KCI Connect Issue 1

KCI Connect
3600 of HealingTM
Volume 1 : Issue 1
Welcome to the first edition of KCI Connect – a newsletter to
share with you some remarkable patient outcomes, life changing
experiences and excellent clinical results experienced by the Healthcare
Providers through V.A.C.® Negative Pressure Wound Therapy.
We further wish to share with you advancement in wound care
technology in treating of complex wounds which are a challenge to
the healthcare providers across the country and the world.
Kinetic Concepts, Inc. - Delivering advanced
medical device technologies that enable
individuals to return to a healthier lifestyle.
I am happy that our first newsletter in India is being brought out at
the time of a very special celebration for KCI, the 35th anniversary
as a company. It is astounding to think of how much has been
accomplished since the company was founded in 1976 by Dr. Jim
Leininger. At 35, we celebrate both healing and regeneration.
We’re innovating like never before, our new yet to be introduced
products, V.A.C.ViaTM Negative Pressure Therapy System, V.A.C.UltaTM
Negative Pressure Therapy System, PrevenaTM Incision Management
System and ABTheraTM Open Abdomen Negative Pressure Therapy
System* are the perfect proof our innovation. We’re expanding to
more places around the world. We are taking areas that require new
thinking, rebuilding and addressing them with fresh ideas that make
our company great and built to last.
Kinetic Concepts, Inc. (NYSE: KCI) is a leading global
medical technology company devoted to the discovery,
development, manufacture and marketing of innovative,
high-technology therapies and products for the wound
care, regenerative medicine and therapeutic support
system markets. The KCI product portfolio offers healthcare
professionals and their patients, products for all care settings
with therapies that help improve patient outcomes while
reducing the overall cost of care.
KCI is not just built on one product; it is built on a portfolio of
offerings that concentrate on providing solutions and addressing
specific need through the 3 business divisions – Active Healing
Solutions™ (AHS), Therapeutic Support Systems (THS) and LifeCell™*.
KCI was founded in 1976 by Dr. Jim Leininger who, as an
emergency room physician, pioneered the use of “kinetic”
or motion therapy to dramatically improve the survival rates
for patients who are immobile due to critical injury. Today,
KCI develops therapeutic support systems that address a full
range of specialized patient needs, including products for
the wound care, bariatric and critical care markets. In 1996,
KCI introduced an innovative approach to the treatment
and management of serious, complex wounds through
the use of sub-atmospheric or negative pressure. Known
today as “negative pressure wound therapy” (NPWT) KCI’s
proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy
System has changed the advanced wound care market and
remains the most clinically proven negative pressure wound
therapy product for the treatment and management of
complex, hard-to-heal wounds, ulcers, and partial thickness
burns.
It’s an interesting fact that over the past 15 years, more than 4 million
patients worldwide have been treated with V.A.C.® Therapy and more
than 2000 patients have been treated since the launch in India in
October 2010 with the V.A.C.® System.
Looking ahead, we are excited to get the new products from the
Active Healing Solutions™ portfolio and mattress replacement system
and overlays from the Therapeutic Support Systems portfolio that
highlight the company’s commitment to innovative therapies; the new
product lines from the AHS Business - Prevena™ Incision Management
System & ABThera™ Open Abdomen Negative Pressure Therapy
System will improve the portability and adoption of V.A.C.® Therapy,
while further expanding the clinical application of Negative Pressure.
I am delighted to share with you that we will be soon introducing
homecare services to address the growing Chronic Wound segment
(Diabetic Foot Ulcer and Pressure Ulcer) in India.
I would like to thank all clinicians and business partners for their
support to KCI Medical India. I hope you enjoy reading this newsletter,
and we look forward to sharing more positive experiences with you in
the future via this newsletter and through our partnership with you in
wound healing.
Sajiv S
Director - Commercial
*LifeCell™ Products, V.A.C Via™, V.A.C Ulta™ Prevena™ and ABthera™ are not
yet registered for Sale in India.
A History of Innovation
Product Range
KCI products address a full range of patient needs and are
used by healthcare professionals around the world in a wide
range of care settings, including acute care hospitals, longterm care and skilled nursing facilities, home health agencies
and wound care clinics.
Active Healing Solutions™ — The KCI V.A.C.® Therapy
System is indicated for promoting wound healing through
specific mechanisms of action such as preparing the wound
bed for closure, reducing edema, promoting granulation
tissue formation and perfusion, and removing exudate and
infectious materials.
Regenerative Medicine — KCI entered the fast-growing
tissue regeneration market in 2008 with the acquisition
of LifeCell Corporation, a leading provider of human
and porcine-based tissue regeneration products. LifeCell
develops and markets products for use in reconstructive,
orthopedic and urogynecologic surgical procedures utilizing
its AlloDerm® Regenerative Tissue Matrix and Strattice™
Reconstructive Tissue Matrix products. These products are
not available for sale in India.
KCI’s proprietary V.A.C.® Therapy System has
revolutionized the way in which caregivers treat the most
serious, complex wounds. V.A.C.® Therapy utilizes an opencell polymer foam dressing that conforms to the wound
bed under negative pressure. The therapy system creates a
unique wound healing environment that has been shown
to promote the wound healing process, reduce edema,
prepare the wound bed for closure, promote the formation
of granulation tissue and remove infectious materials.
Therapeutic Support Systems — The TSS product
portfolio includes a full range of specialty hospital beds,
mattress replacement systems and overlays designed
to address pulmonary complications associated with
immobility, reduce skin breakdown, and assist caregivers in
the safe and dignified handling of bariatric patients.
• TheInfoV.A.C.® Therapy System is designed for patients in
the acute care setting.
Research and Development (R&D) — KCI continues
to invest in innovation with an ongoing commitment to
research and development aimed at improving patient
outcomes while reducing the overall cost of care. In 2010,
KCI invested approximately $90 million in its R&D efforts,
which are managed by approximately 150 clinical research
and development professionals.
Clinical Evidence
KCI’s V.A.C.® Therapy System enjoys an unprecedented body
of clinical evidence that demonstrates clinical efficacy and
cost-effectiveness, with over:
• TheActiV.A.C.® Therapy System is designed for
ambulatory patients and is used primarily in the home
care setting.
• 825V.A.C.® Therapy Articles
• 675Peer-ReviewedV.A.C.® Therapy Articles
• 164V.A.C.® Therapy Articles-Not English
• 50Peer-ReviewedV.A.C.® Therapy Articles-Not English
• 825V.A.C.® Therapy Abstracts
• 525V.A.C.® Therapy Related Articles
• 71V.A.C.® Therapy Book References
• 12V.A.C.® Therapy Veterinary Articles
* as of 8th August, 2011
Contents:
Page 3 - Vacuum Assisted Closure Therapy (V.A.C.®)
Page 6 - Case Study
Page 7 & 8 - Interface with Surgeons
Page 8 & 11 - Patient Testimonials
Page 10 - Case Study
Page 12 - Basic V.A.C.® Dressing application guide
Page 13 - Skin Grafts
Page 14 - Case Studies
2
Vaccum Assisted Closure Therapy (V.A.C.®) :
Innovation in Wound Care
V.A.C.® Therapy is recognized as a significant, clinically
proven advancement in wound care that promotes active
wound healing at the cellular level.
Since its introduction, V.A.C.® Therapy has changed the way
wounds are healed.
V.A.C. Therapy promotes wound healing through Negative
Pressure Wound Therapy (NPWT). By delivering negative
pressure (a vacuum) at the wound site through a proprietary
dressing, wound edges are drawn together, infectious
materials are removed and granulation tissue and perfusion
are promoted.
®
The V.A.C.® Therapy system (V.A.C.® Therapy) is used
in a wide variety of wound types including acute wounds,
traumatic wounds, sub-acute wounds, dehisced wounds,
chronic wounds, ulcers (diabetic, venous stasis and pressure
ulcers), partial thickness, burns, flaps and grafts.
2. SensaT.R.A.C.™ Technology
T.R.A.C.TM Technology
regulates pressure
at the wound site
to ensure delivery of
prescribed therapy
settings.
1
2
3
3. V.A.C.®
GranuFoam™
Dressings
V.A.C.® GranuFoamTM Dressings under negative pressure
actively induce macrostrain and microstrain. The 400-600
micron, reticulated pores also help distribute pressure in the
wound bed.
How V.A.C.® Therapy Promotes Wound Healing
Understanding the Science of V.A.C.® Therapy
The Science behind the System:
It’s a proven therapy with over 675 peer-reviewed articles
documenting the clinical and economic benefits of V.A.C.®
(Vacuum Assisted Closure®) Therapy. However, it is equally
important to understand how V.A.C.® Therapy works to
achieve these outcomes.
Under negative pressure, V.A.C.® Therapy with proprietary
V.A.C.® GranuFoamTM Dressings applies mechanical forces to
the wound to create an environment that promotes wound
healing. These forces are known as Macrostrain (Physicial
response) and Microstrain (Biological response).
What Makes Up the V.A.C.® Therapy System Three Critical Components, One Unique System:
Macrostrain is the visible stretch that occurs when negative
pressure contracts the foam.
The V.A.C.® Therapy System is comprised of three essential
components actively working together to help promote
wound healing.
•Itdrawswoundedgestogether.
•Providesdirectandcomplete wound bed contact
•Evenlydistributesnegative
pressure
•Removesexudateandinfectious
materials
1. V.A.C.® Therapy Unit
The V.A.C.® Therapy unit utilizes sophisticated software
algorithms to provide intermittent and continuous negative
pressure to the wound with integrated patient safety
features.
Microstrain is the microdeformation
at the cellular level, which leads to cell
stretch.
•Reducesoedema
•Promotesperfusion
•Promotesgranulationtissue formation by facilitating cell migration and proliferation
V.A.C.® Therapy Units
GranuFoamTM Dressings
SensaT.R.A.C.TM Technology
™
3
A bench study* showed that when a simulated wound
model was lowered 36 inches (91 cm) below the
vacuum pump, the pressure drop was significantly less
(p=<.005) using V.A.C.® Therapy with SensaT.R.A.C.TM
and GranuFoamTM Dressing than NPWT with gauze
or NPWT with reticulated open cell foam without the
benefit of regulated pressure feedback and control from
SensaT.R.A.C.TM Technology.
V.A.C.® Dressing Technology
The V.A.C.® GranuFoamTM Difference: The Science of
Cellular Wound Healing
The unique pore structure of V.A.C.® GranuFoamTM
Dressings actively helps promote healing at the cellular level.
Each tiny pore delivers the necessary mechanisms critical to
wound healing.
•Under negative pressure, actively promotes tissue granulation at the cellular level
•Flexible design adapts to the contours of deep and irregularly shaped wounds
•400 – 600 micron pore sizes help provide uniform distribution of negative pressure (NP) at the wound site
•Hydrophobic pore structure helps facilitate exudate and infectious material removal
•Compresses to less than half its size under negative pressure to help draw wound edges together
SensaT.R.A.C.
TM
Technology
An Essential Component of V.A.C.® Therapy
*McNulty A, Spranger I, Courage J, et al. The Consistent Delivery of Negative Pressure
to Wounds Using Reticulated, Open Cell Foam and Regulated Pressure Feedback.
WOUNDS 2010;22(5):114-120
What is SensaT.R.A.C.TM Technology?
SensaT.R.A.C.TM Pad
•Distributes negative pressure to individual sensing lumens
•Helps reduce tubing blocks and false alarms though enhanced fluid dynamics
•Enhances patient comfort with a low profile design
SensaT.R.A.C.TM Tubing
•Efficiently draws exudate away from the wound through the large inner lumen
•Independently monitors target pressure at the wound through the outer sensing lumens
•Allows for secure and convenient tubing connections
V.A.C.® Therapy is the only NPWT system that monitors
pressure at the wound site and adjusts accordingly.
This is achieved through proprietary SensaT.R.A.C.TM
Technology that ensures the prescribed negative pressure is
maintained for optimal healing outcomes.
Only SensaT.R.A.C.TM Technology compensates for pressure
variances at the wound site due to patient position,
movement and exudate characteristics.
4
Monitoring Software
•Continuously monitors or regulates negative pressure at the wound site
•Maintains prescribed negative pressure at the wound site by adjusting pump output
•Safety alarms alert caregivers if target pressure is not met or therapy is interrupted
Efficacy of the Therapy – Therapeutic Outcomes
The V.A.C.® Therapy System addresses key wound healing
factors, especially in the inflammatory and proliferative
phases of wound healing. The clinical and cost effective
outcomes demonstrated in V.A.C.® Therapy’s extensive
body of evidence are a direct result of the system’s unique
functions and mechanisms of action as supported by
scientific research.
– V.A.C.® Therapy prepared the wound bed over twice
as fast compared to advanced moist wound dressings.
Time to wound bed preparation is shown to be reduced
from 17 days to 7 days with V.A.C.® Therapy1
– V.A.C.® Therapy significantly reduced time of wound
healing in the treatment of Diabetic Foot Ulcers
compared to advanced moist wound dressings, AMWD
(V.A.C.® Therapy = 96 days, AMWD >112 days)2
V.A.C.® Therapy: Helps Improve Quality of Life3
V.A.C.® Therapy has proven to provide overall significant
improvement in a patient perceived quality of life
A German patient review conducted by Augustin et al,
in response to a request from the Institute for Quality for
Economics in Healthcare (IQWIG) to evaluate medical devices
from a patient’s perspective, showed a significant positive
improvement in quality of life from V.A.C.® Therapy in the
following ways:
How V.A.C.® Therapy Removes Barriers to Healing
•Improvedmobility
•Increasedindependence
•Fasterreturntosociallifeandwillingtomixwithothers
•Reducedpainanddiscomfort
•Reduceddepressionandfeelingsoffear
V.A.C.® Therapy creates an environment that promotes
wound healing through the following mechanisms:
Wound Healing Barrier
V.A.C.® Therapy Mechanism
Excess bacterial burden
Inadequate protection
against infection
Excess exudate
Excess edema (interstitial fluid)
Absence of moisture
Lack of adequate blood flow
Lack of granulation tissue
Removes infectious materials
Provides protected wound healing
environment
Removes exudate
Reduces edema (interstitial fluid)
Provides a moist wound healing
environment
Promotes perfusion
Removes barries to cell migration and
formation
proliferation
V.A.C.® Therapy - Cost Effectiveness
Several clinical studies demonstrate that V.A.C.® Therapy
can result in fewer adverse events, which results in fewer
hospitalizations, less emergent care incidents, reduced
complications, fewer amputations, less dressing changes,
decreased personnel commitments, shorter hospitalization,
and reduced treatment times.
Early use of V.A.C.® Therapy is both clinically efficacious
and cost effective compared to application at later points
in wound therapy. Compelling results show that V.A.C.®
Therapy has the accelerated potiential to wound healing
and therefore help reduce the cost of treatment. V.A.C.®
Therapy can help reduce both direct treatment cost and
nursing time expenses.
V.A.C.® Therapy is supported by the following clinical
evidence to demonstrate its ability to deliver fast and
effective results:
Quality of Life before and After V.A.C.® Therapy
With more than four million patients treated worldwide,
only V.A.C.® Therapy delivers the proven clinical and
economic outcomes caregivers can trust.
References:
1
Vuerstaek JD, et al. J Vasc Surg 2006; 44: 1029-37.
Blume, et al. Comparison of Negative Pressure Wound Therapy (V.A.C. Therapy)
to Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers – a
Multicenter Randomized Controlled Trial. Diabetes Care, 2008
2
Augustin M, Zschoke I. [Evaluation of patient benefits of ambulatory and stationary
use of V.A.C.® Therapy]. MMW-Fortschritte der Medizin Originalien Nr.1 2006;
148:S25-32.
3
™
5
Case study
Degloving Injury of
Right Thigh from Vehicle
Accident
further debrided of non-viable muscle and skin. The sartorius
muscle was brought forward to cover the femoral artery in
the mid-thigh region before it entered the adductor canal
(Figure 3).
Patient
A 22-year-old male was admitted 7 hours post motor vehicle
accident involving his motorbike. He fell and was dragged a
few meters in a prone position.
Diagnosis
At initial examination, the patient’s vitals were stable.
Extensive degloving of his right thigh extended from the
groin to the knee. The entire rectus femoris muscle was lost.
The femoral triangle was open, with the pulsating femoral
artery clearly visible. The wound was grossly contaminated,
and there were no broken bones (Figure 1).
Figure 3. The sartorius muscle was brought forward to cover the femoral
artery. The artery forceps point to the vessels
On hospital Day 4, the wound was re-inspected, and a
decision was made to initiate negative pressure wound
therapy (NPWT; V.A.C.® Therapy, KCI USA Inc., San Antonio,
TX) to promote wound healing.
V.A.C.® Therapy System Initiation
Figure 1. Degloving injury of right thigh at hospital admission
A single-layer of non-adherent dressing (Tulle Gras, Jelonet,
Smith & Nephew) was applied over the femoral vessels
to protect them during therapy and at dressing change
(Figure 4). The reticulated open-cell foam dressing (V.A.C.®
GranuFoam™ Dressing, KCI USA, Inc., San Antonio, TX)
was applied over the entire wound area. Negative pressure
was initiated at -125 mmHg. After 5 days of V.A.C.®
Therapy, clinicians determined that the wound was ready
for a split-thickness skin graft (STSG), and the therapy was
discontinued.
Wound Progress:
The wound was irrigated and debrided almost immediately
to excise all particulate matter and devitalized tissue. During
initial examination, serious contamination at the base of the
scrotum was noted and debrided (Figure 2). At 48 hours,
second-look surgery was performed, and the wound was
Figure 4. Prior to V.A.C.® Therapy initiation, a non-adherent layer was
placed completely over the femoral vessels to protect them during V.A.C.®
Therapy and prior to each subsequent dressing change
Post-V.A.C.® Therapy Follow-up
6
Figure 2. Wound was debrided to base of scrotum
An STSG was placed on hospital Day 9. The graft took well,
and three weeks later, the wound was almost completely
healed with no complications (Figure 5).
Interface with
Surgeons
I am using V.A.C.® Therapy since its launch in India. It has been
more than 3 months now and I am very happy to see the results
of V.A.C.® therapy. I have seen remarkable progress in healing of
wound, it heals the toughest wounds in a very simple way and thus
reduces the overall time of the patients in the hospital.
V.A.C.® Therapy is really effective and I am glad to see Labindia
bringing the technology in India.
Figure 5. Three weeks following the graft, the wound was almost
completely healed
Discussion
V.A.C.® Therapy is an accepted method of treating
traumatic wounds. The goal of this adjunctive therapy is to
promote wound healing for closure, which was ultimately
accomplished by placement of an STSG. V.A.C.® Therapy
requires fewer dressing changes than gauze dressings and
is therefore more convenient for patients. Prior to initiating
V.A.C.® Therapy, debridement of necrotic tissue and
complete removal of eschar must be performed. In this case,
V.A.C.® Therapy permitted us to rehabilitate a patient with a
large, grossly contaminated wound within 20 days.
*Note: Prolonged time between dressing changes greater than
three days may cause growth of granulation tissue into the pores
of the foam and may cause some tissue damage during dressing
removal. In these cases, the author usually delays grafting by 24
hours so as to achieve hemostasis prior to grafting.
Reference
Sitaram Prasad, M. S., M. S.(Plast. Surg), D. N. B. (Plast. Surg)
Plastic Surgeon
Joy Hospital, Chembur
Fortis Hospital, Mulund (India)
Important: As with any case study, the results and
outcomes of this patient should not be interpreted as a
promise, representation or warranty of similar results.
Individual results may vary depending on the patient’s
circumstances and condition.
IMPORTANT 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.
Dr. Rakesh K. Khazanchi
Director
Division of Plastic, Aesthetic and Reconstructive Surgery.
Medanta – The Medicity, Gurgaon
I have used V.A.C.® Therapy on many occasions for the benefit
of my patients. The experience was very good and the results
of V.A.C.® Therapy are phenomenal. The number of V.A.C.®
Therapy users is growing rapidly in my current practice.
I must also mention that Labindia Healthcare has been very
helpful and have supported us wholeheartedly. The Labindia
team is efficient and very proactive.
I think and firmly believe that V.A.C.® Therapy has a great future
in the years to come in India.
Dr. Shrirang G. Pandit
M.B. M.S. M Ch.
Plastic & Reconstructive Surgeon, Cosmetic Surgeon,
Hand Surgeon, MicroSurgeon, Burns.
We have used V.A.C.® Therapy at our institute for our patients
suffering from Diabetic Ulcers. It is really a wonderful innovation as
it is saving limbs of many patients and on many occasions patients
have expressed their happiness with the comfort of V.A.C.®
Therapy. It is also user-friendly for both patients and the surgeons.
The support staff of Labindia Healthcare are rendering their services
to the utmost satisfaction of patients and doctors.
I wish them all the best in their future endeavours.
Dr. Pinjala Ramakrishna
Nizam’s Institute of Medical Sciences, Hyderabad
M.S., FRCS., FICS., FICA
Professor & Head., Dept. of Vascular Sugery
I have been using Negative Pressure Wound Therapy for more
than 2 years. I have found it very useful. It is beneficial in a
variety of cases. I recommend its usage after proper training and
for appropriate indications.
Clinical support from Labindia Healthcare is very good.
Dr. N. Jithendran
M.S. (Orthopedics)
M. Ch (Plastic Surgery), D.N. B. (Plastic Surgery)
Consultant Plastic and Reconstructive Surgeon
Aware Global Hospital, Hyderabad
7
Interface with
Surgeons
My past experience with V.A.C.® Therapy in UK showed remarkable
progress in healing wounds. I am glad to see the advent of V.A.C.®
Therapy in India as it will help me in providing better wound care
to my patients.
Dr. Niraj Vora
MS (Ortho), MRCS (Edin)
Consultant Orthopedic Joint Replacement and
Trauma Surgeon
Kokilaben Dhirubai Ambani Hospital
I have used V.A.C.® Therapy for the management of my patients
with foot crush injury. It worked well and we could manage the
wound in a better way. I am impressed with the service provided
by Labindia team. I will use the same system as and when
required.
Dr. Hitesh Laad
M.S., M. Ch., D.N.B. (Plastic Surgery)
Cosmetic & Mircovascular Surgeon
Aditya Birla Memorial Hospital
Chinchwad, Pune
Patient testimonials
Patient name – Mrs. Ghandhari Savarkar
Installed date – 16-May-2011
Hospital name – S.L.Raheja Hospital (home care patient)
Doctor Reference – Dr. Arun Bal - Diabetic foot surgeon.
“3 years ago I underwent an amputation of my toe on the left leg due
to a diabetic ulcer. Because of this experience I became aware of how to
take proper care of diabetic feet. However, 2 months ago, in spite of all
the care and precaution the condition of my right leg started worsening.
I therefore approached Dr. Arun Bal for my treatment. He was able to
save my toes but the wound continued to spread to the sole, it hardly
showed any sign of improvement. Doctor suggested me the option of
using KCI’s V.A.C.® Therapy. I was at ease during the complete course of
therapy, I did not experience any pain or discomfort during treatment.
3 canisters full of exudate i.e. 1.5 litres of exudate was removed during
the complete therapy, which could have easily taken 6 months with
normal dressings. The therapy also helped to prevent the wound from
getting infected.
The Service provided by KCI Medical India support team was prompt,
good and effective. They kept a daily check on the functioning of the
machine and also addressed the issue of leak and block of the machine
promptly. After 5 dressing changes my wound healed effectively, and
the grafting procedure was completely avoided. The surgeon advised
me to apply just normal dressings till my wound closure.”
Patient name – Mrs. C.R.Vijayalakshmi
Installed date – 19-May-2011
Hospital name – Apollo Hospital, Chennai (home care patient)
Doctor Reference – Dr. Sivaram Bharatwaj
Quick Facts
• V.A.C.® Therapy is contraindicated when osteomyelitis is left untreated
while present in the wound. However, once theosteomyelitis is treated
through antibiotic therapy and/or bone debridement, it is no longer
considered a contraindication for V.A.C.® Therapy. The wound will not
heal effectively unless the underlying infectious issue is addressed.
• When using V.A.C.® Therapy on patients with a large fluid loss, such
as those with the potential for abdominal compartment syndrome,
fluid management is an important clinical issue. V.A.C.® Canister
design allows for accurate measuring of fluid loss and thus may help
guide physicians in fluid management.
• V.A.C.® GranuFoamTM Dressing is hydrophobic, or moisture repelling,
and is also an open pore foam which allows for exudates removal.
It is less dense than V.A.C.® WhiteFoam and is reticulated, which means
all the pores are in communication with each other. This design
allows for distribution of negative pressure across the wound bed. It
works well on all types of wounds, tears more easily than WhiteFoam,
and is considered to be most effective in stimulating granulation tissue
formation.
• Precautionsshouldbetakenforpatients:
with active bleeding
with difficult wound haemostasis
who are taking anticoagulant medication.
8
“I am a cancer patient and I was on Chemotherapy for last 6 months.
During the chemotherapy process my lower abdomen was affected and
it dehisced. My wound was infected; it was very painful and had a bad
odour. Initially my wound was dressed with a normal gauze dressing, this
continued for almost 3 weeks but there were no signs of improvement
and it also started exudating heavily. I had to travel from my house to the
hospital every day for dressing changes. The distance to the hospital was
more than 20 kms. and it was very tedious to travel to the hospital every
day.
Dr.Sivaram Bharatwaj briefed me about KCI Medical’s V.A.C.® Therapy.
After 2 weeks of V.A.C.® Therapy we went for a follow-up check to
Dr.Sivaram Bharatwaj, he saw my wound and exclaimed ”Wow! We will
close the wound without the grafting”, I was very happy, and couldn’t
believe that my wound would heal in such a short span of time. After a
week my abdomen was closed. This therapy has changed my life and gave
me the confidence. It saved me from my stressfull and painful travel every
day from home to hospital. I wish that the benefits of V.A.C.® Therapy
reach every person who are in need.”
Patient Name – Mrs Mary
Age – 65 Years
Type of Wound – Diabetic Carbuncle
Doctor Reference – Dr. Philip Philip Puthumana (Plastic Surgeon)
Hospital – Little Flower Hospital, Angamaly
“I was being treated for a wound for two months but the wound was
getting worse day by day. Then Dr. Philip recommended us to use V.A.C.®
Therapy from KCI Medical. The wound showed good improvement within
10 days of therapy and on the 15th day I was back home”
Important: As with any case study and patient testimonials the results and outcomes of the patient should not be interpreted as a promise, representation
or warranty of similar results. Individual results may vary depending on the patient’s circumstances and condition.
Diabetic foot ulcers may lead
to Amputation.
What if it were your patient?
Clinical studies have shown that
V.A.C.® Therapy
may help save limbs and enable
individuals to return to a healthier lifestyle.1,2,3
•Approximately
•Within
85% of all amputations are preceded by a non-healing foot ulcer.4
five years following an initial amputation, up to 51% of diabetic amputees
undergo a second leg amputation.5
•69%
of diabetic amputees will not survive past five years.6
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.
1. Driver V., et al. Health Economic Implications for Wound Care and Limb Preservation. J Man Care Med 2008;11(1):13-19. 2. Blume PA, et al. Comparison of Negative Pressure
Wound Therapy Using Vacuum-Assisted Closure with Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers. Diabetes Care. 2008;31:631-636. 3. Armstrong
D, et al. Negative Pressure Wound Therapy after Partial Diabetic Foot Amputation: A Multicentre Randomised Controlled Trial. Lancet 2005;366:1704-10. 4. Mayfield JA, et al:
Preventive Foot Care in People with Diabetes. Diabetes Care, 21:2161-77, 1988.5. Reiber et al. Lower Extremity Foot Ulcers and Amputations in Diabetes. Available at http://
diabetes.niddk.nih.gov/dm/pubs/America/pdf/chapter18.pdf. Accessed {online} December 23, 2008. 6. Aulivola, et al. Major Lower Extremity Amputations; Outcome of a Modern
Series. Arch Surg., 2004; 139:395-399. Survival in patients with DM was 69.4% and 30.9% vs 70.8% and 51.0% in patients without DM at 1 and 5 years, respectively (P = .002).
© 2011 KCI Licensing, Inc. All rights reserved, All trademarks designated herein are proprietary to KCI Licensing. Inc., its affiliates and/or licensors.
This material is intended for healthcare professionals only. DSL#11-0071.IN.D2 (6/2011)
9
Case study
Infected, Post-Irradiation
Ulcer on Back
Patient
A 75-year-old male with a history of multiple myeloma
developed a compression fracture in vertebra D10 over one
year prior to presentation. Internal fixation was performed
to stabilize the fracture, and the patient was treated with
radiation therapy. Following irradiation, he developed a
chronic, non-healing back ulcer that became infected.
Diagnosis
The patient was admitted to the hospital with a postirradiation wound with fibrotic undermined edges. Pale,
fibrotic granulation tissue was present in the base of
the wound and pedicle screws were palpable (Figure 1).
A culture swab revealed mixed growth of organisms.
The sterile reticulated open-cell foam dressing (V.A.C.®
GranuFoamTM Dressing, KCI USA, Inc., San Antonio, TX)
was cut to the size of the wound and gently placed into the
wound cavity. A sterile adhesive drape was placed over the
foam and 5 to 7 cm of surrounding intact skin to ensure a
seal. A 2.5 cm hole was cut into the drape over which the
T.R.A.C.TM Pad (KCI USA Inc., San Antonio, TX) and tubing
were attached. The tubing was connected to a canister
that is attached to a negative pressure unit, and therapy
was initiated (Figure 2) at -125 mmHg intermittent pressure
(8 minutes on and 2 minutes off). Wound inspection and
dressing changes were performed at least twice weekly.
Figure 2. Application
of V.A.C.® Therapy at
-125 mmHg
After 10 days of V.A.C.® Therapy, the wound edges were no
longer undermined, granulation was improved, and scanty
serous discharge was noted (Figure 3). V.A.C.® Therapy was
discontinued and a flap (bipedicled advancement skin flap
with split skin graft to donor site) was used to cover the
defect.
Figure 1. Chronic
post-irradiation ulcer
prior to adjunctive
V.A.C.® Therapy
Wound Progress
This radiation ulcer had been open for over a year and
failed to show signs of significant healing with conservative
management (twice daily saline gauze dressing changes).
Appropriate antibiotics were administered. Several attempts
at wound closure had failed. A decision was made to initiate
negative pressure wound therapy (NPWT; V.A.C.® Therapy,
KCI USA Inc., San Antonio, TX) over the wound to prepare it
for flap closure.
10
Figure 3. Following
10 days of V.A.C.®
Therapy, wound
edges were no longer
undermined and
healthy granulation
tissue formed
Post-V.A.C.® Therapy Follow-up
At 4 weeks, the wound was fully closed with no
complications (Figure 4).
V.A.C.® Therapy System Initiation
Discussion
Prior to V.A.C.® Therapy administration, surface slough and
necrotic tissue were surgically removed, and the wound
was irrigated with normal saline. The peri-wound skin was
prepared (ie, shaved and cleaned with ether) and ensured to
be dry as well as free from grease and hair.
V.A.C.® Therapy was very useful in treating this chronic
ulcer. V.A.C.® Therapy helped achieve wound contraction
and early resolution of infection. Compared to twice daily
dressing changes, a reduction in pain perception was also
reported with V.A.C.® Therapy.
Patient testimonials
Patient’s Name – Mrs. A Lakshmy
Age – 58 yrs (Diabetic for the last 25+ years.)
Hospital Name – Mahavir Jain Hospital
Doctor Reference – Dr. K. R. Suresh
Figure 4. At 4
weeks following
flap (bipedicled
advancement skin
flap with split skin
graft to donor site),
the wound was
completely closed
“My mother had developed two ulcerations in her left foot, which was a
diagnosed as a Charcots Foot.
She was treated at Mahaveer Jain hospital for the same and initially
underwent surgical debridement for the ulcers. Post surgery, as the
wound was large Dr. Suresh advised her daily dressing for the next 6
-7 months. The doctors were also skeptical about the rate of healing of
the wound. Later Dr. Suresh suggested that there is another treatment
option called the V.A.C.® Therapy from KCI Medical
Although V.A.C.® Therapy has been shown to promote
perfusion in wounds, there are few publications describing
its effects in irradiation-induced ulcers.1,2 In a pilot study
of five patients, application of V.A.C.® Therapy led to
a significant decrease of HIF-1 alpha (hypoxia-inducible
factor-1 alpha) concentration, an indirect marker of tissue
oxygenation in irradiated wounds.2 V.A.C.® Therapy facilitated increases in oxygenation may play a role in
healing irradiation ulcers, but considerably more research is
needed to quantify these effects.
We took a decision to go ahead with V.A.C.® Therapy for treating my
mother’s wound. After three dressing changes, Dr. Suresh discontinued
the therapy, since the wound showed improvement and developed good
granulation. In just three dressings the healing that was observed, even
by a layman like me was amazing.
Though, we were suggested grafting, the suggestion of Aircast later
by another Doctor - Dr. Mallikarjun in Columbia Asia hospital helped
my mother and now the wound has healed completely without any
grafting.”
Patient Name – Mr. Surendra Singh
Hospital name – Mayo Hospital, Lucknow
Doctor Reference – Dr. Kunal Bhalla
Authors:
G Vishwanath, Mch (Plastic Surgery)
Saurabh Singh, MS (General Surgery)
Reconstructive Surgery Centre, INHS Asvini
Mumbai
KCI Medical Personnel explained the details of the V.A.C.® Therapy to us
in the hospital... I should really commend the way they dealt with us and
patiently answered all our questions.
“I would like to extend my deepest gratitude to the team of KCI Medical.
G Vishwanath
Loos B, Kopp J, Hohenberger W, et al. Post-malignancy irradiation ulcers
with exposed alloplastic materials can be salvaged with topical negative
pressure therapy (TNP). Eur J Surg Oncol. 2007 Sep;33(7):920-5. Epub 2007
Feb 7.
2
Grimm A, Dimmler A, Stange S, et al. Expression of HIF-1 alpha in
irradiated tissue is altered by topical negative-pressure therapy. Strahlenther
Onkol. 2007 Mar;183(3):144-9.
1
IMPORTANT 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.
I suffered from multiple femur fracture with a deep wound after an
accident. Doctors in MAYO Hospital conducted the orthopaedic surgery.
But the wound became infected with pus pockets. I am a known diabetic
for past 20 years, and that was the reason my wound worsened day by day.
At last Dr. Kunal Bhalla advised me to use V.A.C.® Therapy from
KCI Medical. The results were wonderful; the wound was clean and
granulating. After 3 dressings I completely recovered from my injury. I am
very happy about my present condition and once again I am very thankful
to the entire KCI team.”
Patient name – Mr. Ram Kumar Gautam
Hospital name – Cheema Medical Center
Doctor Reference – Dr. K. D. Aneja
“My father had a foot injury after he met with an accident.
At the start, it looked like any normal case and we felt that the wound
will heal normally. However the blood reports revealed that my father
was diabetic. Doctor applied a graft on the wound. However when the
wound dressing was opened after few days, doctor realized that the
graft was rejected. At this instance the doctors informed that further
worsening of the wound can result to amputation of the leg. Dr. Aneja
then suggested using KCI Medical’s V.A.C.® Therapy. We had to use
V.A.C.® Therapy for almost over a month. It took 8 dressings to prepare
the wound bed and make it conducive for re-grafting. Doctor applied
the graft and this time it was successful. My father’s foot is in much
better condition now. Thanks to KCI Team V.A.C.® Therapy has proved
to be a boon for us.”
Important: As with any case study and patient testimonials the results and outcomes of the patient should not be interpreted as a promise, representation
or warranty of similar results. Individual results may vary depending on the patient’s circumstances and condition.
11
Basic V.A.C.® Dressing Application Guide
Sensa T.R.A.C.TM Pad
V.A.C.® Drape
V.A.C.® GranuFoamTM
Dressing
Wound Bed
Step 1 - Assess wound size and type
Instruction for Use and Safety Information
This is a quick reference showing the basic steps in a typical
dressing application. As with any device, it is important to read and
understand the detailed instructions for use and safety information
(including information on bleeding, exposed vessels and organs
and infection) applicable to your V.A.C.® Therapy Unit and the
dressing applications instructions that can be found with the,
disposable carton or in the V.A.C.® Therapy Clinical Guidelines
booklet available standard in the V.A.C.® Therapy Unit pack.
Step 2 - Cut the appropriate dressing to size
Step 3 - Place dressing in the wound
Do not cut the dressing over the wound as this could
result in foam particles falling into the wound. Gently
rub the cut edges to remove any loose pieces.
Note the total number of pieces of foam used in the
wound.
Step 4 - Trim the drape to size
Step 5 - SensaT.R.A.C.TM Pad Application
Step 6 - Pinch the drape and cut a 2.5cm
round hole
Peel back one side of Layer 1 and place the adhesive
side down over wound. Remove the remaining side of
Layer 1, the green striped stabilisation Layer 2 and the
perforated Blue Handling Tab(s).
Identify application site for the SensaT.R.A.C.TM Pad
Consider the diameter of a 10p piece for size reference.
Step 7 - Remove backing Layers 1 and 2
from the SensaT.R.A.C.™ Pad
Step 8 - Place the SensaT.R.A.C.™ Pad
opening directly over the hole
Step 9 - Connect the SensaT.R.A.C.TM Pad
tubing to the canister tubing
Pull the blue tab to remove stabilisation layer. Record
the date and number of foam pieces in the wound on
the drape and in the patient record.
Step 10 - Switch on the V.A.C.® Therapy Unit
Set to the clinician prescribed therapy settings to initiate
therapy.
™
12
Why do skin grafts fail?
Recognised causes of skin grafts failure include:
Haematoma:
clot formation under
graft
The commonest cause of graft failure is due to the separation of
the graft from the recipient bed, preventing revascularisation.
Inadequate
Wound bed
Poorly vascularised wound beds or the presence of excess
devitalised tissue or slough.
Infection
Bacterial infection can cause the breakdown in the adherent fibrin
layer of the graft.
Seroma
Fluid collection - has a similar effect on graft as haematoma
Excessive pressure
Pressures in excess of the capillary filling pressure may cause graft
necrosis.
Shear forces
Movement resulting from inadequate securing of the graft.
Technical
Covers a number of possibilities (e.g. placing graft upside down,
harvesting a graft of inadequate thickness, etc…)
Patient Factors
Patient factors such as patient being immunocompromised,
suffering from chronic disease (e.g. diabetes), anaemic,
malnourished, has local malignancy which can negatively
contribute to the success of a skin graft
References: MC Swan & PE Banwell, Editors.
Skin Grafting: The Role of Topical Negative Pressure
(TNP) Therapy. Oxford Wound Healing Society
V.A.C.® Therapy and Skin Graft Fixation
V.A.C.® Therapy in addition to wound healing can also be utilized for securing
skin grafts. In particular the foam under negative pressure (the “Crinkled” effect)
acts as an excellent splint in its compressed form. Furthermore, the foam dressing
is also able to conform to various contour defects, making the therapy extremely
useful for difficult anatomical areas. For instance, clinical difficulties commonly
arise in the contoured areas such as the natal cleft, axillary or inguinal region
which are both difficult to dress and prone to shear forces. An additional, yet
crucial, benefit is that the suction force is also able to actively remove the subgraft tissue fluids.This is facilitated if the graft has been meshed or fenestrated
and therefore minimizes the complications inherent in more traditional forms of
skin grafting fixation. If GranuFoam is used on grafts it requires an interface layer
over the graft. WhiteFoam can be be used directly on the graft.
Schematic diagram demonstrating the securing of a
STSG with a TNP dressing
Dedicated dressings for skin graft applications
V.A.C.® WhiteFoam Dressings
Two dressings sizes to choose from depending on wound.
Main Benefits:
•Physicalcharacteristicshelpminimizetissuein-growth
•HighertensilestrengththanGranuFoammakesiteasier
to handle when placing and removing from tunnels and
smaller spaces
•Non-adherent
V.A.C.® WhiteFoam Dressings
are made of a micro-porous,
polyvinyl alcohol (PVA) material
13
CASE STUDIES
The evidence for V.A.C.® Therapy
Negative Pressure Wound Therapy
Case Reports: Chronic wounds
“Since its introduction in the 1990s, it (V.A.C.® Therapy) has
unquestionably saved the limbs and lives of many patients.1”
Keith Harding, 2008. Head of the Department of Wound Healing,
School of Medicine, Cardiff University.
1. A 64 year-old diabetic male following partial forefoot amputation.1
Day 2
Day 10
Day 34
Post V.A.C.
Conclusion
13 days after amputation
and after 2 days V.A.C.®
Therapy 90% granulation
tissue was obtained.
After 10 days of V.A.C.®
Therapy the medial and lateral
wound edges were seen
to be advancing.
After 34 days of V.A.C.®
Therapy the change in wound
dimension was significant.
V.A.C.® Therapy was stopped
after 59 days. 2 weeks later a
continued wound size
reduction was seen.
At four months post surgery
the wound was healed.
The long-term goal of limb salvage was achieved.
2. A 70 year old female patient suffering from a non-healing, combined venous/arterial leg ulcer.
Day 0
Day 5
Day 8
Day 5 post graft
Day 29
V.A.C.® Therapy initiated.
Significant increase in
granulation tissue formation.
Wound dimensions decreasing.
5 days post graft.
Full wound closure.
Following a graft, full wound closure was achieved after 30 days.
“Faster healing, as well as odour and exudate management,
are important aspects of wound care.1”
David Gray, Fiona Russell and John Timmons, 2008.
Department of Tissue Viability, Grampian Health Services, Scotland.
14
Case Reports: Acute wounds
1. A 55-year-old woman with necrotising fasciitis requiring radical surgical debridement.1
Day 0
Day 0
Day 24
Day 60
Day 60
Initiation of V.A.C.® Therapy
after radical surgical
debridement of abdominal
wound.
How V.A.C.® Therapy
was applied.
The patient was discharged
home on the V.A.C.® Freedom
unit after a 72% reduction
in wound size.
V.A.C.® Therapy was
discontinued. 98% of skin
graft was taken successfully.
Wound size continued to
decrease.
V.A.C.® Therapy efficiently managed large volumes of exudate and accelerated the healing
time of this complex wound.
2. A 66 year-old female presenting a dehisced laparotomy wound.1
Day 0
Day 0
Day 5
Day 21
Day 43
Initial assessment of the
wound.
Start application of V.A.C.®
Therapy.
Improving wound
characteristics.
Wound size continued
to decrease.
Patient evaluated
for grafting.
With this large abdominal wound, V.A.C.® Therapy managed wound exudate while facilitating
wound healing. Note: Ensure vital structures such as exposed tendons, ligaments, blood vessels, anastomotic sites, organs and
nerves are adequately protected with overlaying fascia, tissue or other protective barriers prior to the applications of V.A.C.® Therapy.
Case Reports: Trauma wounds
1. A 91-year-old female with a haematoma to the lower leg secondary to a fall.1
At presentation
Day 0
Day 0
Day 2
Conclusion
Wound after removal of
hard necrotic tissue.
After complete debridement a
significant undermining
was revealed.
The undermined area
was filled with V.A.C.®
GranuFoam®
After 48 hours the
undermined area had
decreased in size.
After 8 days inpatient and 14
days care at home undermining
was eliminated and granulation
tissue was level with wound
margin.
V.A.C.® Therapy was used to promote rapid growth of granulation tissue in a patient with a
number of comorbidities who was at risk of delayed healing.
References 1. Gray, D. Russell, F. Timmons, J: Editors. VAC Therapy: An introduction and practical guide. Wounds UK, 2009. 2. KCI Times, Germany. 2008 (2) - Internal data on file.
15
KCI Medical India Private Limited - Kinetic Concepts
Inc (KCI)USA started operations in India through
its 100% subsidiary M/s KCI Medical India Private
Limited in September 2010 with the Advanced
Wound Care Management product portfolio of Active
Healing Solutions. KCI provides the sales, service and
clinical support to its customers through its exclusive
distributor M/s Labindia Healthcare Pvt. Ltd and
through their channel partners. We have a full fledged
sales, service, quality control/assurance and clinical
support team operating out of major cities to provide
24/7 support.
Over 2000 Patients with serious acute and chronic
Wounds have been treated with the V.A.C.® Therapy
Units (Negative Pressure Wound Therapy) and
proprietary GranuFoam™ Dressings since launch in
India.
With the growing incidence of chronic wounds in the
country such as diabetic foot ulcer, pressure ulcer and
acute wounds, we are quite confident of addressing
the needs of healthcare providers.We will be soon
launching a series of new products ActiV.A.C.®
Negative Pressure Wound Therapy System, Prevena™
Incision Management System and ABThera™ Open
Abdomen Negative Pressure Therapy System in the
AHS Product Line, and the mattress replacement
systems, and critical care/ bariatric care beds in future.
KCI is committed to advancing healing technology that
positively affects the lives of patients, their families,
caregivers and healthcare professionals alike.
We believe that all patients deserve the most advanced
treatments available to heal wounds and improve lives
whilst still lowering treatment costs.
30 years ago, a handful of visionary technocrats sowed
the seed of the philosophy of an organization called
Labindia.
Labindia was founded in 1981 and promoted by a group
of committed and visionary technocrats, engineers and
professionals. The founders have since grown Labindia
into a highly successful sales, marketing, service and
support organization that is recognized all over India
as a key supplier of products for Healthcare solutions
in Advanced Wound Management, Critical Care,
Diagnostics, Medical Imaging, Sleep Sciences and Rural
Pharmacy.
As the common man in India strives for the world class
medical technologies, Labindia Healthcare pledged to
bring revolutionary devices and technologies to India.
Today Labindia aims for leaving an impact in the world
of medical technologies. With credential soaring high as
ever, Labindia continues to set its unique benchmarks in
this industry.
30
years of establishment
800
Plus skilled professionals
24x7
20
customer support &
inhouse clinical support
offices
KCI Connect newsletter is Published by KCI Medical India Pvt. Ltd.,
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© 2011 KCI Licensing, Inc. All rights reserved. The copyright, any and all trademarks and trade names and other
intellectual property rights subsisting in or used in connection with and related to this publication are, unless another
owner is specified, the property of KCI Licensing, Inc. No part of this publication may be reproduced, stored in a retrieval
system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, with
out the prior written permission of KCI Licensing, Inc. DSL#11-0594.IN.1.1 (9/2011)
For information on our products and solutions,
visit the company’s Web site at www.kci-medical.in
or email us at [email protected]
Local regulations affect product availability. Therefore, the products discussed on this publication may not be for sale of
promotion in all countries.
DISCLAIMER AND LIMITATION OF LIABILITY
Whilst KCI Medical endeavors to provide on this publication accurate information, the articles may contain incomplete
information, the information may contain errors or the information may be outdated.
No representation of warranty of any kind, either express or implied, is or has been made as to the completeness,
accuracy or reliability of the information in this publication or to the information or material of the third parties that may
be published in this publication.
Further the reader expressly acknowledges that the usage of reliance on the information contained in this publication is
at the reader’s own risk.
KCI Medical shall not under any circumstances be liable for any direct, consequential, incidental, secondary or special
damages or lost profits resulting from this publication or its contents.
Views and Opinions expressed in this publication are independent views of the writers/commentators and are not
necessarily those of the magazine and accordingly no liability is imputable to KCI Medical. Please note that the views and
opinions stated in this publication are NOT medical advise.