Mike Griffiths1
1AOTI (Oceanside, United States)
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
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
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
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)
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
TWO2Heng, 2000
16 wksn=40
TWO2Blackman, 2010
12 wksn=27
TWO2Aburto, 2010
12 wksn=20
HBOAbidia, 2003
1 yearn=17
HBOLöhndahl, 2010
1 yearn=90
Healed inOxygen 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
Pe
ce
nti
ge
of
he
ali
ng
Healing rates in Diabetic ulcers
TWO2Tawfick; 2009
12 wksn=83
TWO2Aburto, 2010
12 wksn=20
HBOHammarlund, 1998
18 wksn=16
Healed inOxygen group
80 50 25
Healed Controls 35 30 0
0
10
20
30
40
50
60
70
80
90
Pe
rce
nti
ge
of
he
ali
ng
Healing rates in Venous ulcers
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
TWO2Heng, 2000
16 wksn=40
TWO2Blackman, 2010
12 wksn=27
TWO2Aburto, 2010
12 wksn=20
NPTArmstrong, 2005
16 wksn=162
NPTBlume, 2008
16 wksn=335
Healed inOxygen 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
Pe
rce
nti
ge
of
he
ali
ng
Healing rates in Diabetic foot ulcers
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
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
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.