Vascular Incisions: Considerations for use with the Prevena Incision Management System

Transcription

1 Vascular Incisions: Considerations for use with the Prevena Incision Management System Charles Andersen MD, FACS, FAPWCA Clinical Prof of Surgery UW, USUHS Chief Vascular/Endovascular/ Limb Preservation Surgery Service Medical Director Wound Care Clinic, Madigan Healthcare System Lori Pounds, MD Associate Professor University of Texas Health Science Center San Antonio Chief Vascular Surgery Audie Murphy VAH 2012 KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

2 Important Information 2 Itis important for providers to consult the treating physician and read and understand all device Instructions for Use, including Safety Information. KCI recommends that clinicians participate in device in service and training prior to use. Follow local institutional protocols for infection control and waste disposal procedures. Local protocols should be based on the applicable federal, state and/orlocal government environmental regulations. The following slides include case studies based on clinical experience and research. As with any case study, the results and outcomes should not be interpreted as a guarantee or warranty of similar results. Individual results may vary depending on the patient s circumstances and condition. Scientific research was conducted by KCI employees and consultants. NOTE: Specific indications, contraindication, warnings, precautions and safety information exist for Prevena Therapy. Please consult the Prevena Clinician s Guide and product instructions for use prior to application. Rx only. All trademarks designated herein are proprietary to KCI Licensing, its affiliates and licensors KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

3 Objectives Identify complications with surgical incisions Review Scientific and clinical evidence supporting NPWT over various types of incisions Examine Prevena Incision Management System science and application with vascular incisions Review Cost-effectiveness data Case Studies KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

4 Overview Incision Management KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

5 Standard Closure Techniques for Surgical Incisions 2-6 Adjunctive Therapies used over Closure Techniques 7-15 Sutures Gauze dressings Staples Hydrocolloids Tissue adhesives *Growth factors Paper tape *Cultured skin Combination of the above Low energy ultrasound Silver Dressings NPWT KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

6 Complications of Surgical Incisions Seroma Hematoma Dehiscence Surgical Site Infection KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

7 Dehiscence the opening of a surgically closed wound due to stress, strain or infection 16 Surgical Site Infection A superficial incisional SSI must meet one of the following criteria: Infection occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the incision 16. Mosby's Medical Dictionary, 8th edition. 2009, Elsevier KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

8 Seromas and Hematomas Seroma Hematoma Definition: a clinically identifiable Definition: a collection of extravasated collection of serous fluid within a blood trapped in the tissues of the surgical cavity 18 skin or in an organ, resulting from Well-defined, localized areas of trauma or incomplete hemostasis swelling after surgery Tender to palpation and pressure Harden clot becomes palpable to the Adverse Outcomes: examiner Flap necrosis Painful for the patient Wound dehiscence 19, 20 Adverse Outcomes: Considerable blood loss Infection Woodworth P, McBoyle H, Helmer S and Beamer L, Seroma formation after breast cancer surgery: incidence and predicting factors. The America Surgeon, May 2000, 66 (5): Perkins JD, Patillo RA, How to avert postoperative wound complication and and treat it when it occurs, the journal of family practice, October 2009, Vol 21, No 10, downloaded from: Budd DC, Cochran RC, Sturtz DL, Fouty WJ: Surgical morbidity after mastectomy operations. Am J Surg 1978, 135: Aitkin DR, Minton JP: Complications associated with mastectomy. Surg Clin North Am 1983, 63: Mosby's Medical Dictionary, 8th edition. 2009, Elsevier KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

9 Prevalence of Hospital Acquired Infections CDC estimates of Healthcare Associated Infections (HAIs) 22 US 1.7 million infections US 99,000 deaths 17% to 22% are Surgical Site Infections (SSIs) Patients with multiple comorbidities are at higher risk for surgical site complications Obesity Diabetes Smoking Poor vascularization Poor nutrition 22. Health care acquired infections. Hospitals in pursuit of excellence 2010 January Klevens RM, Edwards JR, Richards C:, JR et al. Estimating health care associated infections and deaths in US hospitals, Public Health Rep 2007 March 1; 122(2): National Nonsocomial Infections Surveillance (NNIA) Report, data summary from October 1986-April 1996, issues May A report from the national nonsocomial infections surveillance system. AM J Infec Control 1996 October 1:24 (5): Scott RD, II. The direct medical costs of health care associated infections in US hospitals and the benefits of prevention. Atlanta, GA: Centers for Disease Control and Prevention; 2009 Mar Riou JP, Cohen FR, Johnson H, Jr. Factors influencing wound dehiscence. Am J Surg 1992 March 1; 163(3): Wilson JA, Clark JJ. Obesity: impediment to postsurgical wound healing. Adv Skin Wound Care 2004 October 1; 17(8): Abbas SM, Hill AG. Smoking is a major risk factor for wound dehiscence after midline abdominal incision; case control study. ANZ J Surg 2009 April 1; 79(4): KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

10 Surgical Site Infection Rates 29 Sternotomies - 0 to 3.72% C-sections to 7.53% Hysterectomies 1.36 to 5.17% Hip arthroplasty 0.86 to 2.52% Knee arthroplasty 0.88 to 2.26% 26% CDC Survey SSI rates National Nosocomial Infections Surveillance system report, data summary from January 1992 through June 2004, issued October Am J Infect Control 2004 December 1; 32 (8): KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

11 Collectively, deep incisional and organ space infections can be termed complex SSIs. Complex SSIs are serious infections that typically require rehospitalization, return to the operating room, and intravenous antibiotic therapy. 30. Complex Surgical Site Infections and the Devilish Details of Risk Adjustment: Important Implications for Public Reporting Deverick J. Anderson, MD, MPH, Luke F. Chen, MBBS, Daniel J. Sexton, MD and Keith S. Kaye, MD, MPH Infection Control and Hospital Epidemiology, Vol. 29, No. 10 (October 2008), pp Published by: The University of Chicago Press on behalf of The Society for Healthcare Epidemiology of America Article DOI: / KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

12 US Dehiscence Rates 31 Laparotomies 0.25 to 3.0% Cesarean section 1.6 to 42.3% Sternotomies 0.26 to 2.5% 31. Magann EF, Chauhan SP, Rodts Palenik S, Bufkin L, Martin JN, Jr., Morrison JC. Subcutaneous stitch closure versus subcutaneous drain to prevent wound disruption after cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol 2002 June 1; 186(6): KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

13 Risk Factors That May Compromise Healing Age >65 Hypoalbuminemia Malignancy Nicotine use Wound infection Systemic infection Hypertension Type of injury Pulmonary disease Obesity Length and depth of Radiation therapy incisioni i Peripheral vascular disease Uremia Anemia Steroid use Hemodynamic Hyperalimentation i Jaundice Malnutrition i instability Ostomies Ascites Diabetes poor control 26. Riou JP, Cohen JR, Johnson H, Jr. Factors influencing wound dehiscence. Am J Surg 1992 March 1;163(3): Wilson JA, Clark JJ. Obesity: impediment to postsurgical wound healing. Adv Skin Wound Care 2004 October 1;17(8): Abbas SM, Hill AG. Smoking is a major risk factor for wound dehiscence after midline abdominal incision; case-control study. ANZ J Surg 2009 April 1;79(4): KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13) 13

14 Author Study Type Patients Results/Conclusions JP Stannard et al Randomized Controlled (Journal of Trauma, Trial (interim analysis) 2006) VACTherapy vsstandard Post Operative Dressings JP Stannard et al Randomized Controlled (Abstract AAOS, Trial 2008) NPWT vs. Standard Postoperative Dressings (Control) High energy trauma wounds with draining hematomas (31 Control and 13 NPWT) High risk fractures (24 Control and 14 NPWT) 141 NPWT patients vs. 121 Control patients with calcaneus, pilon and tibial plateau fractures High energy trauma wounds: drained 1.6 days for NPWT vs. 3.1 days for Control (p=0.03) High risk fractures: drained days for NPWT vs. 48days 4.8 for Control (p=0.02) Study showed decreased drainage following both hematomas and severe fractures Significant difference in infection rate: 14 NPWT cases vs. 24 Control cases (p<0.02) Significant difference in incidence of dehiscence: 12 NPWT cases vs. 21 Control cases (p<0.03) AH Gommoll et al (Journal of Orthopedic Trauma 2006) Case Series V.A.C. Therapy (NPWT) 35 patients with foot and ankle trauma, revision hip arthroplasty, proximal femoral and tibial fracture fixation treated with NPWT BZ Atkins et al (Surgical Innovation 2009) Retrospective Review 57 adult sternal wound patients at high risk for infection i treated with ih NPWT Reddix et al (American Journal of Orthopedics, 2009) Reddix et al (Journal of Surgical Orthopedic Advances, 2010) Retrospective Review Retrospective Review NPWT vs. Standard Postoperative Dressings (Control) 19 morbidly obese patients (BMI>40) with acetabular fractures treated with NPWT 235 NPWT patients vs. 66 Control patients with acetabular fractures KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13) Average NPWT time: 3 days No infections occurred in these patients 3 months post operation Based on risk assessment, at least 3 sternal wound infections were anticipated but none were reported in the NPWT treated patients. NPWT was easy to apply and well tolerated No reported complications among these obese patients 235 patients with acetabular fractures treated with NPWT vs. 66 patients with acetabular fractures treated with standard postoperative care (Control) Deep wound infections: 3 (1.27%) NPWT vs. 4 (6.06%) Control Dehiscences: 1 (0.0426%) NPWT vs. 2 (3.03%) Control 1.27% infection rate represented a significant decrease compared to other similar size groups (reference rate = 4%; p=0.0282) Application of NPWT decreased the incidence of perioperative incision complications at the authors institution

15 Negative Pressure Therapy Designed for Clean Closed Incision Lines Prevena Incision Management System Indications for Use KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

16 Prevena Incision Management System KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

17 Prevena Incision Management System and Optimum Use Conditions The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Applied in OR To clean closed incisions 2-7 days The Prevena Incision Management System will not be effective in addressing complications associated with the following: Ischemia to the incision or incision area Untreated or inadequately treated infection Inadequate hemostasis of the incision Cellulitis of the incision area KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

18 Optimum Use Conditions The Prevena Incision Management System should not be used: To treat open or dehisced surgical wounds On patients who have excessive amounts of exudate (> 45mL ) The Prevena Incision Management System should be used with caution in the following patients: Patients with fragile skin surrounding the incision as they may experience skin or tissue damage upon removal of the Prevena Incision Dressing Patients who are at an increased risk of bleeding from the incision associated with the use of anticoagulants and/or platelet aggregation inhibitors Contraindications Sensitivity to Silver KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

19 Summary of Prevena Therapy System Warnings & Precautions * Please consult the Prevena System Clinician Guide and Instructions for Use for details on each of these Warnings and Precautions KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

20 Hands on Application Prevena System Application Always consult the Prevena Incision Management System Clinician Guide for use and detailed instructions prior to application found at this website: com/cs/satellite?c=page&childpagename=kci1%2fkcilayout&cid= &p= &packedargs=locale%3Den_US&pagename=KCI1Wrapper KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

21 Prevena System Application Overview Always consult the Prevena Incision Management System Clinician Guide for use and detailed instructions prior to application KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

22 Preparing for Prevena Dressing Application Clip or shave peri-incisional area of all hair pre-op where the dressing will be applied to improve dressing adhesion and seal integrity Clean and dry peri-incisional area post-operatively Be sure there are no drains under the dressing or drape While the concomitant use of surgical drains is allowable with the Prevena Therapy, the system must not be used as an outlet or reservoir for the drain. Do not cut or alter the dressing Do not bridge two units KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

23 Research Supporting Prevena Therapy Mechanism of Action Always consult the Prevena Incision Management System Clinician Guide for use and detailed instructions prior to application KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

24 Science of Incisional NPWT The following is a summary of scientific studies on Incisional NPWT Results have not been verified in human studies Findings are not to be considered as clinical claims KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

25 Impact of Prevena Incision Management System Immediate Intermediate Longer Term Impact Term Impact Impact KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

26 2D Finite Element Computer Modeling Showed Reduced d Lateral Tension Before Prevena Therapy With Prevena Therapy Lateral tension around suture line was reduced approximately 50% Immediate Impact Intermediate Term Impact Longer Term Impact 32. Wilkes et al., Surgical Innovations, KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

27 Bench Study of Appositional Forces Sutures/staples Incision Dressing footprint Load Load Loading plate Bonded area of loading plate pate Immediate Impact Intermediate Term Impact Longer Term Impact 32. Wilkes et al., Surgical Innovations, KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13) 28

28 In This Bench Top Model, Appositional Forces Were Increased Force required to stretch incision 10 mm p < 0.05 p < Force, N Without NP With NP 20 0 Sutured Incision Stapled Incision With Prevena Therapy: Suture line has 51% stronger approximation Staple line has 43% stronger approximation Immediate Impact Intermediate Term Impact Longer Term Impact 32. Wilkes et al., Surgical Innovations, KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

29 Immediate Impact Intermediate Term Impact Longer Term Impact KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

30 Porcine Incisions Following 5 Days of Prevena Therapy Immediate Impact Intermediate Term Impact Longer Term Impact 33. Yaszay B, Cavanaugh M, Kilpadi DK. Evaluation of Prevena Incision Dressing on the physical appearance of incisions. Sep , KCI Data on file KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

31 Porcine Incisions Following 5 Days of Prevena Therapy Incision i after 5 days Incision i following 5 days of treatment t t with Prevena Therapy Incision tensile strength trended 6-10 fold greater after 3 days of Prevena Therapy Data courtesy of Dr. Yaszay Immediate Impact Intermediate Term Impact Longer Term Impact KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

32 Mechanical Testing of Porcine Tissue 4 cm long full thickness dorsal incisions 2-0 Prolene (Ethicon, Inc.) interrupted suture closure 10 days of treatment: SOC (ABDs, chg Day 5) Prevena Therapy (5 days, chg to ABD) Sutures removed when healed No treatment from Day 10 to nx t = 0 sec t = 10 sec t = 20 sec t = 30 sec 35. Lessing et al., Poster presented at 2010 Wound Healing Society Annual Meeting, April KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13) 33

33 Summary of the Science Immediate Intermediate Longer Term Impact Term Impact Impact Decreased lateral tension Increased appositional strength Normalized stress distribution Improved Incisional quality (mechanical strength) Improved Incisional quality (histology) KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

34 Vascular Procedures Incident rate of surgical site complications Use of NPWT post surgery KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

35 Vascular Surgery - Surgical Site Infections Although uncommon surgical site infections associated with vascular grafts can be associated with significant morbidity and potential mortality KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

36 Vascular Surgical Site Complications SSI post arterial intervention most common nosocomial vascular infection Important cause of post operative morbidity Donor site considerations MRSA Gram positive Accounts for a third of the vascular SSI 46 Infection rates range from 1-20% Bandyk DF. Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg Sep;21(3): Review. PubMed PMID: KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

37 Predictors of surgical site infection after open lower extremity revascularization 48. Greenblatt David, Rajamanickam Victoria, Mell Matthew; Predictors of surgical site infection after open lower extremity revascularization. J Vasc Surg 2011;54: KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

38 Groin Incision Complications Additional considerations based on proximity to: Lymph glands Perineum Potential Complications Graft Infection may require removal Massive hemorrhage Systemic sepsis Severe limb ischemia i Septic embolization49, Atnip RG. Crossover ilioprofunda reconstruction: an expanded role for obturator foramen bypass. Surgery 1991; 110: [PubMed] 50. Patel KR, Semel L, Clauss RH. Routine revascularization with resection of infection femoral pseudoaneurysms from substance abuse. J Vasc Surg 1988;8: [PubMed] KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

39 Prevena Therapy with bilateral groin Incisions Intraoperative application of Prevena Therapy KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13) Incisions 7 days postoperatively after removal of Prevena Therapy

40 Experience with a New Negative Pressure Incision Management System in Prevention of Groin Wound Infection in Vascular Surgery Patients Tim Matatov, t MD, Kaavya N. Reddy, MD, Linda D. Doucet, RN, Cynthia X. Zhao, MD, Wayne W. Zhang, MD Division of Vascular and Endovascular Surgery, Louisiana State University Health Sciences Center, Shreveport, LA KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

41 LSU Prevena Therapy Retrospective Study Retrospective Chart Review 90 vascular patients with groin incisions 52 groin incisions in 41 patients treated with intraoperative application of Prevena Therapy 63 groin incisions in 49 patients treated with standard groin dressing Wounds were e evaluated at 7 and 30 days post operatively e KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

42 LSU Prevena Therapy Retrospective Study Prevena Therapy StandardGroin p value Dressing #of patients # of incisions Overall Infection 3 (6%) 19 (30% Szilagyi I 3 (6%) 10 (16%) Szilagyi II 0 7 (11%) Szilagyi III 0 2 (3%) KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

43 Potential Cost Effectiveness of Prevena Incision Management System over Groin Incisions in Vascular Surgery Patients Based on a Retrospective Review of 90 Consecutive Patients 1 Illustration of the Prevena Incision Management System cost effectiveness model based on Matatov outcomes 1 and Thomson cost data 2 Category Row Formula Patients 1 (A) % Infection 1 (B) 6% 30% Extrapolated Infections 2 (C) A * B 3 15 Prevena Therapy Non Prevena Cost Difference 7 Incremental Cost of Infection 3 (D) $37,274 $37,274 Total Infection cost 4 (E) C * D $111,822 $559,110 $447,288 Cost of Therapy 3 $495/wk Prevena Therapy $45.83/wk Non Prevena Therapy (F) $495 * A $45.83 * A $24,750 $2,292 ($22,459) Total Cost 5 (G) E + F $136,572 $561,402 $424,830 Total Cost per patient 6 (H) G / A $2,731 $11,228 $8,497 Potential Per Incision Savings Using Prevena Therapy 8 (I) $8,497 1 Tim Matatov, MD Kaavya N. Reddy, MD et. al, Poster: Experience with New Negative Pressure in Incision Management System in Prevention of Groin Wound Infection in Vascular Surgery Patients. Presented at Wound Ostomy and Continence Conference, June 9-13, 2012, Charlotte, NC. 2 Extrapolated Infections are calculated at same percent as in the study 6% for Prevena Therapy and 30% for Non-Prevena 3 Market Research National Level Report. Data from the Marketscan Projected Inpatient, Hospital Drug and Medpar Databases: Calendar Year New York, NY: Thomson Reuters; 2009 Oct 1 Incremental cost of infection is based on a national average of all patients with ICD other shunt and vascular bypass and a co-occurring complication of infection. Total Infection Cost Calculation: Prevena Therapy ($37,274*3= $111,822); Non-Prevena ($37,274*15 = $559,110) 4 Prevena Therapy cost of $495 is 2010 average U.S. price for 7 days of therapy with the Prevena Incision Management System; Non-Prevena therapy of Dermabond is changed once a week at $45.83 ($275/6 for 6 vials) 4 Total Cost Calculation: Prevena Therapy ($111,822+$25,740)= $136,572); Non-Prevena ($559,110+$2,292)= $561,402); 5 Total Cost per Patient: Prevena Therapy ($136,572/50)= $2,731.44); Non-Prevena ($561,402/50)= $11,228.03) 7 Cost Difference Calculation: Control Costs KCI Prevena Therapy Costs 8 Potential Per Patient Savings Calculation: ($11, $2, = $8,496.59) KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13) 46

44 Potential Cost Effectiveness of Prevena Incision Management System over Groin Incisions in Vascular Surgery Patients Based on a Retrospective Review of 90 Consecutive Patients 1 RESULTS: By reducing number of infections from 30% to 6% in this study population, the model indicated potential savings of $8,497 per patient treated with Prevena Incision Management System in this study KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13) 47

45 Clinical Cases and Experience Dr. Lori Pounds NOTE: As with any case study, the results and outcomes of this patient should not be interpreted as a guarantee or warranty of similar results. Individual results may vary depending on the patient s circumstances and condition. NOTE: Specific indications, contraindications, precautions and safety tips exist for this product and therapy. Please consult a physician, product instructions, and safety tips prior to application KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

46 What we are trying to avoid Fem Pop re-rupture V.A.C. Therapy; GranuFoam Dehiscence Dressing was put directly on skin causing irritation KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

47 Groins with multiple previous surgeries 67 y/o diabetic male pre-op with multiple previous incisions 62 y/o male pre-op multiple vascular surgery interventions KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

48 67 y/o Male Aortobifemoral bypass in diabetic smoker Prevena Therapy placed intraoperatively on both groin incisions for 5 days, pictures at 5 Days KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

49 Below Knee Amputation from a foot infection 48 yo uncontrolled diabetic that presented with a foot infection requiring BKA. Flap dehiscence with prolonged wound care and prevention of prosthesis combined with prolonged immobilization KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

50 2 BKAs post 5 days treatment with Prevena Therapy: Minimal i Edema 62 y/o male diabetic ESRD. Prevena Therapy for 4 days. 75 y/o diabetic male AKA day 5 Mild desquamination with Prevena Therapy KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

51 Prevena Therapy fits well on a standard below knee amputation incision KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

52 67 yo male diabetic ESRD with non-healing ischemic i wound Post BKA and after 5 days treatment with Prevena Therapy: no edema or infection KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

53 Bulbous above knee amputation treated with Prevena Therapy for 5 days 69 y/o diabetic male with gangrene foot pod 4 AKA KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

54 72 yo Male blew out femoral artery and required an obturator t bypass 57

55 Patient required ABF then fem pop with vein then required a revision of the vein graft Intra operative placement of Prevena Therapy 58

56 QUESTIONS KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

57 References Easterlin B, Bromberg W, Linscott J. A novel technique of vacuum assisted wound closure that functions as a delayed primary closure. Wounds 2007 December 1;19(12): Steichen FM, Ravitch MM. Mechanical sutures in surgery. Br J Surg 1973 March 1;60(3): Reece TB, Maxey TS, Kron IL. A prospectus on tissue adhesives. Am J Surg 2001 August 1;182(2 Suppl):40S-4S. 5. Coulthard P, Esposito M, Worthington HV, et al. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev 2010 May 12;5:CD Atkinson JA, McKenna KT, Barnett AG, et al. A randomized, controlled trial to determine the efficacy of paper tape in preventing hypertrophic scar formation in surgical incisions that traverse Langer's skin tension lines. Plast Reconstr Surg 2005 November 1;116(6): Holm C, Petersen JS, Gronboek F, et al. Effects of occlusive and conventional gauze dressings on incisional healing after abdominal operations. Eur J Surg 1998 March 1;164(3): (3) Wu L, Mustoe TA. Effect of ischemia on growth factor enhancement of incisional wound healing. Surgery 1995 May 1;117(5): Veves A, Falanga V, Armstrong DG,, et al. Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care 2001 February 1;24(2): Ennis WJ, Formann P, Mozen N, et al. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study. Ostomy Wound Manage 2005 August 1;51(8): Stannard JP, Robinson JT, Anderson ER,, et al. Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. J Trauma 2006 June 1;60(6): Stannard JP, Volgas DA, McGwin G, III et al. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma 2012 January 1;26(1): Atkins BZ, Wooten MK, Kistler J,, et al. Does negative pressure wound therapy have a role in preventing poststernotomy wound complications? Surg Innov 2009 June 1;16(2): Armstrong DG, Lavery LA, Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet 2005 November 12;366(9498): Blume PA. Comparison of Negative Pressure Wound Therapy Using Vacuum-Assisted Closure With Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers: a Multicenter Randomized Controlled Trial: Response to Hemkens and Waltering. Diabetes Care 2008 October 1;31(10):e Mosby's Medical Dictionary, 8th edition. 2009, Elsevier Woodworth P, McBoyle H, Helmer S, et al. Seroma formation after breast cancer surgery: incidence and predicting factors. The America Surgeon, May 2000, 66 (5): Perkins JD, Patillo RA. How to avert postoperative wound complication and i treat it when it occurs, the journal of family practice, October 2009, Vol21 21, No 10, downloaded d d from: Budd DC, Cochran RC, Sturtz DL, et al. Surgical morbidity after mastectomy operations. Am J Surg 1978, 135: Aitkin DR, Minton JP: Complications associated with mastectomy. Surg Clin North Am 1983, 63: Mosby's Medical Dictionary, 8th edition. 2009, Elsevier. 22. Health care acquired infections. Hospitals in pursuit of excellence 2010 January KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

58 References 23. Klevens RM, Edwards JR, Richards C, JR, et al. Estimating health care associated infections and deaths in US hospitals, Public Health Rep 2007 March 1; 122(2): National Nonsocomial Infections Surveillance (NNIA) Report, data summary from October 1986-April 1996, issues May A report from the national nonsocomial infections surveillance system. AM J Infec Control 1996 October 1:24 (5): Scott RD, II. The direct medical costs of health care associated infections in US hospitals and the benefits of prevention. Atlanta, GA: Centers for Disease Control and Prevention; 2009 Mar Riou JP, Cohen FR, Johnson H, Jr. Factors influencing wound dehiscence. Am J Surg 1992 March 1; 163(3): Wilson JA, Clark JJ. Obesity: impediment to postsurgical wound healing. Adv Skin Wound Care 2004 October 1; 17(8): Abbas SM, Hill AG. Smoking is a major risk factor for wound dehiscence after midline abdominal incision; case control study. ANZ J Surg 2009 April 1; 79(4): National Nosocomial Infections Surveillance system report, data summary from January 1992 through June 2004, issued October Am J Infect Control 2004 December 1; 32 (8): Complex Surgical Site Infections and the Devilish Details of Risk Adjustment: Important Implications for Public Reporting. Deverick J. Anderson, MD, MPH, Luke F. Chen, MBBS, Daniel J. Sexton, MD and Keith S. Kaye, MD, MPH Infection Control and Hospital Epidemiology, Vol. 29, No. 10 (October 2008), pp Magann EF, Chauhan SP, Rodts Palenik S, et al. Subcutaneous stitch closure versus subcutaneous drain to prevent wound disruption after cesarean delivery a randomized clinical trial. Am J Obstet Gynecol 2002 June 1; 186(6): Wilkes RP, Kilpadi DV, Zhao Y, Kazala R, McNulty A. Closed Incision Management With Negative Pressure Wound Therapy (CIM): Biomechanics. Surgical Innovation Mar;19(1): Epub 2011 Aug 25. Yaszay B, Cavanaugh M, Kilpadi DK. Evaluation of Prevena Incision Dressing on the physical appearance of incisions. Sep , KCI Data on file. (US Monograph, Ref. #51) 33. Kilpadi DV, Cunningham M. Evaluation of lymph involvement upon application of Prevena Incision Management in a porcine model. Wound Rep Reg (2011). 34. Lessing, Chris, Stock, Kimberly and Deepak Kilpadi et al. Poster presented at Symposium on Advanced Wound Care, October 13-15, 2011, Las Vegas, NV 36. Epstein AJ, Polsky D, Yang F, et al. Coronary Revascularization Trends in the United States, JAMA, 2011; 305 (17): DOI: /jama Atkins BZ, Wooten MK, Kistler J, Hurley K, Hughes GC, Wolfe W. Does negative pressure wound therapy have a role in preventing poststernotomy wound complications? Surgical Innovation Jun;16(2): Epub 2009 May Colli A. First experience with a new negative pressure Therapy on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg 2011 December 6;6(1): Opøien HK, Valbø A, Grinde-Andersen A, et al. (2007), Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstetricia et Gynecologica Scandinavica, 86: doi: / Bandyk DF. Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg Sep;21(3): Review. PubMed PMID: Greenblatt D, Rajamanickam Vi, Mell M. Predictors of surgical site infection after open lower extremity revascularization. J Vasc Surg 2011;54: Atnip RG. Crossover ilioprofunda reconstruction: an expanded role for obturator foramen bypass. Surgery 1991; 110: [PubMed] 45. Patel KR, Semel L, Clauss RH. Routine revascularization with resection of infection femoral pseudoaneurysms from substance abuse. J Vasc Surg 1988;8: [PubMed] 46. Stannard JP, Robinson JT, Anderson ER, et al. Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. J Trauma 2006 June 1;60(6): Armstrong DG, Lipsky BA. Diabetic foot infections: stepwise medical and surgical management. Int Wound J 1(2):123-32, Stannard JP, et al. Use of negative pressure therapy on closed surgical incisions: a case series. Ostomy Wound Manage. 2009;55: KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)

59 References 49. AH Gommoll et al (J Orthop Trauma 2006 November 1;20(10):705-9) 50. National volumes from 2003 National Hospital Discharge Survey data OSHPD data. Datasets use ICD-9-CM codes Hansen AD, Rand JA. Evaluation and treatment of infection at the site of a total hip or knee arthroplasty. J Bone Joint Surg Am. 1998; 80(6): Spangehl MJ, Masri BA, Oconnell JX, Duncan CP. Prospective analysis of preoperative and intraoperative investigations for the diagnosis of infection at the sites of two hundred and two revision total hip arthroplasties. JBone Joint Surg Am. 1999; 81(5): Reddix et al (Am J Orthop 2009 September 1; 38(9): 32-5) 55. Reddix et al (J Surg Orthop Adv 2010 June 1;19(2):91-7) 56. Pachowsky et al (Int Orthop 2011 E-pub July 15) KCI Licensing, Inc. All rights reserved. DSL# W (Rev 1/13)