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ORIGINAL ARTICLE
Year : 2020  |  Volume : 7  |  Issue : 1  |  Page : 50-53

Topical NATROX® oxygen wound therapy on patients with ischemic foot ulcers – A case series


Jain Institute of Vascular Sciences, A Unit of Bhagwan Mahaveer Jain Hospital, Bengaluru, Karnataka, India

Date of Submission22-Jul-2019
Date of Decision23-Jul-2019
Date of Acceptance28-Oct-2019
Date of Web Publication16-Mar-2020

Correspondence Address:
Dr. S Roshan Rodney
Jain Institute of Vascular Sciences, A Unit of Bhagwan Mahaveer Jain Hospital, Bengaluru, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijves.ijves_43_19

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  Abstract 


Background: The essential role of oxygen in wound healing is well documented, and recent developments in the delivery of topical oxygen therapy have made this a more viable treatment in practice. This article examines the role of topical oxygen – the NATROX® Oxygen Wound Therapy System in wound healing and looks at the impact of increased oxygenation on ulcer healing through a case series where the NATROX system was used in patients with ischemic foot ulcers. Materials and Methods: Topical oxygen therapy was evaluated in patients with ischemic foot ulcers in a tertiary referral specialist center. Results: During this case series of six patients, four patients had a complete healing before the study completion and two patients wounds were on a healing trajectory (average reduction in wound size of 60 %) during the follow-up, which eventually healed. Conclusion: NATROX® is an innovative topical oxygen delivery system that warranty further research to assess its potential impact on wound healing.

Keywords: Ischemic, oxygenation, ulcers


How to cite this article:
Rodney S R, Vivekanand, Vishnu M, Sumanthraj K B, Chaudhari H, Davra D, Jain P, S Sravan C P, Lende V, Vishal H, Sivakrishna K, Nishan B. Topical NATROX® oxygen wound therapy on patients with ischemic foot ulcers – A case series. Indian J Vasc Endovasc Surg 2020;7:50-3

How to cite this URL:
Rodney S R, Vivekanand, Vishnu M, Sumanthraj K B, Chaudhari H, Davra D, Jain P, S Sravan C P, Lende V, Vishal H, Sivakrishna K, Nishan B. Topical NATROX® oxygen wound therapy on patients with ischemic foot ulcers – A case series. Indian J Vasc Endovasc Surg [serial online] 2020 [cited 2020 Apr 5];7:50-3. Available from: http://www.indjvascsurg.org/text.asp?2020/7/1/50/280671




  Introduction Top


Improving tissue oxygenation has long played an important role in wound healing. Impaired oxygen delivery to a wound can greatly inhibit the healing cascade. Topical oxygen therapy represents a less explored and less expensive modality in wound healing compared to hyperbaric oxygen therapy.[1] Topical oxygen therapy is the Food and Drug Administration approved for diabetic ulcers, venous insufficiency, postsurgical infections, gangrenous lesions, pressure ulcers, skin grafts, burns, frostbite, and amputations.[2] The objective of this analysis was to evaluate the efficacy of topical oxygen as an adjunct to wound healing in diabetic and patients with peripheral arterial disease after successful revascularization.


  Case Report Top


A case series involving six patients with ischemic ulcers after debridement/minor amputation and successful revascularization were studied using the NATROX for a period of 8 weeks.

Methodology

Patients with ischemic foot ulcers were selected from those being treated by the vascular team in the Jain Institute of Vascular Sciences, Bengaluru. Those with no significant wound reduction despite following the standard wound management protocol of our institute for a minimum of 4 weeks were included in the study. There were total ten patients intended to treat, but only six had consented for the study. There were no specific predetermined exclusion criteria when considering patients for treatment with this modality. All patients included had prior surgical debridement/minor amputation and successful revascularization prior to commencing NATROX oxygen delivery system (ODS).

Treatment regimen

The disposable NATROX ODS (Inotec AMD Ltd., Cambridge, England) was placed directly onto the wound bed to optimize the diffusion of oxygen. The secondary dressing regimens were dictated by wound condition and hospital wound management protocol. Patients returned to the foot clinic every week for the change of NATROX ODS, and each participant was followed up for 8 weeks. Wounds were photographed during each visit.


  Results Top


During this case series of six patients, four patients had a complete healing before the study completion, and two patients were on a healing trajectory (average reduction in wound size of 60 %) during the follow-up which eventually healed. Their case details are listed in [Table 1].
Table 1: Patient details

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All study cases after the serial application of NATROX are shown below [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6].
Figure 1: Right great toe amputation site (Case 1)

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Figure 2: Left transmetatarsal amputation site (Case 2)

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Figure 3: Left 2nd to 5th toe amputation site (Case 3)

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Figure 4: Right great toe amputation site (Case 4)

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Figure 5: Right transmetatarsal amputation site (Case 5)

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Figure 6: Left great toe amputation site (Case 6)

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  Discussion Top


The novel NATROX ® Oxygen Wound Therapy System represents a significant development in topical oxygen therapy, as it can provide a more practical mode of continuous oxygen therapy than a hyperbaric oxygen chamber or localized topical oxygen system, as it is a small, lightweight, portable, and easy to use.[1]

NATROX ® is a small portable device about the size of a mobile phone. Its function is to generate concentrated oxygen at 13 ms/h from the surrounding air and to deliver it down a thin flexible tube and through the ODS, so it can be diffused evenly across the wound bed.[1]

The NATROX device system consists of three main components as follows [1] [Figure 7]:
Figure 7: NATROX device

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  1. The NATROX ® oxygen generator (OG)


  2. No on/off switch; activation occurs when a fully charged battery is fitted

    Flashing green light indicates oxygen is flowing

  3. The NATROX ® battery


  4. Two batteries were supplied, one is fitted to the NATROX ® device, whereas the other is left on continuous charge

  5. The NATROX ® ODS


Sterile, single-use ODS connects to the OG providing oxygen directly to the wound bed.

This case series analysis looked at topical oxygen as a therapeutic option for diabetic and ischemic wounds. We did not limit our indications because we hoped to establish which, if any, wounds responded to topical oxygen treatment. There have been no reports of side effects from the topical oxygen, and this analysis showed that the majority of wounds achieved faster wound healing. In this relatively limited analysis, it does not appear that topical oxygen alone is adequate for the management of diabetic and ischemic ulcers.

This therapy should not be applied to patients with limb ischemia as indicated by a transcutaneous oxygen measurement ≤25 mmHg or large wounds with average initial wound area of 25.3 cm 2, mainly the patient would not respond to the therapy, because there is an increase in diffusion distance for the oxygen, and therefore, decreasing its effectiveness.[3]

Emerging evidence suggests that topical oxygen therapy may provide a novel solution. Clinical evidence generated so far shows that NATROX had a positive effect on healing in challenging and nonhealing wounds. Yu et al. showed that after 8 weeks of treatment in diabetic foot ulcer (DFU), 30% of the control group healed, whereas 90% healed in the NATROX ® arm.[4] A study by Kaufman et al. found 57% of DFUs and arterial ulcers healed after >25 days of NATROX ®.[5] Hayes et al. demonstrated 53% of wound size reduction after 8 weeks of NATROX ®, with 7/10 DFUs on healing trajectory.[6]

The science behind topical oxygen therapy is growing, as oxygen therapy has been shown to promote collagen synthesis and is beneficial for producing the extracellular matrices that support wound healing.[2],[6] There is a clinical evidence to show that NATROX has a role in managing DFUs, with early studies showing an improvement in would healing times.[6] The data presented here represent one of the first reported NATROX case series of patients in India for wound healing.

Some of the limitations in this analysis were wounds in this study had conjunctive applications of other topical therapies, which may have influenced the healing of wounds. The patient population was also complex with multiple comorbidities affecting wound healing. Thus, when evaluating the effectiveness of wound healing, it is important to account for these comorbidities.


  Conclusion Top


The vital role of oxygen in wound healing has long been acknowledged, and innovations in the method of delivery mark a potential new development in the application of topical oxygen therapy. Early evidence and these cases indicate the promising use of the NATROX as a topical portable ODS.

NATROX ® ability to manage and heal wounds faster offers not only clinical and patient benefits but also has the potential to offer health economic benefits as well. NATROX ® is an innovative topical ODS that warranty further research to assess its potential impact on wound healing.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Wounds International. Consensus Round table Meeting: Topical Oxygen Therapy for Healing Complex Wounds. London: Wounds International; 2018.  Back to cited text no. 1
    
2.
Kalliainen LK, Gordillo GM, Schlanger R, Sen CK. Topical oxygen as an adjunct to wound healing: A clinical case series. Pathophysiology 2003;9:81-7.  Back to cited text no. 2
    
3.
Gordillo GM, Sen CK. Evidence-based recommendations for the use of topical oxygen therapy in the treatment of lower extremity wounds. Int J Low Extrem Wounds 2009;8:105-11.  Back to cited text no. 3
    
4.
Yu J, Lu S, McLaren AM, Perry JA, Cross KM. Topical oxygen therapy results in complete wound healing in diabetic foot ulcers. Wound Repair Regen 2016;24:1066-72.  Back to cited text no. 4
    
5.
Kaufman H, Gurevich M, Tamir E, Keren E, Alexander L, Hayes P. Topical oxygen therapy stimulates healing in difficult, chronic wounds: A tertiary centre experience. J Wound Care 2018;27:426-33.  Back to cited text no. 5
    
6.
Hayes PD, Alzuhir N, Curran G, Loftus IM. Topical oxygen therapy promotes the healing of chronic diabetic foot ulcers: A pilot study. J Wound Care 2017;26:652-60.  Back to cited text no. 6
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
 
 
    Tables

  [Table 1]



 

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