update in wound management new technology options in managing chronic wounds n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Update in Wound Management: New Technology Options In Managing Chronic Wounds PowerPoint Presentation
Download Presentation
Update in Wound Management: New Technology Options In Managing Chronic Wounds

Loading in 2 Seconds...

play fullscreen
1 / 34

Update in Wound Management: New Technology Options In Managing Chronic Wounds - PowerPoint PPT Presentation


  • 133 Views
  • Uploaded on

Update in Wound Management: New Technology Options In Managing Chronic Wounds . S. Kwon Lee, MD FACS FCCWS. MIST Therapy ® System Therapeutic Ultrasound. MIST Therapy Is Different From Other Ultrasound Devices. MIST THERAPY IS AN EVIDENCE BASED ADVANCED MODALITY THAT : .

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Update in Wound Management: New Technology Options In Managing Chronic Wounds' - Sophia


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
update in wound management new technology options in managing chronic wounds

Update in Wound Management: New Technology Options In Managing Chronic Wounds

S. Kwon Lee, MD FACS FCCWS

slide2

MIST Therapy® SystemTherapeutic Ultrasound

MIST Therapy Is Different From Other Ultrasound Devices

slide3

MIST THERAPY IS AN EVIDENCE BASED ADVANCED MODALITY THAT:

  • Promotes Wound Healing
  • Promotes New Cell Growth
  • Removes Bacteria
  • Cleans & Debrides
  • Painless
promotes wound healing
Promotes Wound Healing

“The MIST Therapy System produces a low-frequency, ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria.”

apwt promotes new cell growth
APWT Promotes New Cell Growth

MIST Therapy is a healing device for wounds and uses acoustic pressure to stimulate new cell growth. The cell walls of healthy human tissue cells, when put under stress will proliferate at a much faster rate. Studies show that when the acoustic pressure from MIST Therapy hits healthy cells, they become elongated and deform, causing a greater mitotic response of new healthy cells.

removes bacteria
Removes Bacteria

“Mist Therapy also uses acoustic pressure to remove bacteria. Unlike healthy tissue cells, the cell walls of bacteria are hard, like egg shells, and studies have shown that bacteria cells break apart and are destroyed when the acoustic pressure from a MIST Therapy treatment comes in contact with them.”

cleans debrides
Cleans & Debrides

“Although not a primary debridement tool, MIST Therapy helps to remove yellow slough, fibrin, necrotic tissue, and bacteria. This is especially helpful and beneficial in the removal of biofilm that often “stalls” the healing process in wounds.”

painless
Painless

“Since MIST Therapy is a noncontact and a nonthermal ultrasound device, it is also a painless procedure. It is one of one six products and one of only three devices cleared by the FDA allowed to say in its clearance statement that it promotes wound healing.”

mist therapy system product description
MIST Therapy® SystemProduct Description

MIST Therapy System Components

Generator & Transducer

Generator

MIST

Therapy

System

Transducer

9

ML-66103_A 4/2/07

mist therapy system product description1
MIST Therapy® SystemProduct Description

MIST Therapy Applicator Kit Components

Applicator & Sterile Saline (100 ml)

Chux Pad & Anti-Microbial Wipes

Applicator Kit

Applicator, Saline, Chux Pad, Wipes

10

ML-66103_A 4/2/07

mist therapy system product description2
MIST Therapy is Easy to Use

Easy Set Up

Assemble saline bottle & applicator onto transducer

Select treatment time & begin treating the wound

Short Treatment Time

Average of 5 minutes

Range of 3-20 minutes

Minimum Treatments of 3 times per week

Easy Clean Up

Discard applicator, saline bottle, and chux pad

Wipe transducer & generator with anti-microbial wipes

MIST Therapy® SystemProduct Description

11

ML-66103_A 4/2/07

mist therapy system fda clearance and indications for use
MIST Therapy System FDA Clearance

510(k) Clearance June 2005

“The MIST Therapy System produces a low frequency ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria”

MIST Therapy® SystemFDA Clearance and Indications for Use

12

ML-66103_A 4/2/07

mist therapy system fda clearance and indications for use1
MIST Therapy® SystemFDA Clearance and Indications for Use

The MIST Therapy System FDA Clearance is Not Wound Specific

13

ML-66103_A 4/2/07

slide14
Contraindications

Do not use near electronic implants / prosthesis

Near or over the heart or over the thoracic area if the patient is using a cardiac pacemaker

On the lower back during pregnancy or over a pregnant uterus

Over areas of malignancies

MIST Therapy® SystemProduct Description

14

ML-66103_A 4/2/07

slide15

MIST Therapy® SystemGeneral Therapeutic Ultrasound

This drawing depicts the effects of low frequency, non-contact, non-thermal ultrasound on human fibroblasts

  • Please note the cavitation on and near the cell surface
  • Please note the acoustic microstreaming along the cell surface

15

The mechanism of action of MIST Therapy has not been established in clinical trials.

This is an illustration only. This drawing is meant to illustrate the concepts of cavitation and acoustic microstreaming.

ML-66103_A 4/2/07

mist therapy system evidence based wound care
Randomized Clinical Trials

Efficacy of MIST Therapy for the Treatment of Diabetic Foot Ulcers. Dr. Ennis

Efficacy of MIST Therapy for the Treatment of Non-Healing Leg and Foot Ulcers Associated with Limb Ischemia. Dr. Kavros

Observational Registries

Effectiveness of MIST Therapy in Chronic Foot and Leg Ulcerations. Dr. Kavros

Effectiveness of MIST Therapy for the Healing of Chronic Wounds. Dr. Ennis

Evaluate the effectiveness of MIST Therapy System with Illinois Healthcare and Family Services

Cellular Stimulation Studies

Physiological Effects of Ultrasound MIST Therapy on Fibroblasts. Dr. Lei

Effects of MIST Therapy on Fibroblastic Migration Rates. T. Conner-Kerr

Bacteria Reduction Studies

Effects of MIST Therapy on Bacterial Levels in a Chronic Wound Bed. Dr. Kavros

Effects of MIST Therapy on Common Bacterial Wound Pathogens. Dr. Kavros

MIST Therapy® SystemEvidence-Based Wound Care

Growing Body of Evidence

16

ML-66103_A 4/2/07

slide17
Evidence-Based Leadership

Celleration conducted this study to provide wound care professionals the data needed to make evidence-based treatment decisions

Outcomes

Significant Benefit with use of MIST Therapy compared to the sham control

40.7% v. 14.3% at 12 weeks, p = 0.036

Published in a Peer-Reviewed Journal

Ostomy / Wound Management, 2005; 51 (8) 24-39

MIST Therapy® SystemEvidence-Based Wound Care

Randomized, Multi-Center, Double-Blind, Sham Controlled Clinical Trial

Primary Endpoint

  • Complete Wound Healing (without Drainage) in Diabetic Foot Ulcers

Principal Investigator

  • Dr. William Ennis

Study Design

  • The vascular status was standardized
  • Off-loading was requested with fixed ankle walkers and diabetic socks were provided
  • Patients required to ambulate 75% of time
  • Both groups received the same moist wound healing dressing protocol

17

ML-66103_A 4/2/07

slide18

MIST Therapy® SystemEvidence-Based Wound Care

Significant Benefit with MIST Therapy

Complete Wound Closure Without Drainage

P = 0.036

40.7%

14.3%

18

Ultrasound Therapy for Recalcitrant Diabetic Foot Ulcers: A randomized, double blinded, sham-controlled, multi-center study - Ostomy/Wound Management , 2005;51(8)24-39

ML-66103_A 4/2/07

slide19
Primary Purpose of the Study

Investigate the Effect of MIST Therapy on Non-Healing Leg and Foot Ulcers Associated with Chronic Critical Limb Ischemia

Principal Investigator

Dr. Steven Kavros

Study Location

Mayo Clinic, Rochester, Minnesota

Study Design

Prospective, randomized, parallel controlled study

Control Arm received Mayo Clinic SOC

MIST Therapy with Mayo Clinic SOC

All patients had to have CCLI

End Point, 50% or greater in wound healing in 12 weeks

Assess predictive value of TcPO2 in wound healing with MIST Therapy

MIST Therapy® SystemEvidence-Based Wound Care

Randomized Clinical Trial

Outcomes

  • MIST Therapy with SOC gave 63% vs. 29% (p<0.001) in 50% or greater in wound healing
  • Failure to achieve 50% or greater was 37% vs. 71% in MIST/SOC arms
  • Predictive value of TcPO2 demonstrates trend in non-healing wounds in CCLI

Accepted for Publication

  • Advances in Skin and Wound Care, December, 2006

19

ML-66103_A 4/2/07

slide20

MIST Therapy® SystemEvidence-Based Wound Care

Mayo Clinic Study: Limb Ischemia and MIST Therapy (12 week outcome)

63%

29%

20

ML-66103_A 4/2/07

slide21
Results of Fibroblast Study #1

Cellular Stimulation

Fibroblasts migrate 30-35% faster

T. Conner-Kerr, Ph.D, PT. CWS, East Carolina University, Greenville, NC

Results of Fibroblast Study #2

Cellular Stimulation

Growth factor release, TGFb & KGF

ERK/JNK ratios support cellular repair

J. Lai, DPM & M. Pittelkow, MD, Department of Dermatology, Mayo Clinic

MIST Therapy® SystemEvidence-Based Wound Care

21

ML-66103_A 4/2/07

slide22

MIST Therapy® SystemEvidence-Based Wound Care

Control

(2 minutes, 30 seconds of treatment with saline)

Staphylococcus aureus

MIST Therapy

(2 minutes, 30 seconds of treatment with saline and low frequency non contact ultrasound)

SEM*

TEM†

22

* SEM (scanning electron microscopy)

† TEM (transmission electron microscopy)

ML-66103_A 4/1/07

slide23

MIST Therapy® SystemEvidence-Based Wound Care

Control

(2 minutes, 30 seconds of treatment with saline)

MRSA (Methicillin-resistant Staphylococcus aureus)

MIST Therapy

(2 minutes, 30 seconds of treatment with saline and low frequency non contact ultrasound)

SEM

TEM

23

* SEM (scanning electron microscopy)

† TEM (transmission electron microscopy)

ML-66103_A 4/1/07

slide24

MIST Therapy® SystemEvidence-Based Wound Care

Control

(2 minutes, 30 seconds of treatment with saline)

Pseudomonas aeruginosa

MIST Therapy

(2 minutes, 30 seconds of treatment with saline and low frequency non contact ultrasound)

SEM

TEM

24

* SEM (scanning electron microscopy)

† TEM (transmission electron microscopy)

ML-66103_A 4/1/07

slide25

MIST Therapy® SystemEvidence-Based Wound Care

Control

(2 minutes, 30 seconds of treatment with saline)

VRE (Vancomycin-Resistant Enterococcus)

MIST Therapy

(2 minutes, 30 seconds of treatment with saline and low frequency non contact ultrasound)

SEM

TEM

25

* SEM (scanning electron microscopy)

† TEM (transmission electron microscopy)

ML-66103_A 4/1/07

slide26
And Celleration is Just Getting Started …

Bacteria Characterization Studies

Multi-Center Human Bacteria Reduction Study

Midwestern University – Bacterial Effects

Mayo Clinic – Biofilm Effects

MIST Therapy® SystemEvidence-Based Wound Care

26

ML-66103_A 4/2/07

slide34

Summary

  • MIST is a Proven Healing Device
  • Heals Wounds Faster
  • Growing Body of Evidence
    • Randomized Clinical Trials
    • Observational Registries
    • Published in Peer-Reviewed Journals
  • Cellular Stimulation
  • Bacterial Reduction
  • Cleans, Debrides & Preps Wound Bed
  • Easy to Use
  • Economics are Compelling