Mike Griffiths1
1AOTI (Oceanside, United States)
Advanced Adjunctive Wound Care Treatment
Modalities such as Negative Pressure Wound
Therapy (NPWT), Full Body Hyperbaric O...
A thorough literature review was conducted for each
modality when utilized in the treatment of Diabetic
and Venous ulcers....
Company Confidential 4
Pubmed search* TOTAL: 317 found articles
Literature retrieved for more detailed
Assessment n=82
Lit...
Author Published Journal Patients
(Treatment/
Control)
Outcome
(Complete Healing Rates)
Aburto 2010 (Oral
Presentation
and...
 Leslie, 1988
Author Published Randomized Patients
(Treatment/
Control)
Outcome
Doctor 1992 YES 15/15 No data on wound he...
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...
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...
Author Published Randomized Patients
(Treatment/
Control)
Outcome
McCallon 2000 NO 5/5 Mean time to satisfactory healing 2...
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...
HBO TWO2 NPWT
Institutional Use only Virtually everywhere
Virtually everywhere
(FDA warning in non acute sites)
Requires s...
HBO TWO2 NPWT
Daily travel to facility for
90 min treatment
60 - 90 min treatment
at home
Continuous treatment
at home 24/...
As has been pointed out in many published reviews, the quantity and
quality of Randomized Controlled Studies for each of t...
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EWMA 2013 - Ep545 - Evidence Based Comparison of Three Advanced Adjunctive Wound Care Therapies in the Treatment of Diabetic and Venous Ulcers

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Mike Griffiths1 1AOTI (Oceanside, United States)

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EWMA 2013 - Ep545 - Evidence Based Comparison of Three Advanced Adjunctive Wound Care Therapies in the Treatment of Diabetic and Venous Ulcers

  1. 1. Mike Griffiths1 1AOTI (Oceanside, United States)
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.

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