95% CI deep incisional SSIs five studies; por 0.18; 95% CI S. aureus SSIs five studies; por 0.11; 95% CI Funnel plots : more symmetric but evidence of publication bias

19 O Neill,2011, Spine J Adult posterior instrumented spinal fusion to treat traumatic injuries Controls: 54; VAN powder : 56 (division by surgeon, with hemovac) 1 g IV cefazolin within 1 hour of surgical incision followed by 1 g IV cefazolin every 8 hours for 1 day 1 g powder to the muscle, fascia, and subcutaneous tissue of the wound before closure SSI: Controls: 13% VAN: 0%

20 Rahman, 2011 Adult spinal deformity procedure Controls: 334 VAN powder: 586 (division by timing of OP; hemovac) g powder to the wound before closure g was applied onto the closed fascia Required operative irrigation and debridement Deep SSIs: Controls: 5% VAN: 0.7% Scoliosis Research Society 46th Annual Meeting & Course; September 14 17, 2011;

21 Sweet, 2011, Spine ***** Posterior instrumented thoracic and lumbar fusions Controls: 821 VAN powder: 911 (division by timing of OP) 1 g powder was applied to the deep and superficial portions of the wound before closure 1 g powder was mixed with bone graft Superficial; deep Deep SSIs: Controls: 2.6% VAN: 0.2%

22 Drug level from drain Serum vancomycin not detected in 80% of patients with a minimum sensitivity of 0.6 μg/ml 20% of patients with serum vancomycin level average 1.6 μ g/ml, (0.7 to 5.9) Post-OP day 1 Only 6% detectable vancomycin blood levels later MRSA: Vancomycin MICs in the range of 0.5 to 2 μg/ml

23 Heller, 2012 Posterior instrumented spinal arthrodesis Controls: 371 VAN powder: 371 (division by timing of OP) Bathing with chlorhexidine g powder (dose was based on wound size) before closure All SSIs: Controls: 4.4% ; VAN: 2.1% Deep SSIs: Controls: 2.4% ; VAN: 1.2% Deep Staphylococcal SSI: VAN: 0%

24 Pahys, 2013, JBJS(A) Posterior cervical spine procedure Controls: (1) control 483 (2) with alcohol foam 323 VAN powder + (2) : 195 s Deep SSIs: Controls: (1) 1.86% (2) 0.31% VAN: 0%

25 Strom, 2013, Spine Adult posterior cervical Fusion (lateral mass screw + pedicle screw at C7) Controls: 79 VAN powder: 92 (division by timing of OP) 1 g powder to the muscle, fascia, and subcutaneous tissue before closure Subfascial drains (+) All SSIs: Controls: 10.9%; VAN: 2.5% S. aureus SSIs: Controls: 6.5% ; VAN: 1.3%

26 Strom, 2013 Lumbar laminectomy and fusion ( + - instrumentation) Controls: 97 VAN powder: 156 (division by timing of OP) (Subfascial drains) 1 g powder of the wound before closure All SSIs: Controls: 11.3% VAN: 0% S. aureus SSIs: Controls: 6.2% VAN: 0%

27 Caroom, 2013, Spine Posterior cervical decompression and instrumentation for multilevel cervical spondylotic myelopathy Single surgeon Controls: 72 VAN powder: 40 1 g powder was applied to the wound before closure All SSIs: Controls: 15.3% VAN: 0% MRSA SSIs: Controls: 6.9% VAN: 0%

28 Effectiveness of local vancomycin powder All study: vancomycin powder significantly protective against all SSI, deep incision SSI or SSI caused by S. aures Spinal: the same (even stronger result)

29 Complications Did not report complications of vancomycin No post-op acute renal failure, hearing loss or other systemic complications Not associated with pseudarthrosis

30 Limitations Inconsistency in the SSI definitions Non; required OP; deep vs superficial Different follow-up times > one month to > two year Limitations due to study design The optimal dosage of vancomycin?? (0.5 to 2g) Evidence of publication bias

31 Conclusion Local administration of vancomycin powder appears to protect against SSIs deep incisional SSIs S. aureus SSIs 0% in ref (19); (24);(25) Large, high-quality studies needed

32 Future study and problem Prospective RCT with large patients number Standard protocol Standard SSI definition Complications evaluation ( nephrotoxicity, ototoxicity, pseudarthrosis or allergy?) Off-label use? The drainage?

33 Thank you