That oxygen is essential for life is well established, but what is becoming increasingly recognised is that it is essential for wound healing as well. In clinical settings, oxygen is now being studied to better understand how it may be included in routine clinical use.
NATROX® is a class II medical device licensed under Medical Device Directive 93/42/EEC which enables clinicians to prescribe pure humidified oxygen applied directly to a wound to assist wound healing in chronic or non healing wounds.
NATROX® lightweight and compact size allows 24/7 oxygen therapy for patients at home or in the hospital setting. It can be worn under clothing during the day in the pouch provided and positioned comfortably at night.
How Does Natrox® Work?
The air you breathe contains only 21% oxygen. A wound when dressed and protected has very limited access to oxygen. The NATROX® generator produces oxygen by electrolysis, and 'delivers' it through a thin flexible tube to the unique Oxygen Delivery System (ODS) which is in direct contact with the wound surface. This continous supply of oxygen ensures an oxygen rich environment around the wound area. NATROX® is silent with no sensation of movement while providing a continuous flow (~13ml/hr) of 'pure' humidified oxygen.Watch our video
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Oxygen & Wound Care
How does Ambulatory Oxygen Wound Therapy work?
The basic premise of Oxygen Wound Therapy is that a healing wound demands greater than normal oxygen levels to allow many parts of a complex repair system to function properly. If oxygen demand outstrips supply, then the wound goes into a dormant state. We believe that Oxygen Wound Therapy delivers sufficient O2 into the wound bed to allow an increase in TCpO2 in the tissues around the wound, and we are commissioning research into how this occurs.
Some products already exist that deliver oxygen to the wound bed, but most involve the use of some kind of "container" such as a plastic bag or hard plastic box to trap oxygen around the leg or sacral areas and allow O2 concentrations to build up. While these devices have their merits, they greatly limit patient mobility and comfort and can be very expensive.
NATROX® intrudes very little, if at all, with any aspect of the patients normal activities, yet delivers sufficient quantities of humidified oxygen to the wound bed to allow key healing processes to restart.
Is Topical Oxygen Therapy (TOT) safe?
- NATROX® and ODS are CE marked, FDA approved and have been formally safety trialled in hospitals before being released for use on patients.
- NATROX® produces low flow humidified oxygen, so the chances of desiccating a wound are absolutely minimal.
- We recommend that NATROX® and TOT are only used on the advice of an experienced Clinician, preferably known to the patient.
- As NATROX® produces such a low flow of oxygen and does not store oxygen there is no risk of this becoming a fire hazard.
Topical Oxygen Therapy, Hyperbaric Therapy and Evidence based practiceEvidence based practice
- Topical Oxygen Therapy (TOT) has several centres supporting use, but similar to Hyperbaric Oxygen Therapy (HBO), a large body of grade 1 evidence does not yet exist.
- The main difference between HBO and TOT relates to the effects that above atmospheric pressure plays in increasing oxygen dissolved in the blood. The working theory is that during treatment, higher levels of dissolved oxygen diffuse throughout the tissues and assist wound healing. TOT is thought to work by having a pressure gradient of pure oxygen above the wound bed, which in turn leads to increased PO2 levels in tissues, where oxygen demand has outstripped oxygen supply due to the wound healing requirements being far above basal requirements.
- HBO requires a stay for some hours in a hyperbaric chamber usually with dressings removed. This treatment is very expensive and very few chambers are available whereas TOT is a continuous therapy where the patient remains fully mobile and requires lower treatment interventions from Clinicians.
- Inotec AMD recognise the requirement for evidence based medicine and are actively involved in a number of studies, including an application for a full randomised controlled trial (RCT). Patients with a wide range of diabetic leg and foot ulcers and non-healing lower leg wounds will be recruited. This will establish the efficacy of the NATROX® approach to applying TOT and bridge this gap in our knowledge. We presently have a growing number of case studies and case series, with results that firmly indicate positive benefits from NATROX® therapy.
- In recognition of the research required to meet evidence based practice requirements, we are offering NATROX® as a therapy that should be tried as an alternative to conventional therapies which have failed to heal patients. We believe that this approach is balanced, and consistent with the required 'do no harm' approach to medicine. We are continuously working with interested Clinicians to build up data on Oxygen Wound Therapy, by collecting wound outcomes on standardised case study report forms. If you would like to assist us in this research, please contact us via our email address.
- Oxygen Wound Therapy is easy to apply, portable, and low cost compared to other techniques such as HBO or Negative-pressure wound therapy (NPWT). As most patients with difficult to heal wounds are community based, it is helpful if they can receive Oxygen Wound Therapy 24hrs per day outside of the acute care facility where patients can go about their normal daily life, free of stress and anxiety often associated with hospital visits.
- We are conscious of the health economics that apply to the introduction of any new therapy in wound healing. Typical treatment costs are below $750 / $1,000 per patient in all but the most recalcitrant cases, and some patients have achieved complete healing well below that figure.
- Inotec AMD are striving to keep cost barriers to a minimum for any institution or clinic seeking to utilise this new technology. To this end, we have several ways to allow this use of one or more NATROX® purchasing methods which allow clinicians to cost effectively treat patients. As each clinical and budgetary need is likely to be different, Inotec AMD will work with you to make sure this technology is affordable in appropriate settings.
The NATROX® Oxygen Generator is the size and weight (107g) of a mobile phone and is supplied with two rechargeable battery packs one green the other blue. One will be in use while the other is on constant charge. A small green light flashes to let you know that oxygen is being produced. All items have been designed to be worn where it is most comfortable and battery packs designed to be easy to change even for patients with limited faculties including poor eyesight and grip strength. There is no ON/OFF switch, just connect a charged battery and begin Topical Oxygen Therapy.
Oxygen Delivery System (ODS)
Clinicians and patients have preferred wound dressings which they are familiar with and use regularly. These dressings not only protect but absorb fluids with many having an 'active' component. The ODS does not replace these dressings and is used with them, simply refreshing the wound with humidified oxygen, while allowing the free passage of wound fluids (exudate) to pass through the ODS for absorption and retention by the choice of standard wound care dressings.
The ODS is a 'single use' sterile circular 'web' design, welded from multi-layer medical grade materials. It is soft, flexible and designed to be placed directly on the wound surface. The construction allows oxygen to fill the ODS and then diffuse slowly through the lower layer only which is in direct contact with the wound surface. The ODS does not absorb or retain fluids, it simply distributes oxygen. Oxygen then enriches the 'headspace' above the wound surface and slowly diffuses out through dressing materials into the wound.
Trials reveal that the ODS is robust and presents no trauma when removed.
ODS may be used with 'active' dressings such as those containing zinc, honey and antimicrobial compounds.
ODSs come in a variety of packs and are sterile until opened.
There is a substantial body of evidence that oxygen plays a vital role in enabling wound healing to take place. Many chronic wounds may be prevented from healing by low oxygen levels in the tissues (local hypoxia), and this remains a challenge to most clinical units, as no easy, quick and inexpensive measurement of this parameter is available for routine use.
Studies have been performed to show that by improving tissue oxygen levels, wound healing systems will restart the healing process as long as other considerations are addressed adequately, e.g. nutritional state.
The improvement in tissue oxygen levels does not have to be a massive one, for beneficial effects to be observed, and such rises can be obtained through topical application of oxygen.
In a recent review article, Wild, Ebelstein, and Frye examined 27 published studies detailing the effects of Topical Oxygen Therapy on chronic wounds. In all 27 cited sources, beneficial effects were deemed to have been observed following the use of oxygen.
Egg White and oxygen therapy
Many of the senior nurses who have been approached with the NATROX® concept have spontaneously mentioned that during their training, it was common practice to administer egg whisked up with oxygen bubbling through it entrapping oxygen in the mixture and making this available to the wound surface. Whilst this practice would no longer be deemed appropriate, it does show that an understanding of the role of oxygen in wound healing has been around for decades.
Moist wound healing
One of the interesting aspects of how the NATROX® Oxygen Generator works, is that as a "by-product" of the electro chemical reaction, water vapour is produced. These newly formed molecules are sterile, and are used to humidify the oxygen flowing to the ODS. This humidified environment beneath the occlusive dressing is optimal for wound healing to occur.