Determining Properties of Wound Dressings for Negative

Pressure Wound Therapy

Donor Organization: Federal Government Agency

Recipient Organization: Pioneer Technology

Lora Aboulmouna, Ryan Frye, Lisa Lewicki

Undergraduate Students at Vanderbilt University

(615) 421-6014

Table of Contents

Abstract 3

Introduction 3

History and Context 4

Team 6

Work Plan and Outcomes 7

Evaluation and Sustainability Plan 8

References 8

Appendix 8Gantt Charts 9-13Budget Template 14Budget Justification 15Resumes 16-18

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1. Abstract

Foam and gauze are currently the two most commonly used wound fillers for negative pressure wound therapy (NPWT). Pioneer Technology, located in Nashville, Tennessee, has obtained the exclusive rights to a proprietary wound dressing known as Sorbact. Sorbact is a hydrophobic, wide meshed, material which we believe is the ideal candidate for a NPWT dressing interface. Because Sorbact is hydrophobic, it is our belief that the fluid dynamics under NPWT will closely resemble that of the foam dressings available by KCI. In all likelihood, we expect to learn that the effective flow of fluids through Sorbact will fall somewhere between both foam and gauze, however it is necessary to substantiate this.

The primary objectives our study will focus on are:

to create a model which tests and compares the fluid dynamics of all three dressing interfaces (cotton gauze, KCI foam, and Sorbact) subjected to various environments

noting the difference in rigidity between foam, gauze and Sorbact to investigate the necessary pressure needed to achieve optimal macro-strain and micro-

strain

Negative Pressure Would Therapy is something which has been around for 100s of years, but has only been commercialized in the last twenty years. The market for the dressing interface that is used in conjunction with NPWT is a billion dollar market. Obtaining a large share of the market can be obtained by proving that the Sorbact is a competing product due to its fluid dynamics and additional benefits. The educational outcomes that are hoped to be achieved include uncovering a better material for covering wounds that allows for quicker healing with a reduced chance of infection.

2. Introduction

Foam and gauze are the two most commonly used wound fillers for negative pressure wound therapy (NPWT). NPWT is the application of sub-atmospheric pressure to a sealed wound for the purpose of removing fluid and stimulating a cellular response through the mechanical stretching of wound tissue. This stretching is known as macrodeformation — contracting of the wound site — and micro-deformation — cellular stretching. The choice of wound filler influences the biological effects of the therapy. In several clinical studies, when using foam, thick but fragile granulation tissue formed after NPWT was applied. The granulation tissue formed after NPWT using gauze was thinner and denser. Also, foam tends to stick to the wound and, upon removal, the patient may experience pain, disrupting some of the tissue in the wound bed. NPWT may result in macrodeformation, contraction of the wound. Studies have shown different pressure ranges affect biological processes on the wound edge, including blood flow and macrodeformation. A pressure of -80 mm Hg has maximal effects on wound pressure therapy (Borgquist et al).

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NPWT was only commercialized in the last twenty years, although it has been around for centuries. Kinetic Concepts Inc. (KCI) located in San Antonio, Texas, successfully commercialized NPWT, renaming it VAC (Vacuum Assisted Closure) Therapy. Today this market represents 1.5 Billion, 95% of which is dominated by KCI due to extensive intellectual property claims.

Of this intellectual property (IP) the most significant rests upon the KCI proprietary Foam Dressing Interface. The foam is constructed from polyurethane, and offers a reticulated hydrophobic structure allowing for both macro-strain and micro-strain resulting in the uniform disbursement of pressure through the dressing material.

Today competitors are limited to using standard cotton gauze as the NPWT dressing interface. Cotton of course if hydrophilic (Ljungh et al, 2006). When the gauze becomes saturated, the internal pathways occlude preventing the delivery of fluid and pressure through the dressing interface, and therefore preventing micro-strain.

Pioneer has obtained the exclusive rights to a proprietary wound dressing known as Sorbact. Sorbact is a hydrophobic, wide meshed, material, which we believe is the ideal candidate for a NPWT dressing interface. Because Sorbact is hydrophobic, it is our belief that the fluid dynamics under NPWT will closely resemble that of the foam dressings available by KCI. In all likelihood, we expect to learn that the effective flow of fluids through Sorbact will fall somewhere between both foam and gauze, however it is necessary to substantiate this.

Pioneer Technology was formed by the founders of Pioneer Medical, a 28 year old healthcare technology and service company. While developing a combined therapy of Hyperbaric Oxygen (HBO2) and Negative Pressure Wound Therapy (NPWT), Pioneer discovered the benefits of Sorbact® in conventional NPWT and general wound care. Pioneer has assembled a group of experts from the fields of science, medicine, and business that have successfully launched and led many companies in the healthcare field. Pioneer is using a slightly different technique than KCI, which utilizes the standard NPWT.

The primary objective is to create a model which tests and compares the fluid dynamics of all three dressing interfaces subjected to various environments. Variables may include liquid viscosity, various saturation points, gas versus liquid, timing, and flow rates, achieving various static pressures within a sealed environment. The goal is to substantiate the effective pressure distribution through the Sorbact dressing interface.

As a secondary objective, it is worth noting the difference in rigidity between foam, gauze and Sorbact. Because of this difference, it would be worthwhile to investigate the necessary pressure to achieve optimal macro-strain and micro-strain.

3. History and Context

Sorbact is a commercially sold wound dressing sold by Pioneer Technology that is currently being used in many hospital settings and was just patented this year. It can be used as a wound

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filler for NPWT or simply as a typical wound dressing. Sorbact is ideal for the treatment of wounds because it protects the wound, removes fluid that is filtered from the circulatory system into lesions or areas of inflammation and reduces the number of pathogenic microorganisms without using antimicrobial substances. The Sorbact pads consist of folded

acetate gauze treated with fatty acid ester DACC (dialkyl carbamoyl chloride) so that the pads have a strong hydrophobic property. Hence, pathogenic microorganisms in the wound surface can adhere to the pad. The wound dressing used is a bacteria-adsorbing composition in water insoluble form (Smith et al, 2010). Sorbact is found to be a better material for covering wounds that allows for quicker healing with a reduced chance of infection.

Figure 1 depicts the process by which we will create a model which tests and compares the fluid dynamics of all three dressing interfaces utilizing NPWT. As shown in Figure 2, we are attempting to model a human system consisting of an open wound on the forearm. We have outlined different possibilities for creating our ideal system and are currently consulting two professors of engineering at Vanderbilt University.

Figure 2: Model of human forearm with wound and NPWT dressing

Figure 1: Concept Diagram for Negative Pressure Wound Therapy

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4. Team

Our team consists of three well-qualified undergraduates in Biomedical Engineering as well as a collection of experts to assist and advise on system design, wound healing, negative pressure wound therapy and most importantly, fluid dynamics.

Lora Aboulmouna is a member of the design team. She has experience working with steam pressure systems with the Air force, examining pressure and fluid flow through pipelines. Lora also has experience with mathematical modeling of flow systems. Lora will be involved with researching each dressing and designing the optimal system for testing the desired flow characteristics of each wound dressing.

Ryan Frye is also a member of the design team. She is well versed in the healthcare field and has experience changing wound dressings. Ryan has dealt intimately with systems engineering through her work in her minor, Engineering Management, specifically with incremental changes to systems. Ryan will be involved with determining the best method of capturing the fluid dynamics data for each wound dressing.

Lisa Lewicki has worked intimately with clinic testing using animal models. She also has experience designing and working with mathematical models of flow in tubes. Lisa has a strong background in statistical analysis and will be analyzing the obtained data and determining whether there is a significant difference in the fluid dynamics of each material.

Craig Bullington, an undergraduate in Chemical Engineering, will be aiding the core project team. Craig has a strong background in fluid dynamics and will be advising the team on the proper variables to measure and control when considering the fluid dynamic properties of each material.

Josh Smith is our team’s liaison with Pioneer Technology, who holds to rights to the Sorbact wound dressing material. Josh was the principal inventor for the patented negative pressure wound therapy technique involving Sorbact. Josh will be advising the team on the application of negative pressure wound therapy and the proper use of the three materials in this therapy.

Dr. Robert Galloway is a professor of Biomedical Engineering, Surgery and Neurological Surgery at Vanderbilt University. In addition, Dr. Galloway serves as the director for the Center of Technology-Guided Therapy. Dr. Galloway will be advising in the design of a controlled system to test the fluid dynamics for each wound dressing.

Dr. Amanda Lowery is an assistant professor in the practice of Biomedical Engineering at Vanderbilt University. She has taught a course in biomaterials that included the mechanisms of wound healing. Dr. Lowery will be advising the team on the biologics associated with wound healing and micro and macro strain.

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5. Work Plan and Outcomes

Negative Pressure Would Therapy is something which has been around for 100s of years, but has only been commercialized in the last twenty years. The market for the dressing interface that is used in conjunction with NPWT is a billion dollar market. The commercial outcome which is hoped to be achieved is obtaining a large share of the market. This share of the market can be obtained by proving that the Sorbact is a competing product due to its fluid dynamics and additional benefits. The educational outcomes that are hoped to be achieved include uncovering a better material for covering wounds that allows for quicker healing with a reduced chance of infection.

The process that will be followed by the design team is a simple step-by-step procedure. An initial meeting will be arranged to determine the specifications of the project. Following the initial meeting, extensive research will be conducted to develop an advanced knowledge on negative pressure wound therapy, saturation, micro-strain, fluid flow, viscosity, and benefits and consequences of using gauze, foam, and Sorbact. Possible materials to use for the prototype will also thoroughly be researched and analyzed. Once the design team has a solid foundation of knowledge, the team will seek professional guidance for collaboration. Once design specifications have been developed, the materials for the prototype will be obtained and then the prototype will be developed. Tests will then be conducted to test the fluid dynamics of the gauze, foam, and Sorbact wound dressings. The success of the tests will be analyzed and the necessary alterations will be made to the prototype. Additional testing will be conducted and then the results will be analyzed. A comparison between the three wound dressings will be made and conclusions will be developed concerning the fluid dynamics, benefits, and consequences of each of the materials. At the close of the project, a presentation will be given to preset findings. Table 1 lists the tasks of the Project and a Gantt chart for the project can be found in the Appendix. The milestones of this project include creating design specifications, creating a prototype, conducting the necessary tests, and drawing conclusions from the data obtained.

The success of this project will open up the doors for a new product to come into the market of wound dressings. Being able to prove that the Sorbact not only works as well as the foam dressing but also has additional benefits, such as being antibacterial, will allow the market to turn towards a new era of materials. This project will succeed for two main reasons. The first reason is because the Sorbact has already shown promising success, and secondly, the individuals behind this project are dedicated to making it a success and will work relentlessly to prove that Sorbact is an integral tool in improving healthcare.

Table 1: Gantt Chart Tasks

Task # Task1 Initial Meeting with Mr. Smith, an employee of Pioneer Technology2 Initial Research2A Research: Negative Pressure Wound Therapy2B Research: Benefits/ Consequences of Gauze, Foam, & Sorbact2C Research: Saturation & Micro-strain2D Research: Fluid Flow and Viscosity2E Research: Materials and Prototype

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3 Seek Professional Guidance3A Seek Guidance: Meet with Dr. Bob Galloway, a Professor of BME at Vanderbilt3B Seek Guidance: Meet with Mrs. Amanda Lowery, a Biomaterial Specialist3C Seek Guidance: Follow up Meeting with Mr. Smith4 Develop Design Specifications5 Oral Presentation 16 Obtain Materials for Prototype6A Obtain Materials: Arm6B Obtain Materials: Fluids6C Obtain Materials: Wound Dressings6D Obtain Materials (or develop): Vacuum7 Create Prototype8 Test Fluid Dynamics of Three Materials9 Make Necessary Alterations to Prototype10 Conduct Additional Testing11 Oral Presentation 212 Analyze/ Compare Dynamics of 3 Materials13 Develop Conclusions Concerning Fluid Dynamics of Materials14 Final Poster Presentation to Present Findings

6. Evaluation and Sustainability Plan

Measuring success in our analysis involves obtaining sufficient data to suggest that the Sorbact material has equivalent or improved fluid dynamic properties to the current KCI foam application and the surgical gauze. Through our controlled system we will be testing saturation point, flow rate and pressure distribution.

Success in terms of the variables outlined above would result in a greater flow rate for the Sorbact materials as compared to the others. This would allow better flow of exudate from the wound to prevent infection and build up of wound debris.

Sorbact material should also have a lower saturation point than the surgical gauze or the foam. A lower saturation point indicates a material capable of handling a larger amount of exudate, possibly reducing the frequency with which a wound dressing must be changed.

Finally, a successful outcome in terms of pressure distribution would be an even pressure distribution. Since the application of Sorbact involves balling the flat material up, even pressure distribution is of concern. The other materials, in particular the KCI foam, are cut to the size of the wound and applied as is, without any folding or “balling up,” which translates to inherently even pressure distribution. The goal of this analysis is to determine if the Sorbact material provides an equally even pressure distribution.

The results of our experiments will allow Pioneer to determine if Sorbact has similar flow and pressure distribution to the currently accepted KCI foam and better flow and pressure

8

distribution than surgical gauze. Pioneer will then be able to take this information and use it for marketing purposes, as well as important findings to send back to Sorbact’s inventors in Sweden.

7. References

Borgquist O, Ingemansson R, Malmsjö M. Wound edge microvascular blood flow during negative pressure wound therapy: examining the effects of pressures from -10 to -175 mmHg. Plast Reconstr Surg In press.

Ljungh, A, N Yanagisawa, and T Wadström. "Using the principle of hydrophobic interaction to bind and remove wound bacteria." Journal of Wound Care 15.4 (2006): n. pag. Web. 6 Nov 2010.

Smith, Jan, and Peter Robertsson. Method for Dressing a Wound. , 2010. Web. 27 Oct 2010. <http://www.google.com/patents/about?id=ApHVAAAAEBAJ&dq=sorbact>

8. Appendix

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8.1. Gantt Chart of Project Tasks for November 14, 2010 through December 20, 2010

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8.1. Gantt Chart of Project Tasks for December 20, 2010 through January 23,2010

12

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8.1. Gantt Chart of Project Tasks for January 23, 2010 through February 28,2010

13

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8.1. Gantt Chart of Project Tasks for February 28, 2010 through April 15,2010

14

8.2. Budget Template

15

DETAILED BUDGET

FROM (MM/DD/YYYY) TO (MM/DD/YYYY)

10/08/2010 04/15/2010

PERSONNEL (Applicant organization only) DOLLAR AMOUNT REQUESTED (omit cents)

NAMEROLE ONPROJECT

Months Devoted to

ProjectINST.BASE

SALARY

SALARYREQUESTE

DFRINGE

BENEFITS TOTAL

Lisa Lewicki Project Director 7 $40,000 $23,000 $4,600 $27,600

Lora Aboulmouna Research Specialist 7 $32,000 $18,600 $3,700 $22,300

Ryan Frye Design Specialist 7 $32,000 $18,600 $3,700 $22,300

SUBTOTALS $60,200 $12,000 $72,200CONSULTANT COSTSDr. Robert GallowayDr. Amanda Lowery

$6,000DURABLE EQUIPMENT (Itemize)Vacuum PumpArm Simulation MaterialsPressure SensorsFlow Monitors

$1,500SUPPLIES (Consumable; Itemize by category)Surgical GauzeKCI FoamSorbactFluid (with proper viscosity)Wound Sealing MaterialSaline

$400TRAVELN/A $0ALTERATIONS AND RENOVATIONS (Itemize by category)N/A

OTHER EXPENSES (Itemize by category)Misc. Expenses

$200

Total Direct Costs $78,800

Indirect Costs $7,880

Total Direct & Indirect Costs $86,680

8.3. Budget Justification

Personnel:

As full time students taking on a very detailed research project, compensation for time spent on the project is based off of typical salary ranges.

The Project manager, Lisa Lewicki, will work half time over the seven-month project, directing all aspects of the project, designing the prototype that will be used for testing, and testing the three materials in the completed prototype.

The research specialist, Lora Aboulmouna, will be conducting background research on past studies and consulting with specialists in each area of study required for the correct finalization of the project. Lora will assist in the set-up of the prototype and will analyze the data from the testing. She will also be working half time.

The design specialist, Ryan Frye, will assist in the design and modeling of the system as well as with the analyzing of the data after testing is complete. She will devote half time to the project.

Consultant Costs:

Dr. Robert Galloway is a professor of Biomedical Engineering, Surgery and Neurological Surgery at Vanderbilt University. In addition, Dr. Galloway serves as the director for the Center of Technology-Guided Therapy. Dr. Galloway will be advising in the design of a controlled system to test the fluid dynamics for each wound dressing. He will be consulted once every month.

Dr. Amanda Lowery is an assistant professor in the practice of Biomedical Engineering at Vanderbilt University. She has taught a course in biomaterials that included the mechanisms of wound healing. Dr. Lowery will be advising the team on the biologics associated with wound healing and micro and macro strain. She will be consulted periodically.

Durable Equipment:

The Vacuum Pump on its own, for it to be a durable model, is at the least $300. Quality of the machines used throughout the project is necessary since we are dealing with foundational data that will determine important factors for the resultant materials tested. Should be able to use building vacuum…

Arm Simulation Materials are dependent on the design of the model we choose. We are currently looking into designing our own model than purchasing a fully designed arm simulation. With this in mind, we need to consult Dr. Amanda Lowry in regards to biological effects.

Pressure Sensors and Flow Monitors will be used as needed to monitor the distribution of pressure throughout the wound site during the testing phase.

Supplies:

The supplies will need to be purchased in bulk in order for numerous testing to take place regarding the three wound dressings that will be tested. Material analysis will take place and saturation points will need to be recorded, requiring numerous material samples. This alone ranges from $40 to $83.

16

8.4. Resumes

17

8.4. Resumes

18

8.4. Resumes

19