Mike Griffiths1 1AOTI (Oceanside, United States)

1. Mike Griffiths1
1AOTI (Oceanside, United States)

2. Advanced Adjunctive Wound Care Treatment
Modalities such as Negative Pressure Wound
Therapy (NPWT), Full Body Hyperbaric Oxygen
Therapy (HBO) and Topical Wound Oxygen
Therapy (TWO2), are commonly used to help
heal recalcitrant chronic wounds.
This study compares their relative application
and the published evidence as to their
effectiveness and costs

3. A thorough literature review was conducted for each
modality when utilized in the treatment of Diabetic
and Venous ulcers.
Functional and ease of application comparisons
between the modalities, as well as their relative
clinical and cost effectiveness in healing chronic
diabetic and venous ulcers was evaluated

4. Company Confidential 4
Pubmed search* TOTAL: 317 found articles
Literature retrieved for more detailed
Assessment n=82
Literature excluded as
not topical oxygen
n=235
Literature excluded:
Not relevant n=1
Not in English n=3
No human data n=2
Hyperbaric Oxygen n=7
Duplicates n=29
Literature with
relevant clinical
data n=20
Search in
citations of
relevant papers
and reviews for
relevant studies
n=13
Including literature cited
n=33
*Pubmed search with the following algorithms:
topical[All Fields] And "oxygen"[All Fields])And "wound"[All Fields]) n=121
topical[All Fields] And "oxygen"[All Fields])And "ulcer*"[All Fields]) n=69
topical[All Fields] And "oxygen"[All Fields])And "diabetic"[All Fields]) n=41
topical[All Fields] And "oxygen"[All Fields])And "venous"[All Fields]) n=38
topical[All Fields] And "oxygen"[All Fields])And "burn"[All Fields]) n=31
topical[All Fields] And "oxygen"[All Fields])And "graft*"[All Fields]) n=17

5. Author Published Journal Patients
(Treatment/
Control)
Outcome
(Complete Healing Rates)
Aburto 2010 (Oral
Presentation
and published
abstract)
International
Diabetic Foot
Congress
20/20 Diabetic: 90% vs. 40% healed in 12 weeks
Venous: 50% vs. 30% healed in 12 weeks
Blackman 2010 OWM 17/11 82% vs. 45% healed (12 wks)
Nie 2010 Journal of
Reparative and
Reconstructive
Surgery
23/18
(Total 85)
Burns: Wound healing rates 85% vs. 68%
Sultan 2010 American Society
for Vascular
Surgery
46/37 3 year follow up. 80% vs. 14% remained
healed at 36 month
Tawfick 2009 European Journal
for Vascular
Surgery
46/37 80% vs. 35% healed (12 wks)
Heng 2000 OWM 13/27 90% vs. 22% healing (16 weeks)

6.  Leslie, 1988
Author Published Randomized Patients
(Treatment/
Control)
Outcome
Doctor 1992 YES 15/15 No data on wound healing
13% vs. 58% amputation (no time
given)
Faglia 1996 YES 35/33 No data on wound healing
8.6% vs. 33% amputation (7 weeks)
Kessler 2003 YES 15/13 14% vs. 0% healing after 3 weeks
Abidia 2003 YES 9/8 • 62.5% vs. 12.5% healing at 6 wks
• 62.5% vs. 25% at 6 month
Duszun 2008 YES 50/50 No data on healing; 3 year follow up
8% vs. 48% amputation
Löndahl 2010 YES 48/42 • No Difference after 12 wks (12% vs.
2% healing)
• No difference after 6 month,
• After 12 month 52% vs. 29% healing

7. TWO2
Heng, 2000
16 wks
n=40
TWO2
Blackman, 2010
12 wks
n=27
TWO2
Aburto, 2010
12 wks
n=20
HBO
Abidia, 2003
1 year
n=17
HBO
Löhndahl, 2010
1 year
n=90
Healed in
Oxygen group
90 82 90 62.5 52
Healed Controls 22 45 10 25 29
0
10
20
30
40
50
60
70
80
90
100
Pecentigeofhealing
Healing rates in Diabetic ulcers

8. TWO2
Tawfick; 2009
12 wks
n=83
TWO2
Aburto, 2010
12 wks
n=20
HBO
Hammarlund, 1998
18 wks
n=16
Healed in
Oxygen group
80 50 25
Healed Controls 35 30 0
0
10
20
30
40
50
60
70
80
90
Percentigeofhealing
Healing rates in Venous ulcers

9. Author Published Randomized Patients
(Treatment/
Control)
Outcome
McCallon 2000 NO 5/5 Mean time to satisfactory healing 22.8
vs. 42.8 days
Armstrong 2005 YES 77/85 Healing in post-amputation wounds
56% vs. 39% in 16 weeks
Blume 2008 YES 169/166 43.2% vs. 28.9% healing in 16 weeks
Vuerstaek 2006 YES 30/30
Venous only:
13/13
• All patients received skin grafting
• After 43 days 90% vs. 48% healed
• 40% adverse events to compared
to 23% in control group
• Reoccurrence rate 52% in VAC vs.
42% in controls after one year
*The study from Eginton, 2003 was not considered as only 6
patients completed the trial

10. TWO2
Heng, 2000
16 wks
n=40
TWO2
Blackman, 2010
12 wks
n=27
TWO2
Aburto, 2010
12 wks
n=20
NPT
Armstrong, 2005
16 wks
n=162
NPT
Blume, 2008
16 wks
n=335
Healed in
Oxygen group
90 82 90 56 43.2
Healed Controls 22 45 10 39 28.9
0
10
20
30
40
50
60
70
80
90
100
Percentigeofhealing
Healing rates in Diabetic foot ulcers

11. HBO TWO2 NPWT
Institutional Use only Virtually everywhere
Virtually everywhere
(FDA warning in non acute sites)
Requires specialized facilities
and personal
Only basic training needed
Well trained personal
needed
Systemically oxygenates
blood at 2,500 mb
Topical oxygenation of
wound tissue at 50 mb
Applies a Vacuum
at 75-125 mmHg
Relies on vascular system to
deliver O2
Delivers O2 directly to
superficial tissue even when
severed from circulation
Does not directly
address O2 supply to
wound
Risk of multi-organ toxicity
multiple contraindications
No risks reported
Tremendous pain decrease
in venous patients
A number of deaths
reported due to bleeding
in homecare settings

12. HBO TWO2 NPWT
Daily travel to facility for
90 min treatment
60 - 90 min treatment
at home
Continuous treatment
at home 24/7
Advanced dressings used in
normal manner
Oxygen permeable
dressings recommended
Commonly applied with
dedicated dressing
Relatively well studied Relatively well studied Well studied
Mechanism of action logical
but with systemic risks
Mechanism of action logical
and most “biological”
Mechanisms of action
logical with some risks
Heals wounds completely Heals wounds completely
Supports building of
granulation tissue
Expensive Relatively Inexpensive Relatively Inexpensive

13. As has been pointed out in many published reviews, the quantity and
quality of Randomized Controlled Studies for each of the modalities is
limited. This being said, the entire body of published evidence for all
three modalities is significant, allowing for meaningful comparisons.
With the ever increasing global incidence and resultant costs
associated with treating chronic diabetic and venous ulcers, it is
critical that both the clinical effectiveness and cost effectiveness of
different modalities be considered when making treatment decisions.
Both HBO and TWO2 appear more effective than NPWT in healing
chronic Diabetic ulcers. TWOT appears more effective than both HBO
and NPWT in healing chronic Venous ulcers. NPWT and TWO2 offer
the additional benefit of being deliverable in non-institutional settings
where healthcare delivery costs are lower and thereby would likely be
more cost effective.