Oxidized Cellulose in Treatment of Leg Ulcers Clinical Trial

12. 7. 2011

Oxidized Cellulose in Treatment of Leg Ulcers Clinical Trial

prim. MUDr. Georgios Karadzos Surgical Department, Hospital in Semily

Lenka Štrauchová, Dis. Bc. Edita Štrauchová Domiciliary Services, Semily

Summary The clinical trial with the purpose to prove the effect of hydrogen-calcium salt of oxidized cellulose during leg ulcers treatment, took place in Surgery Department of The Hospital in Semily in 2008. Patients with chronic leg ulcers of various aetiologies, persisting more than 2 months, were included in this trial.

Key words Leg ulcers, ulcus cruris, oxidized cellulose, hydrogen-calcium salt of oxidized cellulose

Introduction In the Czech Republic live around 100 thousand people suffering from leg ulcers – a difficult disease representing a serious health problem and having adverse impact on patients´ life quality. Leg ulcers are chronic disease with a long-term treatment and often recurrences. Defects are multiocular, in some cases bilaterally. They are present with 0,3 – 1% of productive population, more often with women than men, to higher extent with population of age above 65 years (4–6%)

Oxidized cellulose is 100% polymer of glucose, extracted from a plant material – cotton. The resorbable powder form of the local haemostatics on Oxidized cellulose basis has had a long tradition in former CSSR where it was applied in general, emergency and abdominal surgery in wide range of indications, from flesh wounds to applications into abdominal cavity. It was used also in neurosurgery, stomatosurgery and other surgery fields to stop diffuse capillary bleeding. A form of haemostatic reticulum has been gradually developed; it is used in wide indication spectrum in all surgery fields.

Traumastem Biodress is a brand new preparation from oxidized cellulose. By its chemical composition it is hydrogen-calcium salt of oxidized cellulose. It is a bioactive dressing, reducing a production of matrix metalloproteinase (MMP), activating fibroblasts and increasing growth factors´ quantity. Thereby it starts a healing process and accelerates phases of granulation and ephitalisation. Traumastem Biodress has also haemostatic effects. Hydrogen-calcium salt of oxidized cellulose has also antimicrobial effect against a wide range of gram-positive and gram-negative bacteria. Calcium ions are bound on beta pain receptors and they obstruct them. Thereby a pain in the wound is reduced and patient´s quality of life is improved. A significant advantage of this dressing is the fact that it is fully resorbable within 48 – 72 hours, depending on the exudate level.

Trial The trial took place in 2008 – 2009 in Surgery Department of The Hospital in Semily. The aim of this trial was to verify the effect of hydrogen-calcium salt of oxidized cellulose during leg ulcers treatment. Patients with chronic leg ulcers of various aetiologies, persisting more than 2 months, were included in this trial. The patients were treated with hydrogen-calcium salt of oxidized cellulose. Namely it was the product Traumastem Biodress, produced by Czech company Bioster. The product is supplied in form of reticulum of size 7,5×5 cm or 10×10 cm.

A sample group consisted of 6 patients (2 female and 4 male), average age 65 years. The average persistence of the disease was 47,75 months (with time span from 2,5 month to 20 years). With 5 patients there was a case of venous ulcerations, 1 patient with ulceration as a trauma consequence. 3 patients had bilateral leg ulcers, 3 patients with multilateral ulcers. Only 1 patient did not report any pain

Before the first application of Traumastem Biodress, the ulceration character was well documented. The base status, exudation level and the pain, perceived by the patient, were recorded. The wound was treated by a standard hygienic procedure and Traumastem Biodress was applied into the wound, according to the ulceration size. The reticulum was then covered with tulle gras, gauze layer and fixed with a bandage. The whole time of Traumastem Biodress application was 9 months. Rebandages were done after 1 or 2 days, depending on exudation level. The wound coating, exudate and later the ephitalisation of wound edges and granulation of the wound were checked every 2 days.

Results An average area of the ulcer before starting the trial was 203,66 cm2 with the observed group. After finishing the treatment, we observed complete healing of the ulceration with 2 patients, with remaining 4 patients was the final ulcer area 15,25cm2. Subjectively the patient stated decrease of the pain in the wound and significantly improved quality of life.

Discussion Traumastem Biodress is produced from hydrogen-calcium salt ox oxidized cellulose. The used oxidized cellulose is gained from long-fibre cotton of the highest duality. In the way of its processing it differs from the other forms of cellulose. The fibres are not pressed but spun by spinning, thus the specific fibre surface originates. This ensures a higher effectiveness of this OC, very good effect was observed with leg ulcers of various aetiologies. The process of cleansing and healing started with even several years old wounds. The study also proved a significant influence on reducing the pain in the wound. Two patients had the ulcers completely healed. Regarding the fact that leg ulcerations, mainly for its painfulness, are considered as factors markedly worsening quality of life, we can say that Traumacel Biodress significantly benefits to its improvement. We evaluate very positively Traumastem‘s ab­sorbability. It means that the dressing exchange does not traumatize a patient. We have not recorded any undesirable side effect connected with Traumastem Biodress application.

MUDr. Georgios Karadzos Surgical Ward, Hospital in Semily 3. května 421, 513 31 Semily georgios.karadzos@nemsem.cz

Lenka Štrauchová, Dis. Bc. Edita Štrauchová Domiciliary Services, Semily Nádražní 292, 513 01 Semily strauch@seznam.cz

If possible, attach the table:

Table Stated effects of Traumastem Biodress: • inhibits MMP • ensures a favourable, moist microclimate in the wound • antimicrobial effect • full absorbability • atraumatic rebandages • analgesic effect • haemostatic effect • hypo-allergenic • suitable for all stages of healing