Surgical site infection, especially in high risk
abdominal and colorectal surgery, is a constant
threat to patients and hospitals

Patients

Impact on Patients

Ssi Patients

3 out of 20 patients undergoing high-risk abdominal surgery will develop an infection.1, 2, 3

Median length of stay4; Readmission5; ICU admission6; Risk of death6

Hospitals

High Cost of High SSI Rates

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$10B spent annually treating SSI 7

Surture

Average cost per SSI $19,000 5, 8

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-$500k annual CMS penalty per hospital 9

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Negative publicity for the hospital

Lowering SSI rates, decreases the cost of care

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All Colorectal

Default value based on an average of the sub-group SSI incidence reported in 1-3

1. Watanabe A, Kohnoe S, Shimabukuro R, et al. Risk factors associated with surgical site infection in upper and lower gastrointestinal surgery. Surg Today. 2008;38(5):404-412.

2. Wick EC, Vogel JD, Church JM, Remzi F, Fazio VW. Surgical site infections in a "high outlier" institution: are colorectal surgeons to blame? Dis Colon Rectum. 2009;52(3):374-379.

3. Sutton E, Miyagaki H, Bellini G, et al. Risk factors for superficial surgical site infection after elective rectal cancer resection: a multivariate analysis of 8880 patients from the American College of Surgeons National Surgical Quality Improvement Program database. J Surg Res. 2017;207:205-214.

IBD

Default value based on an average of the sub-group SSI incidence reported in (1-3)

1. Bhakta A, Tafen M, Glotzer O, et al. Increased Incidence of Surgical Site Infection in IBD Patients. Dis Colon Rectum. 2016;59(4):316-322.

2. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg. 2004;239(5):599-605; discussion 605-597.

3. Uchino M, Ikeuchi H, Tsuchida T, Nakajima K, Tomita N, Takesue Y. Surgical site infection following surgery for inflammatory bowel disease in patients with clean-contaminated wounds. World J Surg. 2009;33(5):1042-1048.

Obese

Default value based on an average of the sub-group SSI incidence reported in (1-5)

1. Bhakta A, Tafen M, Glotzer O, et al. Increased Incidence of Surgical Site Infection in IBD Patients. Dis Colon Rectum. 2016;59(4):316-322.

2. Wick EC, Hirose K, Shore AD, et al. Surgical site infections and cost in obese patients undergoing colorectal surgery. Arch Surg. 2011;146(9):1068-1072.

3. Mik M, Berut M, Trzcinski R, Dziki L, Buczynski J, Dziki A. Preoperative oral antibiotics reduce infections after colorectal cancer surgery. Langenbecks Arch Surg. 2016;401(8):1153-1162.

4. Esemuede IO, Murray AC, Lee-Kong SA, Feingold DL, Kiran RP. Obesity, regardless of comorbidity, influences outcomes after colorectal surgery-time to rethink the pay-for-performance metrics? J Gastrointest Surg. 2014;18(12):2163-2168.

5. Silvestri M, Dobrinja C, Scomersi S, et al (2017) Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today

Diverticulitis

Default value based on an average of the sub-group SSI incidence reported in (1-2)

1. Bhakta A, Tafen M, Glotzer O, et al. Increased Incidence of Surgical Site Infection in IBD Patients. Dis Colon Rectum. 2016;59(4):316-322.

2. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg. 2004;239(5):599-605; discussion 605-597.

Diabetes

Default value based on an average of the sub-group SSI incidence reported in (1-5)

1. Bhakta A, Tafen M, Glotzer O, et al. Increased Incidence of Surgical Site Infection in IBD Patients. Dis Colon Rectum. 2016;59(4):316-322.

2. Ata A, Valerian BT, Lee EC, Bestle SL, Elmendorf SL, Stain SC. The effect of diabetes mellitus on surgical site infections after colorectal and noncolorectal general surgical operations. Am Surg. 2010;76(7):697-702.

3. Sehgal R, Berg A, Figueroa R, et al. Risk factors for surgical site infections after colorectal resection in diabetic patients. J Am Coll Surg. 2011;212(1):29-34.

4. McConnell YJ, Johnson PM, Porter GA. Surgical site infections following colorectal surgery in patients with diabetes: association with postoperative hyperglycemia. J Gastrointest Surg. 2009;13(3):508-515.

5. Silvestri M, Dobrinja C, Scomersi S, et al. Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today. 2017.

Stoma

Default value based on an average of the sub-group SSI incidence reported in (1-2)

1. Silvestri M, Dobrinja C, Scomersi S, et al. Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today. 2017.

2. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg. 2004;239(5):599-605; discussion 605-597.

Emergency

Default value based on an average of the sub-group SSI incidence reported in (1-5)

1. Watanabe M, Suzuki H, Nomura S, et al. Risk factors for surgical site infection in emergency colorectal surgery: a retrospective analysis. Surg Infect (Larchmt). 2014;15(3):256-261.

2. Bayar B, Yilmaz KB, Akinci M, Sahin A, Kulacoglu H. An evaluation of treatment results of emergency versus elective surgery in colorectal cancer patients. Ulus Cerrahi Derg. 2016;32(1):11-17.

3. Ata A, Valerian BT, Lee EC, Bestle SL, Elmendorf SL, Stain SC. The effect of diabetes mellitus on surgical site infections after colorectal and noncolorectal general surgical operations. Am Surg. 2010;76(7):697-702.

4. Pedroso-Fernandez Y, Aguirre-Jaime A, Ramos MJ, et al. Prediction of surgical site infection after colorectal surgery. Am J Infect Control. 2016;44(4):450-454.

5. Silvestri M, Dobrinja C, Scomersi S, et al. Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today. 2017.

† Estimations for SSI Rate for each Patient Population are determined via several references.

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IBD

Default value based on an average of the sub-group prevalence reported in (1-3)

1. Bhakta A, Tafen M, Glotzer O, et al. Increased Incidence of Surgical Site Infection in IBD Patients. Dis Colon Rectum. 2016;59(4):316-322.

2. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg. 2004;239(5):599-605; discussion 605-597.

3. CIRCE Final Clinical Study Report. Data on File at Prescient Surgical.

Obese

Default value based on an average of the sub-group prevalence reported in (1-5)

1. Wick EC, Hirose K, Shore AD, et al. Surgical site infections and cost in obese patients undergoing colorectal surgery. Arch Surg. 2011;146(9):1068-1072.

2. Mik M, Berut M, Trzcinski R, Dziki L, Buczynski J, Dziki A. Preoperative oral antibiotics reduce infections after colorectal cancer surgery. Langenbecks Arch Surg. 2016;401(8):1153-1162.

3. Esemuede IO, Murray AC, Lee-Kong SA, Feingold DL, Kiran RP. Obesity, regardless of comorbidity, influences outcomes after colorectal surgery-time to rethink the pay-for-performance metrics? J Gastrointest Surg. 2014;18(12):2163-2168.

4. Silvestri M, Dobrinja C, Scomersi S, et al. Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today. 2017.

5. CIRCE Clinical Study. Data on File at Prescient Surgical.

Diverticulitis

Default value based on an average of the sub-group prevalence reported in (1-3)

1. Bhakta A, Tafen M, Glotzer O, et al. Increased Incidence of Surgical Site Infection in IBD Patients. Dis Colon Rectum. 2016;59(4):316-322.

2. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg. 2004;239(5):599-605; discussion 605-597.

3. CIRCE Clinical Study. Data on File at Prescient Surgical.

Diabetes

Default value based on an average of the sub-group prevalence reported in (1-3)

1. Esemuede IO, Murray AC, Lee-Kong SA, Feingold DL, Kiran RP. Obesity, regardless of comorbidity, influences outcomes after colorectal surgery-time to rethink the pay-for-performance metrics? J Gastrointest Surg. 2014;18(12):2163-2168.

2. Silvestri M, Dobrinja C, Scomersi S, et al. Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today. 2017.

3. CIRCE Final Clinical Study Report. Data on File at Prescient Surgical.

Stoma

Default value based on an average of the sub-group prevalence reported in (1-3)

1. Silvestri M, Dobrinja C, Scomersi S, et al. Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today. 2017.

2. Smith RL, Bohl JK, McElearney ST, et al. Wound infection after elective colorectal resection. Ann Surg. 2004;239(5):599-605; discussion 605-597.

3. CIRCE Final Clinical Study Report. Data on File at Prescient Surgical.

Emergency

Default value based on an average of the sub-group prevalence reported in (1-3)

1. Bayar B, Yilmaz KB, Akinci M, Sahin A, Kulacoglu H. An evaluation of treatment results of emergency versus elective surgery in colorectal cancer patients. Ulus Cerrahi Derg. 2016;32(1):11-17.

2. Pedroso-Fernandez Y, Aguirre-Jaime A, Ramos MJ, et al. Prediction of surgical site infection after colorectal surgery. Am J Infect Control. 2016;44(4):450-454.

3. Silvestri M, Dobrinja C, Scomersi S, et al. Modifiable and non-modifiable risk factors for surgical site infection after colorectal surgery: a single-center experience. Surg Today. 2017.

‡ Total number of Colorectal Procedures is assumed to be 300. Number of Procedures in each Colorectal Subgroup is an estimated proportion of the Total Population based on several references.

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References

1. Papaconstantinou HT, Ricciardi R, Margolin D, et al. Impact of Novel Wound Protection Device on Observed vs. Expected Surgical Site Infection Rates Following Colectomy Using the National Surgical Quality Improvement Program Risk Calculator. Poster presented at: WSA 2017 Annual Meeting; 2017 Nov 4-6; Scottsdale, AZ.

§ Reduction in SSI is based on results from a clinical study.

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The Cause

Wound contamination is the primary cause of SSI.

Nearly 50 percent of abdominal incisions are contaminated during surgery.10 Controlling that contamination is a constant challenge.

Current technology does not adequately support infection control efforts to eliminate contamination, creating critical gaps that leave patients vulnerable to infection.

There are four common critical gaps in current technology.

Incomplete Antisepsis

Incomplete skin antisepsis introduces bacteria into the incision.11

Passive Wound Protection

Passive wound protection can't clear invading bacteria.

Disruptive Manual Irrigation

Disruptive manual irrigation can spread contamination.12

Prophylactic antibiotic concentrations can fall below effective levels.13

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Our Solution

Gain Control Over the Sources of SSI

Developed by surgeons and infection control experts, CleanCision is the first in a new class of advanced cleansing technologies designed to fight and defend against the most pervasive sources of surgical infection, enhancing current infection control bundles and and seamlessly integrating into surgical workflows.

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References

1 Watanabe A, Kohnoe S, Shimabukuro R, et al. Risk factors associated with surgical site infection in upper and lower gastrointestinal surgery. Surg Today. 2008;38(5):404-412.

2 Wick EC, Vogel JD, Church JM, Remzi F, Fazio VW. Surgical site infections in a "high outlier" institution: are colorectal surgeons to blame? Dis Colon Rectum. 2009;52(3):374-379.

3 Sutton E, Miyagaki H, Bellini G, et al. Risk factors for superficial surgical site infection after elective rectal cancer resection: a multivariate analysis of 8880 patients from the American College of Surgeons National Surgical Quality Improvement Program database. J Surg Res. 2017;207:205-214.

4 de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009;37(5):387-397.

5 Wick EC, Hirose K, Shore AD, et al. Surgical site infections and cost in obese patients undergoing colorectal surgery. Arch Surg. 2011;146(9):1068-1072.

6 Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999;20(11):725-730.

7 Scott RD. The Direct Medical Costs of Healthcare-Associated Infection in US Hospitals and the Benefits of Prevention. Centers for Disease Control and Prevention; March 2009.

8 Tanner J, Khan D, Aplin C, Ball J, Thomas M, Bankart J. Post-discharge surveillance to identify colorectal surgical site infection rates and related costs. J Hosp Infect. 2009;72(3):243-250.

9 Rau J. Latest Hospital Injury Penalties Include Crackdown On Antibiotic-Resistant Germs. 2016; https://khn.org/news/latest-hospital-injury-penalties-include-crackdown-on-antibiotic-resistant-germs/._Accessed January 29, 2018.

10 Fa-Si-Oen PR, Kroeze F, Verhoef LH, Verwaest C, Roumen RM. Bacteriology of abdominal wounds in elective open colon surgery: a prospective study of 100 surgical wounds. Clin Microbiol Infect. 2005;11(2):155-157.

11 Privitera GP, Costa AL, Brusaferro S, et al. Skin antisepsis with chlorhexidine versus iodine for the prevention of surgical site infection: A systematic review and meta-analysis. Am J Infect Control. 2017;45(2):180-189.

12 Anglen JO. Wound irrigation in musculoskeletal injury. The Journal of the American Academy of Orthopaedic Surgeons. 2001;9(4):219-226.

13 Markantonis SL, Kostopanagiotou G, Panidis D, Smirniotis V, Voros D. Effects of blood loss and fluid volume replacement on serum and tissue gentamicin concentrations during colorectal surgery. Clin Ther. 2004;26(2):271-281.