Masterclass Guides: Continuous Topical Oxygen Therapy: NATROX® Oxygen Wound Therapy

May

- June 2022

GUIDES

Introduction

Continuous Topical Oxygen Therapy:

NATROX® Oxygen Wound Therapy

Continuous topical oxygen therapy (cTOT) is a modality of wound treatment involving the application of pure, humidified oxygen to the wound area to stimulate healing, by means of a specialized device.

This Masterclass Guide explores, in particular, NATROX® O2. It provides a concise but detailed summary of the specifications, key points, suitability of wound types and patients, and practical application of this device.

What Is NATROX® O2?1

■ The NATROX® O2 device (figure 1), is a small, portable unit which fits in the hand (figure 2). It consists of the NATROX® Oxygen Generator (OG), the NATROX® Oxygen Delivery System (ODS), and the battery (figure 3).

■ The OG is battery-operated and reusable. It is about the size and weight of a mobile phone, weighing 107g (3.7 oz)

■ The ODS is a sterile, single-use interface with a “wheel” shape to allow free passage of exudate into the secondary dressing while optimizing oxygen flow

■ The function of this device is to produce concentrated oxygen from the surrounding air, which passes through a flexible tube directly to wounds in need of advanced care. The device uses the natural properties of oxygen to stimulate and improve wound healing by delivering continuous, pure, humidified oxygen directly to the wound bed

■ Small, portable, lightweight, and rechargeable, giving patients complete freedom of movement. It can be applied across any healthcare setting, including in cases where treatment at home is more appropriate or convenient, or when self-administered by a patient

■ Can be used with other advanced wound therapies and secondary dressings

■ The system is supplied with 2 rechargeable, interchangable batteries

Keywords

■ Continuous topical oxygen therapy (cTOT)

■ Wound healing

■ NATROX® Oxygen Wound Therapy

■ Diabetic foot ulcer (DFU)

■ Wound

■ Wounds

■ Chronic wounds

How NATROX® O2 Works: The Ten Point Guide1

1 Prior to application, remove all old dressings and clean the wound using an aseptic technique, in accordance with local policies

2 Remove the ODS directly from packaging using an aseptic technique and apply directly to the wound bed, with the white side down

3 Remember to consider the position for the tubing for optimum patient comfort. The tubing can be positioned in any direction and, if necessary, can be secured with tape

4 Cover the ODS with a suitable absorbent dressing, sealing it to capture the oxygen produced by the device. You can use a dressing with an absorbent border, a bandage, or secure the edge with adhesive tape

5 After the dressing is secured, slide a fully charged battery into the device. There is no on/ off switch. Sliding the battery into the device will automatically start the device. Within 30 seconds, you will see the green light flashing which indicates that the oxygen is flowing

6 Connect the ODS to the OG using the twist and lock connector, being careful not to overtighten

7 The ODS should be changed whenever the secondary dressing is changed. However, it will need to be changed at least once a week

8 Fit the OG into the holster provided, or where the user feels most comfortable. The tubing must not be bent or distorted

9 The NATROX® O2 battery should be changed every 24 hours to ensure an uninterrupted supply of oxygen. Plug the battery into the charger (included with the kit) and leave charging all day. A flashing amber light indicates the battery is charging and a solid amber light means it is fully charged

10 To change the battery, slide the used battery out of the NATROX® O2 generator. Then slide the newly charged battery into the device, making sure it clicks into place. Charge the used battery to ensure it is ready for the following day

Continuous Topical Oxygen Therapy: NATROX® Oxygen Wound Therapy

What Types of Wounds Are Suitable?1

■ Non-healing surgical wounds

■ Diabetic foot ulcers

■ Venous leg ulcers

■ Pressure injuries

■ Chronic non-healing wounds

What Types of Wounds Are Not Suitable?1

■ Ulcers as a result of: thrombophlebitis, Raynaud’s disease, infection, tuberculosis, syphilis or deep fungal infections

■ Deep eschar

■ Fistulae or deep sinus tracts

■ Dressed wounds

■ Inadequate perfusion

■ Bites or third-degree burns

The NATROX® Battery

The NATROX® Oxygen Generator (OG)

The NATROX® Oxygen Delivery System (ODS) Initial

Figure 2: Scale of NATROX® O2 device

Figure 3: NATROX® O2 Components

Figure 4: Stages of treatment1

Continuous Topical Oxygen Therapy:

NATROX® Oxygen Wound Therapy

What Is the Evidence?

Oxygen levels have been shown to be depleted in certain wound types, such as diabetic foot ulcers, pressure, venous and arterial ulcers3. Oxygen is a vital component of the wound healing cycle, and the demand for oxygen exponentially increases in the healing wound; therefore, supplemental topical oxygen can assist in this process as well as promoting angiogenesis.

Efficacy Wound Size Reduction

Studies show patients with a chronic wound have a 71% greater chance of healing using NATROX® O2 than with standard of care alone5

■ “TO treatment is associated with induction in VEGF expression in the wound edge tissue and improvement in wound closure outcome. Approaches to topically oxygenate exposed dermal wound tissue warrant serious interest.”3

■ Topical oxygen therapy is associated with pain relief and reduction in the need for pharmacological analgesia4

■ In patients with painful ulcers, 76% felt rapid pain relief, 69% stopped taking opioids, and 53% became pain free4

■ Topical oxygen therapy results in a statistically significant improvement in healing rates for DFUs graded IDSA 1 or 25

■ “NATROX O2 is associated with a higher rate of complete wound healing in DFU when added to standard care.”5

Yu et al. conducted a trial using NATROX® Oxygen Wound Therapy to treat DFUs, involving 20 participants6:

■ The therapy was performed weekly, for a period of 8 weeks

■ The wound size was significantly reduced compared with baseline in the NATROX® O2 group

■ Prior to the trial, the DFUs were present without healing for a mean duration of 76 weeks

■ In both groups, all grade 1 ulcers healed with complete wound closure

■ In the NATROX® O2 group, all grade 2 ulcers healed compared with none in the control group

■ In the NATROX® O2 group, 50% of grade 3 ulcers healed, compared with none in the control group

Kaufman et al. report the following results of an observational study using NATROX® O2 to treat a variety of cases, including venous leg ulcers, arterial ulcers, DFUs, trauma, burns, post-operative wounds and pressure ulcers7:

■ Adherence with the treatment was 88% and there was a mean reduction in wound area of 7% per week

■ For patients treated for more than 25 days, 31 of 65 wounds healed completely

■ There was no statistically significant differences between the groups, but non-healing ulcers tended to be larger, with a longer duration

Costs

This technology is more cost-effective and convenient compared to other methods, for reasons including:

■ Suitable for self-care in a home setting, meaning hospitalisation may not be necessary at all

■ Low cost of device

■ Small, light, wearable

■ Minimal training necessary

■ Ease of use means the therapy can be performed quickly and efficiently

Can help alleviate the growing cost of chronic wounds, as evidenced by:

■ Meta-analysis suggesting cTOT significantly increases the likelihood of ulcer healing compared to controls18

■ 85% of patients of patients treated with NATROX® O2 remained healed at 1 year19

■ Amputation rates being significantly lower when cTOT is used in conjunction with standard of care20

NICE Briefing of NATROX® O2 Studies2:

3 studies, a randomised controlled trial and 2 observational studies – a total of 172 adults in secondary care. They show that NATROX® O₂ effectively treats a range of chronic wounds, and is more effective than standard of care in people with grade 2 and grade 3 diabetic foot ulcers.

Kaufman et al. study: “Important real-world data from consecutive cases.”

Yu et al. study: “This was a high-quality study with well-defined interventions and patient groups. Ulcers were graded with the widely used University of Texas diabetic foot ulcer classification.”

Continuous Topical Oxygen Therapy: NATROX® Oxygen Wound Therapy

Key Points

■ Designed simply to heal wounds

■ Easy to use

■ Compatible with all secondary dressings

■ Lightweight and portable

■ 71% greater chance of healing (compared to standard of care alone)5

■ Works across all care settings

References

1. NATROX® Wound Care. NATROX® O2. [Internet]. 2022. https://www.natroxwoundcare.com/natrox-o2/ [accessed 03/06/2022]

2. National Institute for Health and Care Excellence. NATROX oxygen wound therapy for managing diabetic foot ulcers and complex or chronic non-healing wounds. NICE Medical technologies guidance 17. [Internet]. 2020. https://www.nice.org.uk/advice/mib208 [accessed 03/06/2022]

3. Gordillo GM, Roy S, Khanna S, Schlanger R, Khandelwal S, Phillips G, Sen CK. Topical oxygen therapy induces vascular endothelial growth factor expression and improves closure of clinically presented chronic wounds. Clin Exp Pharmacol Physiol. 2008 Aug;35(8):957-64. doi: 10.1111/j.1440-1681.2008.04934.x. Epub 2008 Apr 21. PMID: 18430064; PMCID: PMC2574754.

4. Jebril W, Nowak M, Palin L, Nordgren M, Bachar-Wikstrom E, Wikstrom JD. Topical oxygen treatment relieves pain from hard-to-heal leg ulcers and improves healing: a case series. J Wound Care. 2022 Jan 2;31(1):4-11. doi: 10.12968/jowc.2022.31.1.4. PMID: 35077209.

5. Serena TE, Bullock NM, Cole W, Lantis J, Li L, Moore S, Patel K, Sabo M, Wahab N, Price P. Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial. J Wound Care. 2021 May 1;30(Sup5):S7-S14. doi: 10.12968/jowc.2021.30.Sup5.S7. PMID: 33979229.

6. Yu J, et al (2016) Topical oxygen therapy results in complete wound healing in diabetic foot ulcers. Wound Repair and Regenerations. 24 1066-1072

7. Kaufman H, Gurevich M, Tamir E et al (2018) Topical oxygen therapy stimulates healing in difficult, chronic wounds: a tertiary centre experience. J Wound Care 27(7): 426–33

8. Jonsson K, Jenson JA, Goodsen WH et al (1991) Tissue oxygenation, anemia and perfusion in relation to wound healing in surgical patients. Ann Surg 214(5):605-613

9. Knighton, D et al (1981) regulation of wound healing and angiogenesis – effect of oxygen gradients and inspired oxygen concentrations. Surgery.90: 262-70

10. Lordish, H et al (2000) Molecular cell biology. 4th edt New York: Freeman.

11. Babior, BM (1978) Oxygen- dependent microbial killing by phagocytes. New England Journal of Medicine. 298: 659-668

12. Sundaresan, M et al (1996) Regulation of reactive oxygen species generation in fibroblasts by Rac1. Biochemical Journal. 318: 379–382.

13. Sen, CK (2003) The general case for redox control of wound repair. Wound Repair Regeneration. 11: 431–438.

14. Stephens, F et al (1971) Effects of changes in inspired oxygen and carbon dioxide tensions on wound tensile strength. Annals Surgery 173: 515

15. Asmis, R et al (2010) Low-Flow Oxygenation of Full-Excisional Skin Wounds on Diabetic Mice Improves Wound Healing by Accelerating Wound Closure and Reepithelialization. International Wound Journal. 7: 349-357.

16. Kimmel, HM et al (2016) The presence of Oxygen in Wound Healing. Wounds. 28(8) 264-70

17. Nauta, TD et al (2014) Hypoxic signalling during tissue repair and regenerative medicine. International Journal Molecular Science.15(11):19791-815

18. Shivshankar T, Singh T, Golledge J. Topical oxygen therapy for diabetes‐related foot ulcers: A systematic review and meta‐analysis. Diabetic Medicine 2021 38:e14585.

19. Al-Jalodi O, Kupcella M, Breisinger K, et al. A multicenter clinical trial evaluating the durability of diabetic foot ulcer healing in ulcers treated with topical oxygen and standard of care versus standard of care along 1 year post healing. International Wound Journal. 2022;1-5

20. He S, Liang C, Yi C, Wu M. HYPERLINK “https://pubmed.ncbi.nlm.nih.gov/33713718/” Therapeutic effect of continuous diffusion of oxygen therapy combined with traditional moist wound dressing therapy in the treatment of diabetic foot ulcers. Diabetes Res Clin Pract. 2021; 174:108743.

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