Table of Contents

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Table of Contents

• Overview
• Method of Action
• Product Overview
• Applying the DermaClose
• Clinical Applications
• Publications

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Overview

• The DermaClose RC Continuous External Tissue
  Expander is an innovative device used to expand
  tissue adjacent to a wound.
• Once set, the unique DermaClose RC tension
  controller applies a constant pulling force of
  1.2 kg that does not require additional
  tightening after initial application. This
  capability means that constant tension is applied
  to the tissue adjacent to the wound resulting in
  controlled tissue expansion.
• DermaClose RC is extremely versatile and has a
  broad application across a range of specialties.
• Depending on wound size and location, it is
  possible for significant expansion to occur
  intraoperatively. For many wounds it may take a
  few days to obtain maximum results.
• Once adequate expansion is accomplished the
  DermaClose RC is removed and the wound is either
  sutured closed or the smaller wound is allowed to
  heal by secondary intention or alternative
  interventions.

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Overview

• Can be used to reduce the size of a wound
  intraoperatively.
• Delayed primary closure.
• Can act as a bolster to reduce amount of tension
  on suture line.

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Method of Action
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Method of Action

• Elastin Collagen in tight bundles within Dermis
  surrounding the wound

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Method of Action

• Tension applied by skin anchors realigns the
  Collagen and Elastin fibers longitudinally
• Stress Relaxation of Collagen and Elastin
• Fibers remain elongated after tension in removed

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Product Overview
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Product Overview

• DermaClose RC
• Product Components
• Product Overview
• DermaClosable Wounds
• Benefits

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DermaClose RC Components
Skin Anchors
Tension Controller
Tygon Bridge Tubing
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DermaClose RC Components
Tension Control Loop
Tension Controller
Lock Button
Tension Control Knob
Tygon Bridge Tubing
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DermaClose RC Components
Tension Line Tab
Skin Anchor
Skin Engagement Barb
Skin Staple Locations
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DermaClosable Cases
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DermaClose RC Pricing
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DermaClose Benefits

• Safe and Effective
• Easy to apply and remove
• No need to readjust or retighten, once set
• Controlled and constant pulling force
• Has been shown to facilitate 86 wound area
  reduction in an average of three days
• Can be used on multiple wound shapes and sizes

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DermaClose Application
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DermaClose Application

• Before Application
• Before Applying DermaClose to a wound please
  ensure that the following steps have been taken
  
• Tissue Surrounding the Wound is healthy
• Avoid the following
• Macerated Skin
• Avascular Tissue or poor perfusion
• Flaky/Brittle Tissue
• Necrotic Tissue
• Infected Tissue Or tissue that may be at risk of
  infection

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DermaClose Application

• Before Application
• Before Applying DermaClose to a wound please
  ensure that the following steps have been taken
  
• Wound is Free of Infection
• Thoroughly Debride the Wound
• Tidy up Wound Margins
• If appropriate, you may wish to consider making
  wound elliptical

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DermaClose Application

• Before Application
• Before applying DermaClose to a wound please
  ensure that the following steps have been taken
  
• Wound Edges are Surgically Undermined
• In many cases undermining at least 2cm from wound
  edges in order to mobilize the dermis on the
  subcutaneous plane may be helpful

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DermaClose Application

• Step One
• Insert Skin Anchors into the Skin
• 1cm 3cm from the wound edge.
• It may be easier to pre-mark the locations with a
  marker

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DermaClose Application

• Step Two
• Secure Anchor with Two Staples
• The enclosed 3M Skin Stapler has a two stage
  mechanism. This allows you to position the staple
  and then squeeze fully to apply the staple across
  the skin anchor and into the skin.

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DermaClose Application

• Step Two
• Secure Anchor with Two Staples

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DermaClose Application

• Step Three
• Skin Anchors should be placed 2 to 3 cm apart

2cm 3cm
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DermaClose Application

• Step Four
• Press Tension control knob down and pull the line
  out

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DermaClose Application

• Step Five
• Decide on Position of Tension Controller
  Relative to the Wound

Remotely
Locally
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DermaClose Application

• Step Five
• If Tension Controller is to be placed Remotely
• Thread Tension Line into Bridge Tubing as
  Necessary

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DermaClose Application

• Step Six
• Seat Tension Controller on Home Anchor
• Often at the widest part of the wound

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DermaClose Application

• Step Seven
• Thread Tension Line under tab of off-set skin
  anchors moving from inside to outside of the
  anchors

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DermaClose Application

• Step Eight
• Thread Line around the outside and then back
  under the tab of the opposing anchors

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DermaClose Application

• Step Nine
• Thread line back inside to the middle tab
  opposing the Home Anchor

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DermaClose Application

• Step Ten
• Check Line Symmetry and ensure that there are no
  eyelets around the anchors

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DermaClose Application

• Step Eleven
• Turn Tension Control Knob Clockwise to Tighten
• After about ten full rotations an audible
  clicking will eventually be heard indicating that
  the pre-determined tension of 1.2kg has been
  reached

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DermaClose Application

• Step Twelve
• Engage Lock Button
• Dress Wound as Appropriate

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Clinical Application
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Clinical Application

• Plastic Reconstructive Surgery
• Vascular Surgery
• General Surgery
• Foot Ankle Surgery
• Dermatology

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Plastic Reconstructive Surgery

• Fasciotomy Leg Crush Injury (Page 1 of 2)

Intra-Operative
Before Application
Patient sustained a crush injury to the lower
leg. Compartment Syndrome resulted in a four
compartment fasciotomy
Post Application of the DermaClose with immediate
reduction in wound size
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Plastic Reconstructive Surgery

• Fasciotomy Leg Crush Injury (Page 2 of 2)

Day 4
Day 4
Patient returned for final wound closure on Day
4.
The wound was successfully closed with skin glue,
retention sutures and steri-strips
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Plastic Reconstructive Surgery

• Fasciotomy Gunshot Wound (Page 1 of 2)

Intra-Operative
Before Application
Patient 31yr old male sustained a gun-shot wound
to left popliteal fossa. Further examination
revealed that the patient had no palpable pulse
in the left foot and required a vein graft. A
four compartment fasciotomy was performed.
After 48hrs Patient was moved to OR for closure
of the fasciotomy sites. The medial was closed
primarily but there was too much tension to close
the lateral fasciotomy. A DermaClose RC was
used with a shoelace technique.
Images Courtesy of AB Levitt MD
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Plastic Reconstructive Surgery

• Fasciotomy Gunshot Wound (Page 2 of 2)

Day 3
Day 3
The patient had no complaints of pain with the
device in place. The wound was closed using a
2-0 monofilament non-absorbable and the
DermaClose RC device was removed.
After three days, the patient returned to the OR
and the dressings were removed. The tissue
adjacent to the fasciotomy wound had expanded
significantly and the wound edges had
approximated.
Images Courtesy of AB Levitt MD
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Plastic Reconstructive Surgery

• Fasciotomy Compartment Syndrome - Leg (Page 1
  of 3)

Day 1 Left Medial Leg
Day 1
19 x 5.5 cm
Day 1 Right Medial Leg
16 x 5 cm
Patient 17yr old student suffered a cardiac
arrest. Due to ischemia reperfusion injury he
developed a bi-lateral lower extremity
compartment syndrome with muscle necrosis. He
underwent serial debridement for 8 weeks before
closure could be attempted.
The DermaClose RC Continuous External Tissue
Expander (CETE) skin anchors were applied to the
wound edges, approximately 2-3 cm apart and
secured with skin staples.
Images Courtesy of B Carlsen MD, Dept. of
Plastic Surgery. Mayo Clinic, Rochester MN
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Plastic Reconstructive Surgery

• Fasciotomy Compartment Syndrome - Leg (Page 2
  of 3)

Day 6 Left Medial Leg
Day 1 Left Medial Leg
Day 1
10.5 x 2 cm
Day 6 Right Medial Leg
Day 1 Right Medial Leg
13 x 2.5 cm
The distal and proximal aspect of the wounds were
approximated and closed using sutures. The
DermaClose Tension Controller was applied to each
wound. Significant reduction in the wound area
was achieved intra-operatively.
After 6 Days the patient returned, the wound
edges had approximated and the DermaClose devices
were removed.
Images Courtesy of B Carlsen MD, Dept. of
Plastic Surgery. Mayo Clinic, Rochester MN
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Plastic Reconstructive Surgery

• Fasciotomy Compartment Syndrome - Leg (Page 3
  of 3)

Day 1
The Bilateral Leg wounds were closed primarily
resulting in minimal amount of scarring due to
closure at the original incision line.
Images Courtesy of B Carlsen MD, Dept. of
Plastic Surgery. Mayo Clinic, Rochester MN
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Plastic Reconstructive Surgery

• Fasciotomy Compartment Syndrome - Arm (Page
  1 of 3)

Day 1
Day 6 Left Medial Leg
Day 1 Left Medial Leg
Day 1
Day 1
Left Dorsal Forearm
Day 1 Right Medial Leg
Day 1
Right Dorsal Forearm
Left Dorsal Forearm
Right Dorsal Forearm
The patient, a 44 yr old male underwent a
cervical laminectomy and foraminotomy fusion.
The procedure was complicated by bilateral
extensor compartment syndrome which required
urgent Fasciotomy.
The DermaClose CETE Device was applied to the
fasciotomy wound in conjunction with NPWT.
Images Courtesy of B Carlsen MD, Dept. of
Plastic Surgery. Mayo Clinic, Rochester MN
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Plastic Reconstructive Surgery

• Fasciotomy Compartment Syndrome - Arm (Page
  2 of 3)

Day 1
Day 1 Left Medial Leg
Day 1
Day 1
Left Dorsal Forearm
Right Dorsal Forearm
Right Dorsal Forearm
Left Dorsal Forearm
Right Dorsal Forearm
DermaClose CETE worked in conjunction with NPWT .
DermaClose was able to expand the tissue
adjacent to the wound without compromising the
function of the NPWT
Images Courtesy of B Carlsen MD, Dept. of
Plastic Surgery. Mayo Clinic, Rochester MN
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Plastic Reconstructive Surgery

• Fasciotomy Compartment Syndrome - Arm (Page
  3 of 3)

Month 3 Left Dorsal Forearm
Day 4 Left Dorsal Forearm
Day 1
Day 6 Left Medial Leg
Month 3 Right Dorsal Forearm
Day 7 Right Dorsal Forearm
Left Dorsal Forearm
Day 1
Left Forearm On day four both the NPWT and the
DermaClose device were removed and the wound was
closed by delayed primary intention Right Forearm
Day seven both the NPWT and the DermaClose were
removed. A small area required STSG whilst the
majority of the wound was closed by delayed
primary closure.
Three Month Follow Up Left Forearm Wound
Completely Healed Right Forearm Small wound
remains as a result of poor graft take.
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Tissue Loss Injury
Photos courtesy of Dr. Wadih Macksoud MD,
Orthopedic Surgeon, Orlando, FL
R Leg
R Leg
Day 1
Day 4
14 y/o patient suffered injuries including
amputation of left leg as a result of a boating
accident. DermaClose was used for just seven
days to approximate the margins and facilitate
closure of his right leg.
R Leg
Day 7
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Clinical Application

• Plastic Reconstructive Surgery
• General Surgery
• Podiatry
• Wound Care
• Dermatology

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General Surgery

• Abdominal Case (Page 1 of 3)

28 x 23 cm
10 x 22 cm
6 x 18 cm
Before Application
Day 1 Pre Op
Day 1 Post Op
48 hr Post Op
36yr old morbidly obese diabetic patient
presented with incisional hernia in 2008 and was
treated with a succession of mesh products that
eventually became infected.
NPWT was applied for 2 months prior to applying
the DermaClose CETE device. Two devices were
applied in a procedure lasting 1 hour. The
patient returned after 48 hrs
Images Courtesy of H L Tuten MD, Dept. of
Surgery. New Iberia LA
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General Surgery

• Abdominal Case (Page 2 of 3)

3 x 6 cm
Before Application
48 hr Post Op Reapplication
5 Days Post Op
5 Days Post Op Reapplication
At 48 hrs the wound was irrigated and the two
DermaClose CETE devices were reapplied.
Additional sutures were placed on the lateral
edges.
The dressing was removed 36 hours later and a
single DermaClose device was applied to the much
smaller wound.
Images Courtesy of H L Tuten MD, Dept. of
Surgery. New Iberia LA
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General Surgery

• Abdominal Case (Page 1 of 3)

Before Application
Day Nine
Day Nine Closure
Four Month Follow-Up
After a further four days the patient returned to
the OR. It was possible to approximate the wound
edges and suture closed.
Four month follow up, a small wound of unknown
origin had formed below the closed wound.
Images Courtesy of H L Tuten MD, Dept. of
Surgery. New Iberia LA
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Neil Lavaas M.D.
Dehisced abdominoplasty non-healing for two
months
Day 1
DermaClose RC used to assist in closing 14 x 8 cm
dehisced abdominoplasty inter-operatively. The
DermaClose was left in place for 72 hours after
suturing the wound closed to minimize tension on
sutures.
14 x 8 cm wound
Day 1
Day 1
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Clinical Application

• Plastic Reconstructive Surgery
• General Surgery
• Foot Ankle Surgery
• Dermatology

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David Armstrong D.P.M., PhD.
Second partial metatarsal resection and digital
amputation
After two months V.A.C. therapy failed to close
the wound
7 days after application
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David Armstrong D.P.M., PhD.
DermaClose instrumental in limb salvage case
Three weeks post DermaClose RC application
A separate device was used on the plantar surface
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Charles Hastings D.P.M.
2 years non-healing plantar wound
55 Y/O Male diabetic patient injured post
hurricane Katrina when he stepped on a nail
developed a serious infection
had the wound for more than two years edges were
freshened and DermaClose placed on 5/12/08
Patient return seven days later on 5/19/08 the
wound was fully approximated
After being open for two years the wound was
closed in 7days
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Dr. Jason Hanft D.P.M. Case 1
Pre-op photo of Achilles wound after 2 months
wound management by Dr. Hanft. The wound was
open for more than a year.
Photo 15 minutes after application of the
DermaClose. The device was left in place for 24
hours.
One week post application of the DermaClose.
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Alexander M. Reyzelman DPMAssistant Professor,
Chair Department of Medicine California School of
Podiatric Medicine, Samuel Merritt College
Non-healing partial 1st ray amputation wound
Chronic post-amputation defect
24 hrs later
Seven week follow-up
Patient is a 58-year-old male with diabetes
mellitus who on 12/01/07 underwent partial first
ray amputation that was left open. This was
performed due to osteomyelitis of the first
metatarsal. He was getting wet-to-dry dressing
changes on daily basis along with local wound
care. After extensive surgical debridement the
wound measured 4.0 x 2.5 cm x 1.5 cm deep. On
02/07/08, a DermaClose tissue expander device was
applied to his skin to help facilitate closure.
The patient returned 24 hours after placement of
the device for delayed primary closure with 3-0
Prolene suture. Following the delayed primary
closure, Unna boot and Coban compression dressing
were applied which he has been getting twice a
week. On 02/21/08, sutures were removed and
Coban, Unna boot were applied again. Patient has
not had any complications and still has a small
opening of the proximal portion of the wound
which is completely granular in nature with no
probing to bone and no exposed bone. He is
currently one month status post delayed primary
closure and his wound is progressing well
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DermaClose / V.A.C.
John S. Steinberg, DPM FACFASAssistant
Professor, Department of Plastic
SurgeryGeorgetown University School of Medicine
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Radial Technique
Photos courtesy of Mark Freidman D.P.M.
Before application
Approximate 30 reduction following application
3.5 cm x 2.5 cm
Immediately following application
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Wound Reduction
Photos courtesy of Wilburn E. Thomas D.P.M.
2/20/08
3/5/08

• Wound reduction case approximately 40
• Extra-cellular matrix to be applied post
  DermaClose

3/7/08
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Alexander M. Reyzelman DPMAssistant Professor,
Chair Department of Medicine California School of
Podiatric Medicine, Samuel Merritt College
Non-healing partial 5th ray amputation wound
Patient is a 60-year-old female with diabetes
mellitus. On 12/31/07, patient underwent fifth
ray amputation due to osteomyelitis on fifth
metatarsal. She previously underwent a
below-the-knee amputation of the left over two
years ago. She recently sustained an ulcer on the
right lateral fifth metatarsophalangeal joint
which developed an osteomyelitis and therefore
partial fifth ray amputation was performed
12/31/07. She underwent weekly local wound care,
debridement in the office, and wet-to-dry
dressing changes. On 01/14/08, patient had the
DermaClose device applied for tissue expansion,
it was left on for one hour and then delayed
primary closure was performed in the office using
4-0 Prolene. She was completely healed with full
epithelialization on 2/28/2008. There were no
complications with the procedure..
Day 1
Day 1
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Mary Barna D.P.M.
Chronic venous leg ulcer closed in 48 hours
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Mary Barna D.P.M.
September 18, 2007 - A 57 year old female
presented with a history of right lower extremity
abscess. The wound was surgically treated
successfully but left an open wound 28 cm x 10 cm
x 3.0 cm. She was placed on the KCI Wound VAC
and was subsequently closed with the DermaClose
RC continuous external tissue expander. Two
devices were used because of the large size of
the wound. A reduction of 66.7 was achieved in
48 hours. At which time a large section of the
wound was sutured closed with 4-0 Nylon.
Approximately 10 cm in at the central area will
be closed in the near future with another
application of the external tissue expander.
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Clinical Application

• Plastic Reconstructive Surgery
• General Surgery
• Foot Ankle Surgery
• Dermatology

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Large Squamous Cell Carcinoma
Jane Lisko M.D.
5.3 x 4.4 cm defect
Day 1
Day 1
2 x 1.5 cm
Eight week follow-up
24 hours later
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Veronique Blatiere M.D.
Dermafibromasarcoma Protuberans
8 x 6 cm wound
Closure inside line loop reduced tension on
sutures
Inter-operative use of the device
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Jeffery N. Samuelson M.D.
Atypical fibroxanthoma of the vertex scalp
Day 1
Day 1
3 x 3 cm defect
Post-application
Day 14
Day 2
5.25 cm scar
Approximated margins
Two week follow-up
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Amir A. Bajoghli M.D.
Courtesy of Amir A. Bajoghli, MD Mohs
Surgeon, George Washington University
Trichilemmal cystic carcinoma (wound reduction
case)
6.3 X 5.8 cm defect post-op
C.L.H. 65 year old male underwent Mohs
micrographic surgery which cleared the tumor in 3
stages. The DermaClose was left in place 24
hours. The resulting 1.0 x 3.0 cm healed nicely
by secondary intention.
Eight week follow-up
Two week follow-up
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Publications
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Foot Ankle Surgery

• Hanft et al
• Foot and Ankle Institute, Doctors Research
  Network, South Miami, FL
• DFCon 2009 SAWC 2009 NAPMA 2009
• 25 Patient Study
• 86.9 Wound Area Reduction after 3 Days
• Total 674.3 cm2 of total tissue expansion across
  25 patients in three days

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Amount of DermaClose RC Tissue Expansion
cm2 Jason R. Hanft DPM, FACFAS, et,al, Foot and
Ankle Institute, Doctors Research Network, South
Miami, FL
Patients
A recent twenty-five patient case series resulted
in 674.3 cm2 of total tissue expansion in the
lower extremity in an average of 3 days.
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Plastic Reconstructive Surgery

• Carlsen et al
• Dept of Plastic Surgery, Mayo Clinic Rochester
  MN
• Wound Healing Society 2010
• 2 Patient Experience
• Fasciotomy Closure

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Dermatology

• A. A. Bajoghli et al
• Dept. of Dermatology, George Washington
  University School of Medicine
• Journal of Drugs in Dermatology
• Vol 9 Issue 2
• Case Experience
• DermaClose is a viable alternative to Skin Graft
  in the closure of Mohs Surgery Wounds

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Foot Ankle Surgery

• Reyzelman et al
• Bay Area Foot Care, San Francisco
• Podiatry Today
• June 2009
• Case Experience

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Foot Ankle Surgery

• Bevilacqua Rogers
• Valley Presbyterian Hospital, Los Angeles. CA
• Podiatry Management
• February 2010
• DermaClose is an essential tool on the wound
  closing continuum

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