Post-surgical V.A.C. VeraFlo Therapy with Prontosan Instillation on Inpatient Infected Wounds * COLLECTION OF CASE STUDIES

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1 COLLECTION OF CASE STUDIES Post-surgical V.A.C. VeraFlo Therapy with Prontosan Instillation on Inpatient Infected Wounds * *All patients were treated with systemic antibiotics

2 Post-surgical V.A.C. VeraFlo Therapy with Prontosan Instillation on Inpatient Infected Wounds * The following case studies are based on the physician s individual 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. Background Patients that presented with wound infections requiring hospital admission were given parenteral antibiotics at admission. During the initial visit to the operating room (OR), the following were performed: predebridement cultures, debridement, pulsatile irrigation, and postdebridement cultures. A subsequent visit to the OR was based on the clinical appearance and postdebridement culture results. If cultures were negative, the wound was either closed or covered with bioengineered alternative tissues, split thickness skin graft, local flap, or free flap, and the patient was subsequently discharged. If cultures were positive, the wound was redebrided. The culture method involved swabbing the deepest margins of the wound. Four streaks were created on an agar medium with the swab. Qualitative cultures were determined through growth on the medium. The sensitivities were then tested on the growth that occurred. The definitions of the findings were as follows: No growth: No growth on all 4 streaks Rare: Less than 1 complete streak of growth Few: 1 streak of growth Moderate: 2 streaks of growth Many: 3-4 streaks of growth Although qualitative cultures may be a less precise method for assessing bacterial infection, this method is considered the standard of care utilized throughout clinics and hospitals in the U.S. Below are three cases where the V.A.C.Ulta Negative Pressure Wound Therapy System was applied using V.A.C. VeraFlo Therapy with Prontosan Instillation between OR debridements. *All patients were treated with systemic antibiotics V.A.C.Ulta Therapy System: Collection of Case Studies

3 Clinical Case 1 Patient was a 59-year-old male with a history of Type II diabetes mellitus (DM), peripheral vascular disease (PVD), and peripheral neuropathy. Diagnosis: Patient presented with cellulitis, abscess, and osteomyelitis of the proximal and distal phalanx of the right hallux (Figure 1A). Hospital Course: Patient had a significant infection and was admitted to the hospital and placed on intravenous (IV) antibiotics. The patient was taken to the OR for initial incision and drainage (debridement). The post-debridement culture results were few Staphylococcus aureus. A filet of hallux was performed, which involved removing the proximal and distal phalanx with preservation of the overlying soft tissue envelope. V.A.C. VeraFlo Therapy was initiated using V.A.C. VeraFlo Dressing. Prontosan (B. Braun Medical Inc., Bethlehem, PA) was instilled until the foam was filled, followed by a soak time of 10 minutes. Instillation was repeated every 3.5 hours, followed by continuous negative pressure at -125 mmhg for 4 days (Figures 1B-1D). The patient was then taken back to the OR for a second debridement (Figure 1E). The predebridement culture results from this OR visit were no growth. The portion of the soft tissue envelope was used for closure. Discharge and Follow-up: Patient was discharged home with prophylactic antibiotics and subsequently followed up at clinic. Clinical Outcome/ Conclusions: No incision dehiscence or wound complications were noted on subsequent visits. Figure 1A. Osteomyelitis of proximal and distal phalanx of the right hallux Figure 1B. Application of V.A.C. VeraFlo Dressing Figure 1C. Application of V.A.C. Advanced Drape Figure 1D. Application of V.A.C. VeraFlo Therapy Figure 1E. Second debridement

4 Clinical Case 2 Patient was a 47-year-old male with a history of Type II DM, peripheral neuropathy, and a healed transmetatarsal amputation. Diagnosis: Patient presented with cellulitis, abscess, and a chronic wound on the sub 5 th metatarsal with exposed bone (Figure 2A). Hospital Course: Patient was admitted to the hospital and placed on IV antibiotics. The patient was taken to the OR for initial incision and drainage (debridement). The post-debridement culture results were rare Pseudomonas aeruginosa. V.A.C. VeraFlo Therapy was initiated using V.A.C. VeraFlo Dressing. Prontosan was instilled until the foam was filled, followed by a soak time of 10 minutes. Instillation was repeated every 3.5 hours, followed by continuous negative pressure at 125 mmhg for 2 days (Figures 2B and 2C). The patient was then taken back to the OR for a second debridement (Figure 2D). The predebridement culture results from the second OR visit were no growth. The wound was then subsequently closed. Discharge and Follow-up: Patient was discharged home with prophylactic antibiotics and subsequently followed up in clinic. Clinical Outcome/ Conclusions: No incision dehiscence or wound complications were noted on subsequent visits. Figure 2A. Abscess on plantar of right foot Figure 2B. Application of V.A.C. VeraFlo Dressing Figure 2C. Application of V.A.C. VeraFlo Therapy Figure 2D. Second debridement V.A.C.Ulta Therapy System: Collection of Case Studies

5 Clinical Case 3 Patient was a 66-year-old male with a history of alcohol-induced peripheral neuropathy and an ulcer of 1 year duration. Diagnosis: Patient presented with cellulitis, abscess, osteomyelitis, and a chronic ulcer on the lateral 5 th metatarsal base secondary to cavo-varus foot type (Figure 3A). Hospital Course: Patient presented to the clinic with cellulitis/abscess on the lateral aspect of his right foot. Patient was admitted to the hospital and was placed on IV antibiotics. The patient was taken to the OR for initial incision and drainage (debridement) (Figure 3B). The post-debridement cultures results were few Coagulase Negative Staphlyococcus, rare Pseudomonas aeruginosa, and rare cornebacterium. V.A.C. VeraFlo Therapy was initiated using V.A.C. VeraFlo Dressing. Prontosan was instilled until the foam was filled, followed by a soak time of 10 minutes. Instillation was repeated every 3.5 hours, followed by continuous negative pressure at -125 mmhg for 3 days (Figure 3C and 3D). The patient was then returned to the OR for a second debridement. The predebridement culture results from the second OR visit were no growth. The wound was closed with antibiotic spacer (ie, cement impregnated with vancomycin and gentamicin) (Figure 3E). Discharge and Follow-up: Patient was discharged home with prophylactic antibiotics and subsequently followed up in clinic. Clinical Outcome/ Conclusions: No incision dehiscence or wound complications were noted on subsequent visits. Figure 3A. Cellulitis/abscess on the lateral aspect of right foot Figure 3B. Debrided wound Figure 3C. Application of V.A.C. VeraFlo Dressing and V.A.C. Advanced Drape Figure 3D. Application of V.A.C. VeraFlo Therapy Figure 3E. Wound closed with antibiotic spacer

6 Impact The necessity to eradicate infection prior to closure or coverage is a fundamental tenet for the management of an infected wound. Whether a wound is infected is largely determined through clinical assessment (nonspecific and lacking consensus) and deep tissue cultures (have limitations, but are more objective). The physicians relied on postdebridement culture results obtained prior to the surgery to assess the appropriateness for closure or coverage at the time of the subsequent surgery. The physicians noted a significant positive change in wound quality based on clinical assessment after V.A.C. VeraFlo Therapy with Prontosan instillation in all 3 cases presented here. The physicians observed that using V.A.C. VeraFlo Therapy after initial debridement resulted in a decrease or elimination of bacteria in the wound at the time of subsequent operation. Hence, the wound could be covered or closed sooner. This early coverage may result in a decrease in the number of surgeries performed, which reduces both the number of times the patient undergoes anesthesia and the likelihood of complications associated with anesthesia. Furthermore, a potentially shorter hospital stay with early coverage or closure may translate to a decrease in the number of inpatient complications (eg, hospital-acquired pneumonia or hospitalacquired multi-resistant bacteria). These outcomes may directly reduce financial burden for the treatment of infected wounds. Initial findings have provided a glimpse into supporting the hypothesis that V.A.C. VeraFlo Therapy may have a direct and important impact on the clinical and surgical approach to the infected wound. V.A.C.Ulta Therapy System: Collection of Case Studies

7

8 V.A.C.Ulta and V.A.C. VeraFlo Therapy Components Solution Container Hanger Arm Canister V.A.C. VeraFlo Dressing Kit V.A.C. VeraFlo Cleanse Dressing Kit Instillation Cassette (V.A.C. VeraLink Cassette) V.A.C.ULTA SYSTEM ORDERING INFORMATION Part Number Description ULTDEV01/US V.A.C.Ulta Therapy Unit, United States ULTVFL05SM V.A.C. VeraFlo Dressing, 5-pack, Small ULTVFL05MD V.A.C. VeraFlo Dressing, 5-pack, Medium ULTVCL05MD V.A.C. VeraFlo Cleanse Dressing, 5-pack, Medium ULTLNK0500 V.A.C. VeraLink Cassette, 5-pack Prontosan Wound Irrigation Solution with Adapter, case of 10 ULTDUO0500 V.A.C. VeraT.R.A.C. Duo Tube Set, 5-pack M /5 500 ml InfoV.A.C. Canister with Gel M /5 1,000 ml InfoV.A.C. Large Canister with Gel *V.A.C.Ulta Therapy Unit is compatible with all the InfoV.A.C. Canisters For more information about the V.A.C.Ulta Therapy System, contact your KCI Representative , or visit NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for KCI products and therapies. Please consult a physician and product instructions for use prior to application. Rx only 2012 KCI Licensing, Inc. All rights reserved. Prontosan is a trademark of B.Braun Medical, Inc. All other trademarks designated herein are proprietary to KCI Licensing, Inc., its affiliates and/or licensors. DSL# US Lit#29-D-303 (REV. 9/14)

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