Clinical Observation of Effectiveness and Safety of Medical Device on Basis of Oxidized Cellulose:

uveřejněno: 26. 07. 2010

The clinical observation was carried out on the basis of predefined and known clinical data, with respect to stated properties of bandaging material. The target group consisted of patients with stagnating shinbone ulcerations of arterial and venous origin as well as diabetic foot. The observation was performed 7.10.2008 – 31.7.2009

Clinical Observation of Effectiveness and Safety of Medical Device on Basis of Oxidized Cellulose: MUDr. Stracenská J., MUDr. Zelenková H., CSc.,
Department of Dermatology and Venereology, Svidník, Slovak Republic

Specialization of clinical observation:

Our department was asked by company Bioster (Czech Republic) to perform the clinical observation of an effect of the medical device Traumastem Biodress, which is duly registered in Czech Republic and Slovak Republic. The clinical observation was carried out on the basis of predefined and known clinical data, with respect to stated properties of bandaging material. The target group consisted of patients with stagnating shinbone ulcerations of arterial and venous origin as well as diabetic foot. The observation was performed 7.10.2008 – 31.7.2009

Characteristic of product: Traumastem Biodress is 100% hydrogen-calcium salt of oxidized cellulose gained from cotton. It is defined as bioactive dressing for its influence on a tissue remodelling. Oxidized cellulose is bound on collagenous matrix. It modifies the microclimate in the wound by a bond and by inactivation of increased proteases level and wound exudate. The most significant stated properties of Traumastem Biodress are e.g. an ability to inhibit MMP, bactericidal and bacteriostatic effect against a wide spectrum of bacteria, full absorbability, atraumatic rebandaging, analgesic effect, haemostatic effect, ensuring of favourable moist microclimate in the wound – wet healing, hypoallergenic potential, suitability for all stages of healing. The basic indications for using Traumastem Biodress are venous ulcerations, arterial ulcerations, diabetic ulcerations, stagnating and non-healing wounds, pressure sores (decubitus), surgical wounds (surgery, gynaecology, orthopaedy, traumatology)

Methodology: Rebandages were carried out exactly by the standard nursery procedure, recommended by the producer, and patients were included or eliminated from the study according to accurately defined criteria for inclusion or elimination. The effect of the treatment, granulation, epithelisation, subjective pain perception in the wound and the dressing tolerance, bacterial population and objective signs of the healing were documented in reports. Number of patients: 23 (11 female, 12 male) of age 30 – 80 years, evaluation of local findings: totally 4× (on inclusion to the group and then in week intervals), used preparation: Traumastem Biodress (Bioster, a.s. Czech Republic), time of using: maximally 30 days; criteria for inclusion: a size of the defect more than 2cm2, length of current episode (non-healing) more than 3 months, failure of current therapy, medication administered at the same time: venopharmaceutics, analgesics and other medication recommended by a specialist, microbiological examination: wound smear in every clinical check of the patient.

Evaluation of clinical observation: Group I.  – ulcerations of venous origin Almost one third of the patients reported significant cleansing of the base after 6.- 8 days, a slight bleeding on the wound base appeared in some cases. The frequency of rebandages, at first once in 12 hours, later once in 24 – 48 hours, was convenient for all patients. The defects granulation and epithelisation occurred with all patients. Adverse effects – erythema, slight burning and pain disappeared shortly after application, they were present with 2 patients and, except for one case, they were not the reason to stop the application and eliminate the patient from the study. One patient interrupted the observation due to unbearable pain, burning and vesicles formation. In most cases, the effect of the treatment was evaluated by a doctor as very good chart 1. Tolerance of the used material was very good with 10 patients chart 2 Chart 3 and 4 show the pain in the wound at the beginning and at the end of observation.

Group II.  – ulcerations of arterial origin After 13 days of application, despite of objective improvement of the clinical state, one patient finished the observation and was withdrawn from the group due to unbearable pain. After 8 – 10 days of application, the defect bases were clinically cleansed and the finding was objectively improved. At first the rebandages frequency was once in 12 hours, later once in 24 – 48 hours and was convenient for the patients. Epithelisation and granulation in the wounds occurred with 2 patients. Undesirable side effects – erythema, slight burning and pain after the application were only temporary. Effect of the treatment chart 1 Tolerance of used material at the end of observation chart 2. Pain in the wound at the beginning and at the end of observation charts 3 a 4. Group III.  – diabetic ulcerations 6 out of 9 patients from observed group finished the study in the determined time. One patient stopped due to diabetes decompensation, one patient due the worsening of both general and local state and one patient for other health complication (hospitalisation in surgery ward and consequent amputation). After application, usually after 6 – 8 days, the defects bases were clinically cleansed and the finding was objectively improved. At first the rebandages frequency was once in 12 hours, later once in 24 – 48 hours and was convenient for the patients. Undesirable side effects – erythema, slight burning and pain after the application were only temporary. The effect of treatment at the end of observation was evaluated by a doctor as very good in most cases chart 1. Tolerance of used material at the end of observation chart 2. Pain in the wound at the beginning and at the end of observation charts 3 a 4.

Discussion: Getting to the close contact with the wound base, Traumastem Biodress actively kills micro-organisms, prevents secondary infection, has very good deodorant and analgesic effect, starts and accelerates the healing of chronic, stagnating wound. By our observations, it is not toxic or aggressive and it is non-allergic. The dressing is soft, flexible and is possible to form it. Its application is easy, fast and its full absorbability ensures atraumatic rebandages. Our observation confirmed its wide use for various types of defects. Traumastem Biodress significantly benefits to defects cleansing, creating of moist environment and acceleration of the whole healing process in all stages of healing.

Conclusion: The management of stagnating wounds treatment requires perfect orientation in treating materials, complete information about wounds aetiology and general state of a patient. Oxidized cellulose should become a regular part of our practice for its ability to start the healing process, especially of long-standing non-healing wounds, and for its analgesic properties, significantly improving patients quality of life, in case that basic internal and external factors, unfavourably influencing the treatment, are handled at the same time. In our opinion, based on our experiences, Traumastem Biodress has all properties guaranteed by the producer. We can recommend the product to be used not only during hospitalisation but mainly in ambulatory care and home care with patients (laymen) in the treatment of chronic wounds. The unique composition and the effect of the bioactive dressing Traumastem Biodress is undoubted enrichment of therapeutic portfolio not only of dermatologist but also surgeon or traumatologist. Thanks to this bioactive dressing, we have an extraordinarily effective tool to manage difficult, hard-to-heal chronic wounds.

chart.1 Effect of treatment with Traumacel Biodress – doctor´s evaluation chart 2 Tolerance of Traumacel Biodress chart 3 Pain in the wound at the beginning of observation chart 4 Pain in the wound at the end of observation

Gallery

Diabetic ulcer
Venous ulcer
THE EUROPEAN REGIONAL DEVELOPMENT FUND AND THE MINISTRY OF INDUSTRY AND TRADE OF THE CZECH REPUBLIC SUPPORT INVESTMENT IN YOUR FUTURE.