Introduction
This Masterclass Guide is a concise overview aimed at exploring the use of Topical Wound Oxygen Therapy (TWO2) and incorporating this into your practice.
TWO2 is a unique multi-modality topical oxygen therapy that combines Oxygen, Compression and Humidification (Figure 1).
Most difficult to heal wounds have complicated etiologies resulting in an oxygen deficit in the wounded tissue. Furthermore, superior wound healing can only occur at oxygen levels greater than those delivered by a healthy blood supply (Figure 2).
The TWO2 therapy extremity system (Figure 3) is comprised of three major components: A single use Extremity Chamber (Figure 3b), Controller (Figure 3a) and oxygen source.
An oxygen flow rate of 10 LPM is used to cycle the therapy pressure between 10 and 50 mb directly at the wound site, within a sealed environment, providing an oxygen partial pressure diffusion gradient of close to 800 mmHg. The therapy offers the option of humidification with the goal of maintaining an ideal moisture balance for healing.
This allows for the maximum penetration of oxygen into the wounded tissue. Simple on-screen step-by-step instructions provide easy direction for patients and caregivers to apply the therapy at home. 12
■ The TWO2 therapy Multi-Patch system is comprised of two major components: A single use Multi-Patch chamber (Figure 3c) and an oxygen source. An oxygen flow rate of ≈ 4 LPM applied into the chamber delivers 30 mb of non-contact pressure directly to the wound site, within a sealed and humidified environment.
The resultant oxygen partial pressure diffusion gradient of about 800 mmHg provides for maximum penetration of oxygen into the wounded tissue, penetrating into tunneling wounds, thereby stimulating healing at the deepest point of injury. 1,8
Oxygen
Higher pressure delivery results in greater tissue diffusion, upregulating wound metabolism, resulting in faster and more durable healing.
Cyclical Compression
Non-contact, cyclical-compression helps to reduce edema, enhance peripheral vascular circulation and stimulate neovascularization.
Humidification
Assures an ideal wound healing environment for effective healing.
Keywords
■ Advanced Oxygen Therapy Inc. ■ Wound repair
■ Regenerative healing ■ Complex wounds
■ Topical Oxygen Therapy ■ Peripheral Artery Disease
■ Diabetic Foot Ulcers ■ Edema
How TWO2 Therapy Works:
Click for mechanism of action
Benefits of Supplemental Oxygen
TWO2 provides the highest penetration of oxygen into the wounded tissue. The immediate availability of oxygen at a partial pressure of approximately 800 mmHg provides the greatest diffusion gradient into the tissue and supercharges cellular activity.
TWO2 propels stalled, non-healing wounds into a robust healing pathway by addressing hypoxia. Increased oxygen levels upregulate enzyme production responsible for the immune response to fight infection, increase angiogenesis, stimulate better organized collagen deposition, and epithelialization. Collectively, this allows for a faster, more organized wound closure resulting in durable sustained healing. 1
■ Benefits of Cyclical Compression
The non-contact cyclical compression provided is between 10 mb and 50 mb pressure that is equivalent to a level 3 conventional compression dressing (CCD). This helps to reduce both edema and the hydrostatic pressure in the lower leg that is a frequent component of lower extremity peripheral vascular disease. The cyclical nature of the pressure delivery eliminates concerns when treating ischemic wounds. 1
■ Benefits of Humidification
A medical nebulizer delivers particulate humidity to the chamber to create an ideal moist wound healing environment. 1
Acute and Chronic Wound Indications 8 Contraindications 13
■ Diabetic ulcers ■ Frostbite ■ Acute thrombophlebitis
■ Pressure Ulcers ■ Skin grafts ■ Deep vein thrombosis
■ Venous Leg Ulcers ■ Post-Surgical Wounds
■ Infected Stumps ■ Burn wounds
■ Treatment of Acute and Chronic Wounds
What Is the Evidence?
Multimodality cyclical-pressure Topical Wound Oxygen (TWO2) therapy has been proven in multiple clinical studies to deliver faster, better quality, and more sustainable wound healing. TWO2 is an especially effective adjunctive treatment modality for chronic non-healing and acute complex wounds. 4
Recent high-quality double-blinded, randomized controlled trial (RCT) and real-world evidence (RWE) studies have demonstrated that TWO2 therapy results in more durable healing and provides significant clinical, quality of life and cost saving benefits. 2,4,9,10,11
|
Efficacy |
A study conducted in DFU patients found that TWO2 was associated with “…significant reductions in hospitalizations and amputations in the real-world setting” over 12 months. 2
The authors conclude: “…6.6%
and 12.1% of TWO2 patients had
hospitalizations and amputations,
respectively, compared with 54.1% and 41.4% of NO TWO2 patients… representing 88% and 71%
reductions. In matched cohorts
82% fewer TWO2 patients were hospitalized… and 73% fewer TWO2 patients had amputations… Logistic
regression among matched cohorts demonstrated nearly ninefold and fivefold higher risk of hospitalization and amputation, respectively, for NO TWO2 versus TWO2.” 2
■ A robust double-blind placebo controlled RCT in DFU concluded that ”…at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.”
■ “TWO2 is prudent, effective, and valuable in managing VLUs without the risks of full body hyperbaric chambers. The TWO2 slashes the time needed for VLU healing and is successful in pain alleviation, MRSA elimination, and management.” 3
“TWO2 radically degrades recurrence rates, thus providing an improved
quality of life.” 3
|
Patient Comfort |
■ In VLUs, TWO2 is associated with Click for patient testimonial videos
significant reduction in pain. 3
■ Patients administer TWO2 therapy at home while enjoying activities such as reading, watching television, or the
like. 5,8
■ At-home therapy improves compliance and access to care helping to address health inequalities.
|
Costs |
In the healthcare system, patients with chronic diseases account for the vast majority of healthcare spending. By more durably healing those ulcers and
lessening the reoccurrence, TWO2 has a direct impact on health economics and cost savings. 2,9,10,11,14
■ As an at-home therapy, TWO2 can help reduce costly hospital stays. 2,9,10,11
■ TWO2 provides an easy to use and more cost-effective means of delivering oxygen to the wound. 2,9,10,11
■ Multiple studies state that it would be cost-effective compared to hyperbaric oxygen therapy. 2,9,10,11
■ In the United States, TWO2 is reimbursed throughout the Veterans Administration and other government sectors under an awarded Worldwide Federal Supply
Schedule Contract. Additionally, TWO2
is also reimbursed by New York State
Medicaid. 5
92 Wound
Key Points 4
■ Unique multi-modality topical oxygen therapy that combines pressurized oxygen, non-contact cyclical compression and humidification
■ 88% reduction in hospitalization over 12 months
■ 71% reduction in amputations over 12 months
■ 6x more effective in complete healing in 12 weeks
■ 6x lower recurrence rates at 12 months
■ Well tolerated by patients, not associated with discomfort or pain
■ Supported by the highest level scientific studies
“We believe that in this rather robust double-blinded RCT we have clearly demonstrated the positive effects of cyclical, pressurized topical oxygen therapy in the healing of chronic diabetic foot ulcers. Accordingly, we now have the evidence required to recommend the use of this therapy as an adjunct to good standard care for the management of difficult-to-heal diabetic foot ulcers.” 7“Mainstay of my practice…most superior system.” Dr. Guberman, Podiatric Surgeon 6“Remarkable results” Dr. Hingorani, Vascular Surgeon 6”It’s a Win/Win… All the way around” Cathy Smith, CWON, FNP-BC, FPA-APRN 6
References
“We believe that in this rather robust double-blinded RCT we have clearly demonstrated the positive effects of cyclical, pressurized topical oxygen therapy in the healing of chronic diabetic foot ulcers. Accordingly, we now have the evidence required to recommend the use of this therapy as an adjunct to good standard care for the management of difficult-to-heal diabetic foot ulcers.” 7“Mainstay of my practice…most superior system.” Dr. Guberman, Podiatric Surgeon 6“Remarkable results” Dr. Hingorani, Vascular Surgeon 6”It’s a Win/Win… All the way around” Cathy Smith, CWON, FNP-BC, FPA-APRN 6
1. Mechanism of Action. Advanced Oxygen Therapy Inc., 2022 [Internet]. https://aotinc.net/healthcare-professionals/#mechanism-of-action [accessed 02/10/2022].
2. Yellin JI, Gaebler JA, Zhou FF, Niecko T, Novins O, Ockert A, Krzynowek D, Garoufalis MG, Lee AM, Frykberg RG. Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes. Adv Wound Care (New Rochelle). 2022 Dec;11(12):657-665. doi: 10.1089/wound.2021.0118. PMID: 34714167.
3. Tawfick WA, Sultan S. Technical and clinical outcome of topical wound oxygen in comparison to conventional compression dressings in the management of refractory nonhealing venous ulcers. Vasc Endovascular Surg. 2013 Jan;47(1):30-7. doi: 10.1177/1538574412467684. PMID: 23223182.
4. Clinical Evidence. Advanced Oxygen Therapy Inc., 2022 [Internet].https://aotinc.net/clinical-evidence/ [accessed 02/10/2022].
5. Products. Advanced Oxygen Therapy Inc., 2022 [Internet]. https://aotinc.net/products/ [accessed 02/10/2022].
6. A Level of Evidence Like No Other. Advanced Oxygen Therapy Inc., 2022 [Internet]. https://aotinc.net/ [accessed 02/10/2022].
7. Frykberg RG, Franks PJ, Edmonds M, Brantley JN, Téot L, Wild T, Garoufalis MG, Lee AM, Thompson JA, Reach G, Dove CR, Lachgar K, Grotemeyer D, Renton SC; TWO2 Study Group. A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study. Diabetes Care. 2020 Mar;43(3):616-624. doi: 10.2337/dc19-0476. PMID: 31619393.
8. Wound Sites and Types. Advanced Oxygen Therapy Inc., 2022 [Internet]. https://aotinc.net/products/#wound-sites-and-types [accessed 02/10/2022].
9. Chan BC, Campbell KE. An economic evaluation examining the cost-effectiveness of continuous diffusion of oxygen therapy for individuals with diabetic foot ulcers. Int Wound J. 2020 Dec;17(6):1791-1808. doi: 10.1111/iwj.13468. Epub 2020 Jul 27. PMID: 33189100; PMCID: PMC7754389.
10. Agarwal V, Aroor S, Gupta N, Gupta A, Agarwal N, Kaur N. New Technique of Applying Topical Oxygen Therapy as a Cost-Effective Procedure. Indian J Surg. 2015 Dec;77(Suppl 3):1456-9. doi: 10.1007/s12262-015-1215-x. Epub 2015 Mar 24. PMID: 27011599; PMCID: PMC4775658.
11. Sayadi LR, Banyard DA, Ziegler ME, Obagi Z, Prussak J, Klopfer MJ, Evans GR, Widgerow AD. Topical oxygen therapy & micro/nanobubbles: a new modality for tissue oxygen delivery. Int Wound J. 2018 Jun;15(3):363-374. doi: 10.1111/iwj.12873. Epub 2018 Jan 5. PMID: 29314626; PMCID: PMC7950116.
12. Products. Advanced Oxygen Therapy Inc., 2022 [Internet]. https://aotinc.net/products/ [Accessed 06/10/2022].
13. Healthcare Professionals, FAQ. Advanced Oxygen Therapy Inc., 2022 [Internet]. https://aotinc.net/healthcare-professionals/faqs/ [Accessed 07/10/2022].
14. Advanced Oxygen Therapy Inc. (AOTI). WebsEdgeMedicine/ ADA TV. [Internet]. https://www.youtube.com/watch?v=jdAyBImj13s [Accessed 07/10/2022].