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Lecture Hall Wound Care | Treatment

Vacuum Assisted Closure in Optimizing the Wound


Lawrence Lavery
Lawrence Lavery, DPM, MPH
Professor and Director of Clinical Research
Department of Plastic Surgery
University of Texas - Dallas, TX
System Requirements Method of Participation Disclosure Information
Lecture Transcription
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Present e-learning systems

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My name is Lawrence Lavery. The title of this presentation is Vacuum Assisted Closure in Optimizing the Wound.

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Production of this PRESENT Lecture was made possible by a generous grant from KCI.

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The VAC Therapy system is intended to create an environment that promote wound healing by secondary or tertiary intention by preparing that wound for closure. The VAC system fulfills many of the objectives of an ideal wound care product. It helps maintain a moist wound environment. It removes infectious materials. It reduces edema. It ensures that there is adequate local blood supply to promote adequate granulation tissue formation.

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Because of the unique design of the wound sponge and the application of negative pressure in the VAC system, The VAC creates cellular microdeformation which applies a localized negative pressure to help uniformly draw the wound closed. The VAC system provides a closed, moist wound healing environment and it helps promote the survival of flaps and grafts.

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There are a number of indications for VAC therapy. It can be used in both chronic and acute wounds, wounds of traumatic ideology, partial thickness burns, dehisced surgical wounds, diabetic foot ulcers, pressure ulcers, flaps as well as grafts.

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There are a number of relative contraindications to using VAC Therapy. The following dressing sponge should not be applied in direct contact with exposed blood vessels, organs or nerves. The VAC should not be used when there is suspicion of malignancy in the wound, when patient has untreated osteomyelitis, when there’s unexplored fistulas, when there’s necrotic tissue with eschar present in the wound, and in patients that have sensitivity to silver.

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For the rest of my talk, I’m going to focus on clinical outcome. I want to take a few minutes to look at the basic signs that help explain a bit about why the VAC is so effective. I’m going to address 4 studies that give us some indication of how the VAC affects the wound environment in a cellular level.

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These studies will demonstrate that VAC therapy increases microvessel density in the wound bed, that it increases local perfusion, promotes granulation tissue formation, and reduces the activity of selected Matrix metalloproteinase’s in the wound.

~10

This is one of the classic studies that demonstrate the effectiveness of VAC therapy to increase local perfusion. This was done by inventors of the wound VAC at Lake Forest. The study used a peak model to evaluate the effect of the VAC on perfusion and granulation tissue formation. They used a laser Doppler in this study to evaluate perfusion at the wound bed. But authors created a 2.5 centimeter diameter wound down to fascia on 20 kg Chester Peaks. A laser Doppler needle probe was then inserted into the subcutaneous tissue and muscle to measure perfusion as they increased pressure with the VAC in 25mmHg increments up to 400mmHg. The continuous laser Doppler data was recorded using both continuous and incremented pressures. Peak flow, that’s 4 times the baseline values used are recorded at 125mmHg as demonstrated on the left hand portion of the graph. Laser Doppler values depressed below baseline had pressure of 400mmHg or higher as demonstrated in the right hand portion of the graph.

~11

In the same article, the authors evaluated granulation tissue by creating identical wounds on the back of pigs; they measured the volume of the wound everyday with algenate impressions. Wounds were treated with pressure wound therapy or normal saline dressings. The authors evaluated wounds with 125mmHg continuous sub-atmosphere pressure, wounds at 125mmHg with intermittent sub-atmosphere pressure and control wounds treated with normal saline. The results of the study shows that wounds treated with such atmosphere pressure filled with granulation tissue significantly faster than the control wounds. The mean increase in granulation tissue compared to the control was 63% with continuous negative pressure wound therapy and 103% increase in intermittent therapy.

~12

Teams and co-workers studied skin perfusion with 2 types of foam used with negative pressure wound therapy. They studied black polyurethane and white poly-vinyl alcohol foam. They looked at continuous blood flow measured with non-invasive laser Doppler probes on the forearm of each subjects. Comparisons with the cutaneous blood flow to baseline showed a significant increase up to 300mmHg. Using the black polyurethane foam, there was a 5-fold increase in local skin perfusion compared to baseline. Using the white foam, there was a 3-fold increase in perfusion. In this study, there was no reduction perfusion noted with negative pressure wound therapy.

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Green and colleagues evaluated the effect of negative pressure wound therapy to improve angiogenesis and matrix metalloproteinase activity and chronic wounds. They studied three debilitated patients with chronic wounds. They evaluated tissue debrided from the area with and without VAC contact to assess microvessel density and amino histo-chemistry to assess key levels. Areas with VAC contact demonstrated greater microvessel density compared to the same area prior to therapy. In the graph, you can observe the significant changes that are observed with granular foam at week 1 and week 2.

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Green also demonstrated a significant reduction in MMP-2 and MMP-9 activity at weeks 1 and 2 at areas that were in contact with the foam. This is demonstrated in the graph

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In a study from China, She-an colleagues evaluated changes in MMP related to negative pressure wound therapy as well. They studied the impression of MMP 1, 2, and 13 from granulation tissue at 1, 4 and 7 days after therapy and 5 patients had chronic wounds. There were significant reductions in mRNA of all three MMP’s studied at day 4 and day 7. The greatest reduction was noticed in MMP-13 followed by MMP-1.

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Wound healing is a complex process. In the clinical setting there are varieties of therapies that we use as part of the spectrum of care. We tend to change therapies as the wound changes. One of the questions about advanced therapies is when they should be implemented. I’m going to discuss events in clinical study that may help us identify patients that are more likely not to respond to standard therapies and therefore help us target patients for advanced therapies like the wound VAC earlier in the course of therapy. Certainly not use of the VAC has changed over the last 10 years. In the past, I primarily used VAC in patients with history of poor healing or prolonged healing. I used to offer this in patients who had failed other therapies first. As a matter of fact, as part of one of the early practice guidelines for the wound VAC, we recommended that it be used after standard therapy failed. We think that evidence now supports more aggressive and earlier use of the VAC. I think we also intended to use this more frequently on patients that have had deep wounds with exposed tendular bones or patients that have large areas of tissue loss after surgical debridement. Now I am more likely to use the VAC as first line therapy much earlier in the course of therapy and in smaller wounds when they have initially failed to respond to therapy.

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One of the Piblow questions is if it is better to initiate an advance therapy such as the wound VAC early or late in the course of therapy. VAC is often used as a salvage procedure. If we can initiate interventions in high risk patients early therapy may be more effective. We may be able to reduce the cost of therapy and we may be able to prevent more re-amputations in patients. In 2008, we published a paper in Diabetes Care that was part of a post-hoc analysis from the open amputation fact right __________ study that was published in Lancet in 2005. We really tried to identify opportunities to predict wounds that were going to fail. We do the logistic regression and evaluated patients that healed or patients that did not heal during the 16 week evaluation period. Our primary outcome measure was that the present wound reduction area compared to baseline, we looked at assessments that are at 1 week and 4 week time periods. And we primarily wanted to see so we could identify change in wound area early in the course of therapy that would predict patients that would eventually heal and patients that would fail to heal in the whole 16-week evaluation period.

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This is a graph that demonstrates the percent wound area reduction at 1 week and 4 weeks. We chose a target of at least a 15% change in wound area compared to baseline for the 1-week target and 60% reduction in wound area for the 4-week target. The graph shows the proportional wounds that run in 4 weeks and then achieve the percent change in wound area of 15% and 60%. At one week, if patient’s had at least 15% wound area reduction, 68% of patients healed compared to 32% of subjects that failed to meet that target. Likewise, at 4 weeks, if the patient had a percent wound area reduction compared to baseline of at least 60%, 77% of those patients healed. If they failed to meet that target, only 30% of those patients eventually healed during the 16-week evaluation period.

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These graphs look at percent in wound area reduction at 1 and 4 weeks in patients that received VAC therapy compared to control groups that received moist wound therapy. At 1 week and at 4 weeks, patients that received VAC therapy were more than two times as likely to reach the percent wound area reduction target as the control group. I think this data provides us with important insights that I think many of us have identified from our own comical intuition that we can identify that wounds early in a disease process and the treatment process that don’t appear to be progressing and in many instances, very early in the treatment course, as early as one week, again identified in this data, we can identify patients who are likely to fail therapy at 16-weeks.

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This graph shows the wound healing trajectories. At 1 week, with VAC therapy and standard wound care. Most wound therapy treated patients, had to achieve a 37.5% wound area reduction and had one week to achieve a 50% probability of healing. VAC therapy treated patients had to achieve a 7% wound area reduction after 1 week to achieve a 50% probability of healing during the 16 weeks evaluation period.

As you can see from the slope of the graphs, the VAC has shifted the wound trajectory significantly compared to the trajectory of patients that received moist wound therapy.

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This is a similar graph that shows trajectories at 4 weeks. Again, patients that were treated with moist wound therapy had to achieve a 68% wound area reduction at 4 weeks for a 50% probability of healing. While VAC therapy patients had to achieve a 45% wound area reduction for the same 50% probability of healing. Again, you can see that the blue line representing patients treated with VAC therapy shifted significantly compared with patients with moist wound therapy.

~22

Next, I want to spend a few minutes to talk about the two large grand muscular trials that have been performed to evaluate the effectiveness of VAC therapy in the Diabetic foot. The first study was in open amputation wounds and published in the Lancet in 2005. The second study evaluates the way diabetic ulcers and was published in diabetes care in 2007

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David Armstrong and I were fortunate to be able to collaborate on this project and participate in the analysis and preparation of the paper that was publish in the Lancet 2005, titled “Negative Pressure Wound Therapy after partial diabetic foot amputations multicentre randomized controlled trial”. This was a single blinded randomized clinical trial with a 16-week evaluation period. A hundred and sixty-two patients were enrolled at 18 centers in the United States. There were two treatment arms for this study. Patients were either randomized to receive negative pressure wound therapy or they received standard wound care based on WOCN guidelines. This was a post marketing study and so we had some discretion in the standard of wound therapy. Generally, phase 3 studies use saline solution, gauze, as the control group based on the proponents of the DFA.

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The study population in this clinical trial were patients with diabetes that had forefoot amputation wounds. And these had to be at the level of trans-metatarsal amputation or distal amputations. The 162 patients were randomized; 77 were randomized to receive VAC therapy and 85 were randomized to receive moist wound therapy based on the guidelines as I previously stated. The primary endpoint was evaluating the proportion to the patients of each group that had complete wound closure defined as complete epithelialization of the wound without drainage. The secondary endpoints were foot salvage or prevention of additional amputations and treatment related adverse events or complications.

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Assessment of wounds and the period of assessment was pretty standard as demonstrated in the first sentence of the slide. Patients were evaluated at baseline at 7, 14, 28, 42, 56, 84, and 112 days. The wounds were documented with digital photographs and by later acetate tracings to access the wound area. Decisions were asked to estimate the proportion of the wound that was covered in granulation tissue. The photographs were subsequently evaluated by a blinded reviewer. The area of the wound was also assessed by this blinded view as well.

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This is a table with wound and patient characteristics. The wounds in this study were large there were of 78 times larger than most randomized clinical studies that had been previously being conducted with diabetic foot ulcers. These wounds had been present for more than a month so an average of the VAC wasn’t use immediately after the amputation was performed. And all of the patients in the study had good perfusion as measured by endobrachial in disease and transcutaneous oximetry . The mean ABI in both treatment groups was 1.1 in TcPO2s were greater than 40 mm Hg in average. And as expected the vast majority of patient in both treatment arms had central myopathy.

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This graft shows the Kaplan-Meier survival analysis for patients treated with VAC and moist wound therapy. There’s a significant difference in the survival analysis in patients that received VAC therapy. The median time in the study for VAC patients was 59 days compared to a 106 days for patients in the control group. In addition there were significantly more patients in the VAC group that healed compared to the control group. 56% of VAC patient healed during the 16 week evaluation period compared to 39% of patients that received moist wound therapy.

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This graft compares the change in granulation tissue in patients that received VAC therapy and moist wound therapy. There was a significant increase in the proportion of wounds that had 75 to 100% granulation tissue in the VAC group. In addition the median time to reach this level was 42 days in VAC patients compared to 84 days in the control treatment arm.

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One of the secondary objectives of the study was limb solage. This graft compares patient that required a second amputation during the 16 week follow-up period. There was strong trend although it wasn’t statistically significant in this study demonstrating fewer additional amputations for patients treated with VAC therapy. In the VAC group there were 2 additional amputations with no proximal amputations. In the control group there were 9 additional amputations, 3 were below knee amputations and 2 were above knee amputations.

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Another secondary objective of the study was to evaluate the frequency of adverse events in VAC patients and control patients. In this study there were no differences in the frequency of adverse events in the two treatment arms. For adverse events that were not related to infections there were 9 of these in the VAC treatment group, one was noted to be serious. In the control group there were 11 adverse events that were not related to infection, 5 were noted to be serious. The same was true for adverse events related to infection. There were 13 infections identified in the VAC therapy group. There were no serious infections and no treatment related infections. In the control group 5 infections were identified as adverse events, 2 were treatment related and one was noted to be serious.

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This study is important for couple of reasons. It is the first prospective study of open amputation and patients with diabetes and it is the first large multicenter randomized clinical trial using VAC therapy in the treatment of open amputation and persons with diabetes. There was also the study suggest that treatment with negative pressure wound therapy utilizing the VAC delivery system heals a higher proportion of wounds than standard therapy. It shows that there is rapid and very robust granulation tissue response in patients that received VAC therapy controls and showed a very strong trend towards a reduction in the risk of amputation compared to a control group.

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In this study the population that we evaluated constituted wounds that were much larger and more complex than previous randomized clinical trials that had been evaluated diabetic foot ulcers. Previous diabetic foot ulcer studies primarily included Wagner grade 1 ulcers that were less severe and more superficial wounds than the open amputation wounds that were the objective of this study. An average the wounds in this study were 7 to 8 times larger than the wounds evaluated in diabetic foot ulcer studies. The other diabetic foot ulcer studies were less severe and more superficial wounds but ended up having the same closure rate of about 50% as we experienced in this clinical trial.

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Another interesting outcome of this project was the high rate of healing that was observed in the control group. 39% of the wounds healed in the control arm of the study compared to about 20% in other randomized clinical study of diabetic foot ulcers. This may be related to the ability of the commission to change the wound regimen based on W.O.C.N. guidelines rather than having to use a controlled dressing with normal saline. It may also be related to the opportunity we had in the study to use a more sophisticated and effective offloading regimen. In this clinical trial we were able to use removal cast boots in other clinical studies of the Grandex and Apple graft for instance they use custom healing sandals or therapeutic shoes and in soles which has been demonstrated in bench top studies in the gate lab to be much less effective at reducing pit pressures at the side of foot ulcer and they have been demonstrated in other randomized clinical studies to be much less effective at healing foot ulcers.

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The next study that I want to discuss was published by Peter Bloom and co-workers that published diabetic care in 2007.

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Liked the previous study this was a single blinded randomized clinical study. The objective of this study was to evaluate the safety and efficacy of negative pressure wound therapy compared to advanced moist wound therapy for the treatment of diabetic foot ulcers. The VAC was used as modality to provide negative pressure wound therapy and the treatment arm.

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The subjects included in this study were stage 2 or 3 foot ulcers including wounds, arm, the heel, dorsal and plantar of the foot. 342 patients were randomized to participate in the study. 169 patients were randomized to receive VAC therapy and 66 patients to receive the moist wound therapy. There were 29 locations that participated in the study, 28 in the United States and 1 in Canada. As in the previous study the primary end point was the instance of complete wound closure. Secondary end point were reduction in ulcer surface area, time to achieve ulcer closure and reduction in complications including reducing additional foot and leg amputation.

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The VAC in this study was applied for the first 4 weeks everyday and then every other week until Day 112 or until the ulcer closed. VAC therapy was provided in both an acute care setting and in the home setting. Wounds were assessed in the same way as they were in the previous study and positions evaluated granulation tissue changes as previously described as well. VAC was changed every 48-72 hours per manufacturer’s recommendations. Patients that received moist wound therapy were treated again based on WOCN guidelines.

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The subjects included in this study were stage 2 or 3 foot ulcers including wounds, arm, the heel, dorsal and plantar of the foot. 342 patients were randomized to participate in the study. 169 patients were randomized to receive VAC therapy and 66 patients to receive the moist wound therapy. There were 29 locations that participated in the study, 28 in the United States and 1 in Canada. As in the previous study the primary end point was the instance of complete wound closure. Secondary end point were reduction in ulcer surface area, time to achieve ulcer closure and reduction in complications including reducing additional foot and leg amputation.

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In additional there’s a higher proportion of subjects that reached the 75% closure mile stone in the VAC group. 62% of VAC patients reached this target compared to 51% in the control arm. The median time the 75% wound closure was 56 days in the VAC group compared to 114 days in the control group. There was also a higher proportion of subjects whose wounds had 75 to 100% granulation tissue formation in the VAC group compared to patients in the moist wound therapy group.

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Like the first VAC study that we discussed, this study is distinct for a number of reasons. For patients on VAC therapy complete ulcer closure was significantly more likely than patients that received moist wound therapy. 43% of VAC patients had complete wound closure compared to 29% of patients in the control group. There was a 60% reduction in relative risks of a second amputation for VAC patient compared to control subjects.

~41



In addition there was a significant difference in granulation tissue response in patients that received VAC therapy. The time to achieve 76-100% closure was 2 times longer for patients in the control group compared to patients that received the VAC. In these studies support the previous randomized clinical studies in open amputations.



~42



The next few slides addressed the cost comparison of VAC wound therapy and moist wound therapy. This analysis is based on data from a land set open amputation randomized clinical trial those published in 2008. This paper was published in American Journal Surgery in 2008 and the first author was John Apelquist. We’ll look at a different number of cause elements in this paper. This table shows the average treatment cause for patients that completed at least 50% of the study. A couple of areas that show large differences in treatment groups, I think exemplify the savings that are realized using the VAC therapy. The first is antibiotics the cause for antibiotics in the VAC group was $9,096 compared to $24,845 in the control group. The next large difference is in the bulk and cost of hospitalization. The cost for hospitalization of the VAC group $38,794 compared to $46,617 and the third group, the large difference is the cost of dressing materials and the personnel for dressing changes. From the VAC groups these cost were thick $6,022 and $1,244 compared to $7, 321 and $3,395 in the moist wound therapy group. The overall average cost for VAC patients was $27,270 compared to $36,096 in the moist wound therapy group.



~43



This table shows the average treatment cost comparing VAC and moist wound therapy. When we analyze this data we look at several difference scenarios. This table shows the cost for patients that healed, for patients that completed at least 8 weeks of therapy and for all patients that participated in the randomized clinical trial. No matter how we stratified the cost groups there was a significant reduction in the cost of therapy in patients that were treated with the VAC. The cost difference in VAC therapy ranged from $8,206 in patients that were treated at least for 8 weeks to $12, 800 for patients that achieved complete wound closure.



~44



The results of the economic study suggested when VAC therapy was compared to moist wound therapy from the clinical trial of open amputations. The average lower direct treatment cost was achieved of $8,826. The average lower direct treatment cost for patients who reached healing was $12,852. VAC therapy was more effective in wound healing and also much less costly an average than patients that received moist wound therapy based on W.O.C.N. guidelines. VAC therapy is a cost-effective intervention for post-operative diabetic foot ulcer patients. This needs to be part of our message to healthcare administrators who were trying to make financial decisions in the absence often of good financial information.



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I liked to finish this presentation with a case presentation that exemplifies the positive outcomes received with VAC therapy. This is a 56 year old gentleman with severe sensorial neuropathy who presented to the emergency department with a 3 day history of fever and chills and a 4 week history of foot ulceration. He had refused to use a removal fracture boot or a total contact cast because he didn’t find them comfortable. He presented to the emergency department with the abscess that extended along his flexor tendons and considerable cellulites and was feeling very ill.



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The patient was subsequently admitted to the hospital and taken to the operating room where incision and drainage was performed. The ulcer extended to his flexor tendon and there was an abscess along the tendon sheath. In addition the tibular and tibial sesamoid bones were noted to be soft and discolored. A portion of this flexor hallucis brevis tendon as well as sesamoid bone subsequently excised period. Deep cultures were taken and the VAC was initiated the next day.



~47



We were able to use a bridging technique to apply the sponge to the sole of the foot and bridge to the dorsum of the foot. We’re then able to immobilize him in a removal fracture boot.



~48



This is an example of a patient who has the hose of his VAC extending to the front of his removal cast boot. The graft on the left of this slide shows data from a study that was conducted by Dave Armstrong. The study compares pit foot pressures in removal cast boots with and without the VAC applied to the foot. This study shows there’s no difference in pressure attributed to using the wound VAC on the sole of the foot.



~49



These were photos of the wound 3 days and 6 days post-debridement. As you can see on slide on the left there’s only a small portion of the tendon that is still visible at the distal portion of the wound. By day 6, all of the flexor tendon is covered with granulation tissue.



~50



These are photos from 14 days and 21 days after debridement. As you can see the wound is almost completely covered with granulation tissue there’s no detracting and by day 21 the bone is beginning to contract.



~51

These are additional photographs of this patient at post 5 days

~52

In conclusion, there’s a growing body of evidence to suggest that we can identify patient’s early in their course of therapy. To identify patients who are likely not to heal using traditional wound therapy, as opposed to waiting until they have failed for 4 or 8 weeks. Both arms of clinical studies in the diabetic foot has shown that this therapy promotes granulation tissue to expose on the deep structures that contributes to a higher proportion of healed wounds. It is a fact that limb salvage and that here are fewer amputations, and as a result of VAC therapy. And finally as an added benefit, there is significant cost savings when VAC therapy is employed for complicated patients.

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Production of this PRESENT lecture was made possible by a generous grant from KCI.

This presentation discusses the role of negative pressure wound therapy in the
treatment of diabetic foot uclers and open amputation wounds. In adition we will discuss
the the use of wound trajectories at 1 and 4 weeks of treatment to predict final wound healing.
And we will discuss the cost of NPWT and mosit wound therapy.
Goals and Objectives
After participating in this activity, the viewer should be better able to:

1. To discuss the mechanism of action of negative pressure wound therapy
2. To discuss the clinical evidence for NPWT for diabetic foot ulcers and open amputation wounds
3. To discuss the economic benefit of NPWT
4. To discuss the change in wound trajectories in NPWT and standard moist wound therapy

Estimated time to complete this activity is 50 minutes.
Target Audience
Physicians, diabetes educators, and other health care professionals who treat patients with diabetes.
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Vacuum Assisted Closure in Optimizing the Wound
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Vacuum Assisted Closure in Optimizing the Wound
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  • Complete and submit the required pre-test
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Disclosure Information
Vacuum Assisted Closure in Optimizing the Wound
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It is the policy of PRESENT e-Learning Systems and it's accreditors to insure balance, independence, objectivity and scientific rigor in all individually sponsored or jointly sponsored educational programs. All faculty participating in any PRESENT e-Learning Systems programs are expected to disclose to the program audience any real or apparent conflict(s) of interest that may have a direct bearing on the subject matter of the continuing education program. This pertains to relationships with pharmaceutical companies, biomedical device manufacturers, or other corporations whose products or services are related to the subject matter of the presentation topic. The intent of this policy is not to prevent a speaker with a potential conflict of interest from making a presentation. It is merely intended that any potential conflict should be identified openly so that the listeners may form their own judgments about the presentation with the full disclosure of the facts.
Lawrence Lavery, DPM, MPH has nothing to disclose.
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Although cookies do not normally contain personally identifiable information, if you are a registered user, we may elect to associate your registration information with cookies our Web site places on your computer's hard drive. Associating a cookie with your registration data allows us to offer increased personalization and functionality. For example, you can elect to have our Web sites "remember" your user name and password and bypass the sign-in process on each visit to the site. Without cookies, this functionality would not be possible. Some of our business partners may use cookies on our site (for example, advertisers.) We have told them that we do not want them to use cookie information to track our users' activities once they leave our Web sites. However, because of the way advertisements are served on our Web sites, we do not have total control over how advertisers use cookies on our Web site. If you believe that one of our advertisers is placing an unwanted cookie on your hard drive, please contact privacy officer ( privacy@presentdiabetes.com ) to assist us in resolving the problem.

Uses We Make of Information

In this section of our Privacy Policy, we identify the ways we may use information about you that we have collected.

Aggregate Data

We collect data about visitors to our Web sites for product development and improvement activities. We also use it for market analysis. We may provide information from our Web sites in aggregate form, with identifying information removed, to third parties. For example, we may tell a health care partner what percentage of our registered users are of a particular medical specialty or have certain credentials. Any third party that receives our data must agree not to attempt to re-identify the people it belongs to. For example, we may provide information to a potential advertiser of a product that would appeal to a diabetes patient about what percentage of our users have diabetes. Depending on our agreement with the third parties, we may or may not charge for this information.

Marketing and Advertising

We may target our advertising or marketing depending on information we have about you. For example, a user that is a healthcare professional who treats diabetes may receive advertising for new diabetes therapies (although in neither case will the advertiser have access to any individually identifiable information about you). We may also personalize our Web site based on your interests. For example, you may see different articles in different places on our Web site based on information you have shared with us, or information we have gained by observing your previous behavior, or information we may have gained from your interactions with a third party that shares information with us. We use information for our own internal marketing, research, and related purposes. Third Parties In addition to aggregate information (discussed previously), we may share some kinds of personally identifiable information with third parties as described below.

Other Companies: We have strategic relationships with other companies who offer products and services on our Web sites. When you are interacting with those companies, different rules and privacy policies may apply. We do not control the collection or use of information you provide to these companies, but we do require that those companies clearly state their policies so you can decide whether to give them any information.

Our Employees and Consultants: We contract with other companies and individuals to help us provide services. For example, we may host some of our Web sites on another company's computers, hire technical consultants to maintain our Web-based tools, or work with companies to remove repetitive information from customer lists, analyze data, provide marketing assistance, and provide customer service. In addition, if you are a healthcare professional, we may validate your licensure status and other information against available databases that list licensed health care professionals. In order to perform their jobs, these other companies may have limited access to some of the personal information we maintain about our users. We require all such companies to comply with the terms of our Privacy Policy, to limit their access to any personal information to the minimum necessary to perform their obligations, and not to use the information they may access for purposes other than fulfilling their responsibilities to us. We use our best efforts to limit the use of other companies in areas where personally identifiable information may be involved.

Promotional Offers: Sometimes we send offers to selected groups of customers on behalf of other businesses. When we do this, we do not give that business your name and address. We provide a variety of mechanisms for you to tell us you do not want to receive such promotional offers. For example, we may provide an opt-in box for consumers to receive an email from another business, and we make clear that by opting in you are submitting your data to a third party.

Protection of Information

In this section of our Privacy Policy, we discuss the security measures we take to protect information that we have collected about you.

We have implemented technology and security policies, rules and other measures to protect the personal data that we have under our control from unauthorized access, improper use, alteration, unlawful or accidental destruction, and accidental loss. We also protect your information by requiring that all our employees and others who have access to or are associated with the processing of your data respect your confidentiality. We use security methods to determine the identity of its registered users, so that appropriate rights and restrictions can be enforced for that user. Reliable verification of user identity is called authentication. We use both passwords and usernames, as well as double opt-n verification, to authenticate users. Users are responsible for maintaining their own passwords.

Access to Information and Choices

In this section of our Privacy Policy, we tell you how to obtain and correct information we have about you, and how to choose what types of information you may share with us.

Correction of Information We Have About You

If you believe that registration information collected by our Web site(s) is in error, you may edit your personal profile any time that you like. You can directly edit most of your user profile on the Web site on which you initially registered. Information that you can not edit may only be changed by contacting Web Customer Support (see CONTACTS). Requests for deletion of your record may result in your removal from the registry, but we may keep certain demographic information about you for product improvement purposes. You may contact Web Customer Support and ask for the changes that you would like to make.

Our Employees

Our employees are required to keep customer information private, as a condition of their employment with the company. Only selected, authorized employees are permitted to access personal information. Our employees with access to personally identifiable information are required to attend a confidentiality/privacy training class, and to sign a confidentiality agreement. All employees and contractors must abide by our Privacy Policy, and those who violate that policy are subject to disciplinary action, up to and including termination of their employment and legal action.
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