Key Clinical Factors
• Perfusion
– Anti-inflammatory Fish Oil
• Vasodilator
• Biofilm
– Oil creates Acid Mantle in Wound Bed
• Binds calcium needed for biofilm structure building
• Off-loading
– Clinician Time Saving
• Creates time for proper off-loading
4
Model Development
TEACH FORMULATE CLINICAL OBSERVATIONS
MODEL REVISION
5
Invention Focus
US PTO MENTIONS (2001 to 2009)
Chronic Wound 364
Periwound 61
Chronic Wound + Periwound 6
6
Evidence-Based Practice
• Current Paradigm
– Optimize the Variable
• Single-Variable Significant Difference
• Proposed Paradigm
– Optimize the System
• Wound Bed
• Wound Margin
• Lower Leg
• Patient Compliance
7
Fish Oil Collagen Paste +
Collagen Matrix
• Anhydrous
• Slow-release oil
– Fish Oil
• EPA C20:5n3
• DHA C22:6n3
– Red Palm Oil
• Antioxidants
• Vitamins
– All 8 moieties of Vit. E
• Wound bed moisture
control
• Wound margin protection
Red Palm Oil Salmon Oil
• Control leakage
8
Omega 3 Fatty Acid
• Count from the tail
• EPA C20:5n3
• DHA C22:6n3
9
Collagen Added
• Fish oil + collagen increased the rate of
healing
• Anhydrous
• Messiness resolved by covering with
collagen matrix
10
Mrs. Bell’s Crème
• Improves skin texture on lower leg
• Cosmetic elegance increases compliance
• Increases lower leg circulation
– Omega 3 oil is a vasodilator
• Lymph and venous systems drain faster
11
After Three Weeks of Crème
12
Protocol
1. Debride once
2. Fill wound with Fish Oil Paste
1. Coat the Margin
3. Press collagen matrix into paste
4. Rub entire lower leg with Crème
5. Cover wound with Adaptic
6. Wrap & off-load pressure
7. Repeat weekly
13
Wound Ready for Treatment
14
Beginning to Apply Collagen Paste
15
Paste Applied in Wound Bed
16
Fibracol Covers Paste
17
Adaptic Over Fibracol
18
Fully Wrapped
19
Consistent Clinical Findings
• Less debriding
• No wound bed disruption
• No infection
• No periwound debriding
• Moist, never wet
• Rapid epithelialization
• Little swelling
• Lower leg: Pink & Warm
• No dermatitis
• Happy Patients
20
Start
(2.9cm x 1.8cm = 5.22cm2)
21
After Two Weeks
(2.0cm x 1.7cm = 3.4cm2)
22
After Three Weeks
(1.7cm x 1.4cm = 2.38cm2 )
(54% reduction)
23
Beneficial Synergy
• Simultaneously Treat:
– Wound bed
– Wound margin
– Lower leg
• It’s a system, not a single variable
24
Acknowledgment
• Dr. Randy Wolcott
– It’s the acid mantle, Stupid
• Dr. Marcia Ryder
– Chelating compounds kill biofilms
25
Technical Model
fish oilh
collagen collagen/water gel
& EXUDATE & OIL @ pH = 5.5
oil is adsorbed by collagen collagen swells with water & releases oil
27
Wound Bed Model
28
Margin/Wound Bed Interface
29
Apparent Circulation Increase
• Short chain fats are converted into fatty
acids and esters.
• The acids cause a pH drop similar to the
lactic acid pH drop in muscle activity.
• Bohr-Effect oxygen is dropped locally and
gives the appearance of better circulation
• The omega 3 fats are vasodilators
– The existing lymph and venous systems drain
better.
30
Fatty Acid Packing Density
• C16 & C18 nest
together
• Packing Density =
1+sin 60°=1.707
Wound Bed
32
Calcium Sequestration
+Ca+ +Ca+ +Ca+ +Ca+ • Divalent cations
¯ ¯ ¯ ¯ preferentially bind
¯- ¯- ¯- ¯- to free fatty acid
and are no longer
available for biofilm
stabilization
Wound Bed
33
Apparent Increased Circulation
Figurative Leg
Topical Nutrients
Wound
Omega 3 Vasodilators
Oil-to-Fatty Acid lowers local blood pH,
increasing local oxygen availability
34
Steps to Success
1. Find a willing doctor
2. Listen to patients
3. Photographic evidence
4. Lower natural defense mechanisms
5. Reformulate on anecdotal data
6. Construct technical models
7. Modify model to explain new findings
8. If model is stable, you are close
9. Test product/protocol with others
10. Find a path through the regulatory maze 35
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