SCIENTIFIC ELEMENTS OF LOCAL OXYGEN THERAPY AND MEANS OF APPLICATION TO PATIENTS
Ulcers of the lower limbs constitute a frequent pathology (1% of the population and 3.5% of the population over 65 years)
It mainly affects the female population with a rapport of about 3 to 1.
It is a chronic invalidating illness where the therapy is not standardized and it presents both medical and social problems.
In fact the treatment has elevated problems, not only medical but particularly social and among these particular relevance must be attached to the cost to the patient, to the collective and the cost to the National Health System.
Etiology of ulcerative injuries of the lower limbs
In outline they can be:
-phlebostatic: like complications of superficial venous sufficiency (varicose) or profound venous insufficiency (post-phlebitic syndrome)
-in collagenopathy for causes intrinsic to the illness or for habitual cortisone therapy
Types of therapy available
Medical: which includes pharmacological treatment (general and local) and combined treatment given with medications and medicines.
Surgical: both to eliminate the causes and to deal with complications up to plastic surgery.
Hyperbaric Chamber: based on the principle of oxygen therapy in hyperbarism.
Local hyperbaric therapy represents the evolutionary stage of that used in the last thirty years for the treatment of different pathologies linked to circulatory deficit or infective pathologies.
The oxygen administered acts on the devitalized or, however, suffering tissues with a contact mechanism and through the action of the component dissolved in the blood in part linked to the hemoglobin, in part dissolved in the blood as a free component (the latter represents the active component of the substance).
In the general hyperbaric chamber an increase of environmental pressure (hyperbarism) is obtained while the concentration or partial pressure of oxygen remains unchanged.
All this determines an increase in the availability of oxygen on the part of the tissues both as regards the contact component and that dissolved in the plasma.
There are side-effects that limit the use of the hyperbaric chamber. These are medical, personal and social. They can be summarized as follows:
Medical: cardiovascular, respiratory and cochleovestibulary illnesses
Personal : Psychological problems besides claustrophobia
Social: difficult availability (little or private), lack of bed-places, high costs of production and use and difficulty of hospital structure or of subjects at home in reaching the chamber with an increase in social and personal costs.
Oxygen therapy in normobarism
The solution to many problems of the hyperbaric chamber can be found in oxygen therapy in normobarism applied locally.
The main concept is that of enabling local application of the therapy performed in the hyperbaric chamber to pathologies of limited extension with the advantage of having absolutely no side-effects.
The concept of local normobaric therapy applies empirically in the principles and applications in different general Surgery Departments aimed at vascular treatment and in dermatology departments.
The work is not in hyperbarism but in normobarism and therefore not all the body is introduced in the hyperbaric chamber but just the part of the body requiring oxygen therapy.
Thus all the side effects are removed and both personal and social costs come down.
In the chamber for local oxygen therapy the percentage of oxygen internally (in contact with the injury) is about 95% compared with the 21-23% present in the general hyperbaric chamber. On the other hand the oxygen dissolved in the plasma increases to 2% volume with respect to the 6% which for the effect of hyperbarism is in the hyperbaric chamber. We obtain these values placing the mask on the patient and giving oxygen with this via the nose and mouth.
In this way (minor oxygen dissolved in the plasma, but increase in oxygen in contact with the ulcer) a therapeutic effect is obtained not unlike that obtained in the traditional hyperbaric chamber, since reduced hyperbarism is compensated by the increase in availability of oxygen, (in many surgical and dermatological departments and surgeries this type of therapy has been applied for years in an empirical and non-standardized manner, the oxygen being supplied through a polyethylene tube connected to the source, the environment is created through a plastic bag closed around the limb being treated). Criticism that may be made to such a therapy applied up to now was that of it being an empirical, artisan therapy: there was no precision regarding the concentration of oxygen, the concentration of humidity and the time taken was therefore subjective. And the there was a problem of image and aesthetics
The good results of the method led us to look for a more rational, repeatable and aesthetically pleasant application that guaranteed at the same time concentrations of oxygen, degree of humidity, known pressure values with predictable times of use.
We are also aware that fundamental elements that obstruct the therapies of phlebostatic ulcers and in general devitalized tissues are the reduction in tension of oxygen and the presence of exudate and necrotic tissue.
To resolve these difficulties optimization of oxygen therapy is being studied with the aid of active medicines introduced by nebulizer which reach the open injuries. Better oxygenation of the cells incentivated by medicines which act directly on the cell-cell mechanisms can be used in all devitalized tissues and also in diabetic injuries.
- Elevated compliance
- Documented effectiveness
- Low cost of purchase and use
- Easy availability of therapy
- Absolute absence of side-effects
- Rapid training of personnel
Recruitment of patients
1) Patients with phlebostatic ulcers
2) Patients with diabetic ulcers
Age: patients aged between 50 and 90 are eligible, sub-divided into classes
a) Between 50 and 60 years
b) Between 60 and 70 years
c) Between 70 and 90 years
Sex : males are distinct from females
Accompanying pathologies: must be indicated on the prospectus with the medicines being taken
Correlated orfavoured pathologies: must be indicated if there is a component
*arterial and phlebostatic mix
*of collagen with associated cortisone therapy
Evaluation and controls
- Presence of necrotic tissue
- Ease of bleeding
- Quantity and composition of exudate
- Presence and type of pathogens
- PH of the injury
- Deterioration of gradient of O2
- Peripheral neurological damage (in particular for diabetic pathology)
- Diameter of injury
- Depth of injury
- Incorrect handling of the illness
- Pain or burning or irritation of patient
Every 7 days the following data will be collected
1) Variations in the quantity of secretion
2) Variations in the type of secretion
3) Pain of the patient
4) Comfort of the patient
5) Ease of bleeding
6) Diameter of the injury
7) Depth of the injury
8) Tissue of granulation
Duration and method of treatment
- Variable depending on the pathology and the results and the course, (from two to six months), the data will be collected weekly and there will be an evaluation at between three and six months)
- The patient will have treatment daily 6 days out of 7
- The treatment will be for 1 or 2 hours per day (separated by 6 hours)
- The barometric pressure inside the chamber is not considered as it is not influential
- However one should evaluate the degree of humidity and the comfort of the patient depending on the degree of humidity which is varied adding water to the interior.
results acquired until today
Given that this concerns a chronic pathology the phlebostatic and the ischemic ulcer cannot reach definitive healing if the cause is not removed, thus a better quality of life must be aimed at; all cases treated have seen secretion diminish (100%), the subjective symptomatology improve (90%) while objective improvement has seen 85% of cases. In these a cleansing of the injury and a reduction of the diameter and marked evidence of the tissue of granulation have been noticed from the third day of application.
Over the course of the years we have experimented with extensive methods on the use of the device for the application of local normobaric therapy, on average dealing with 3 cases a week in our structure (Casa di Cura Rizzola in San Donà di Piave) and these cases have been followed personally over time.
To this we add patients followed in other structures like Codivilla Putti in Cortina and private structures and hospitals in other parts of Italy:
The type of ulcers treated were the following:
ischemic ulcers in ASO + mixed
preparations for dermo-epidermal transplants or injuries requiring reconstruction
or patients who have undergone dermo-epidermal transplants
The chamber mod. CID 700/A and following models has been distributed to some hospital facilities and private nursing homes, and considering the ease of use (treatment of subjects can take place both in hospital and inside the home), in this last period we have developed a simplified portable model defined as for the home. This model can be hired directly by the patient, who with the aid of a family member can provide their own therapy in the tranquility of the home and with the continuity that only this facility of application can permit.
This experience is producing very positive results, both from the therapeutic point of view and from that of the comfort of the patient, all harmonized with an extremely low social cost, both for the patient and for the health service.
We maintain that use of the local chamber for oxygen therapy for local use, can be a useful instrument, of low cost and without side-effects for a significant number of subjects affected by various pathologies but in particular for those who present devitalized injuries of the lower limbs. The ease of application and the absence of risk during use (the machine is absolutely independent from the electricity supply, and the flow of oxygen from 3 to 5 LT a minute does not alter the percentage of this in the environment) make it suitable for the widest variety of applications both in hospital, in the ambulance and in the home