Non-healing Wounds Treatment with Aquacel and Traumastem Biodress Comparison of Efficiency

uveřejněno: 08. 11. 2010

In this article we present results of the prospective, randomized study, comparing the results of the wound local therapy with two dressings: Aquacel and Traumastem Biodress.

Non-healing Wounds Treatment with Aquacel and Traumastem Biodress Comparison of Efficiency Final Report

Author: Jan Stryja MD Vascular and Minimally Invasive Surgery Centre Hospital Podlesí a.s., Třinec Konská 453 739 61 Třinec e-mail: jan.stryja@nempodlesi.cz

Summary In this article we present results of the prospective, randomized study, comparing the results of the wound local therapy with two dressings: Aquacel and Traumastem Biodress. Statistical results processing confirmed a significant difference in evaluation of the difference between ulcerations size after 8-weeks local therapy (p=0,038) in favour of Aquacel (i.e. 20 ±28,7 cm2 (median 9,7 cm2)) versus Traumastem (i.e.. 8,7 ± 15 cm2 (median 4 cm2)). In other measured parameters comparing the results of both dressings, no statistical significance was detected. Further the observation proved, that in the course of the study there was no increase of a bacterial load on the ulceration surface (73% of negative microbiological findings in the wound surface smears in both branches) or any clinical manifestation of early infection (13% each group). Based on our experience, we can fully support further clinical use of Aquacel and Traumastem Biodress.

Key words: ulceration, hydrofiber, Traumastem

Introduction An innovation of the dressing, so called „moist therapy“ is quite often effort of producers trying to extent a spectrum of materials for use in wounds local therapy. An evaluation of dressing materials effectiveness in extended indications cannot be performed without a clinical study, where we observe properties of the materials in the wound under „real“ conditions and consequent statistical evaluation of the results. In our contribution we evaluate a comparison of two dressing’s clinical efficiency: Aquacel (ConvaTec) and Traumastem Biodress (Bioster) with a group of 30 patients observed for 2 months in the Vascular and Minimally Invasive Surgery Centre of Hospital Podlesí. The objective of this observation was to prove a therapeutic effect of both dressings Traumastem Biodress and Aquacel in indications listed below, to evaluate patient´s compliance with a treatment and to compare mutually results of the wounds treated with two different dressings Material and methodology The project was realized as a randomized, prospective clinical study comparing the efficiency of wounds healing in the group of patients, locally treated with Aquacel dressing and Traumastem Biodress dressing. Both materials are indicated as primary dressing on non-healing wounds with moderate and strong exudation without obvious signs of early infection. Both materials have a bacteriostatic effect and ensure a favourable moist microclimate in the wound base. As a respond to exudate presence they create a gel. The producers state that both materials help cleansing of the wound base, induce a granulation process, quicken up the wound ephitalisation and can be applied on both chronic and acute wound. In the frame of the study preparation, the clinical protocol and the study plan were designed. After approval by the ethical committee in Hospital Podlesí, the study started in April 2009. In total 30 patients with non-healing wounds, who had been observed according to the clinical protocol for 2 months, were included into the study. Indications for application the tested wound dressings were following: diabetic foot syndrome, early surgical dehiscence complicated by healing disturbance of skin covering, ulcerations in patients with treated ischemia (degree Fontain IV) by arteriosclerosis obliterans of lower limbs arteries after revascularization, and ulcus cruris of venous and mixed (arterial-venous) etiology.

Excluding criteria were determined as follows: size of the ulceration less than 2 cm2. more than 200 cm2, infected wound, non-healed critical limbs ischemia (TcpO2 less than 10 mm Hg, malleolar index less than 0,5), incorrectly compensated diabetes mellitus, anaemia (haemoglobin less than 100 g/l), decompensate heart insufficiency, significant Hypoproteinemia (albumin less than 35 g(l), malignant tumour with generalization, general immunosuppressive therapy and allergy to administered substance. The patients meeting inclusion criteria were randomized in group A (N=15) which was treated with Aquacel dressing, and group T (N=15) which was treated with Traumastem Biodress. In both groups the wounds were treated by a standard nursing procedure which was a part of the clinical protocol. At the beginning of the observation the patients were randomized, The patients with non-healed limbs ischemia were excluded from the study; other excluding criteria are described in Chart 1. During the first week of the observation the rebandages of defects were performed daily, after that, till the end of 8th week, the ulcerations were rebandaged every other day. The ulceration rebandages were performed in an examination room of the surgical and podiatric department of the Hospital Podlesi, a.s.. With outpatients the rebandages were performed in home environment by trained nurses from a home care agency. A course of the wound healing, a tolerance of the dressing by patients and possible complications in the wound healing were continuously monitored during clinical checks. The ulceration size, wound base character and intensity of subjective early pain perception (VAS scale) were among the observed markers. The wound base was described by the rules of „WHC classification“ ((Gray, White, Cooper, 2002: The Wound healing continuum). At the end of the 8th week, the state of the wound was documented and the observation was finished by the clinical protocol. Before inclusion into the study, all patients were examined anamnestically, clinically, by Doppler´s ultrasonography of arteries with determination of ankle/arm pressure (ABI – ankle/brachial index) and by transcutaneuous pressure of oxygen TcpO2. There was performed a basic biochemical examination (CBC + diff, glycaemia, urea, creatinin, CRP, albumin, proteins) and bacteriological examination from the ulceration base. A presence of infection clinical signs on the wound base at the beginning of the study was a reason for exclusion (not inclusion) the patient from the observation.

Characteristic of used dressings Aquacel dressing (hydrofiber technology) represents an innovated material created by company ConvaTec, which has been on the Czech market since 2005. Currently it represents one of the standardly used dressings for non-healing wounds. Aquacel consists of smooth, non-woven primary dressing for wounds and cavities. Hydrocolloidal fibres (hydrofiber) of Aquacel are made of Na-carboxymethylcellulose and create a spatial mesh. A new production technology enabled to change classic properties of Na-carboxymethylcellulose contained in hydrocolloids and thereby created a dressing with different characteristics. The dressing absorbs an early secretion to the inside of a fibre, reacts with it and creates a smooth hydrophilic gel on the wound surface. The gel retains bacteria and adapts to the wound contour. The hydrofiber fibre helps moist environment, has a good ability to absorb the secret and reduces a maceration of the wound surroundings. It enables and helps autolytic debridement. Aquacel is indicated as a primary dressing on semi- or heavily exuding wounds and as prevention as well as therapy of the wound base and its surrounding´s maceration. With regard to its bacteriostatic properties it can be used even in therapy of contaminated and colonized ulceration. With application on slightly exuding wounds, it is suitable to moisten the dressing surface, which covers the wound base, with purified water or saline solution.

Traumastem Biodress is a sterile, resorbable bioactive dressing for wounds made of natural, oxidised cellulose; it is produced by company Bioster. The cotton fibres are spun by twisting of basic helixes, resulting in the hollow fibres with a larger specific area. In the Czech Republic it has been on the market since 2008. By its composition Traumastem Biodress is 100% hydrogen-calcium salt of oxidised cellulose. Traumastem Biodress influences metabolic and biochemical procedures effecting a damage tissue remodelling; significantly effects inactivation of matrix metalloproteinases, activates fibroblasts, decreases pH in the wound and has bactericidal effects. It also has an analgetic effect and ensures a favourable, moist microclimate in the wound. Thanks to its haemostatic properties Traumastem Biodress is suitable to stop bleeding from acute and chronic wounds. Traumastem Biodress is fully biodegradable; it is absorbed within 48 – 72 hours after application at the latest, depending on the quantity of exudate in the wounds. When applied on slightly exuding wound, it is suitable to moisten the dressing surface, which covers the wound base, with purified water or saline solution.

Observation Group A (Aquacel) consisted of 15 patients, 8 men (53%) and 7 women (47%). Average age of the group is 70,7± 7,87 years. Average value of BMI was 28,9± 2,23. All patients at that time were observed non-smokers. An average time of the wound persistence was 271 days at the beginning of observation, see Chart 2. With 10 patients (67%) preceded some form of „moist therapy“ in a local treatment, 5 patients (33%) were treated with „conventional therapy“. Only 3 patients (20%) evaluated existing therapy as without difficulties, the others described painfulness (73%), itching (33%), burning (27%) and reddening (13%). A percentage of ulcerations etiology was following: ischemia (33%), chronic venous insufficiency (67%), mixed etiology (ulcus cruris mixtur) (27%), peripheral neuropathy (27%), diabetes mellitus (40%), early dehiscence (20%). Average ABI value was 0,88 ±0,15 on the right lower limb and 0,9 ±0,15 on the left lower limb. Average TcPO2 value on the affected lower limb was 33,6 ±8,8 mmHg. The wound base was evaluated by median corresponding with yellow-red colour. (in both groups of patients) according to WHC. Average size of ulceration at the beginning of observation was 32,7 ± 34,12 cm2. Group T (Traumastem) consisted of 15 patients – 7 men (47%) and 8 women (53%). Average age of the group was 66,1 ±6,6 years. Only 1 of 15 patients was smoker. Average value of BMI was 28,5± 4,2. Average time of the wound persistence was 341 days at the beginning of observation. see Chart 2. With 12 patients (80%) preceded some form of „moist therapy“ in a local treatment, 3 patients (20%) were treated with „conventional therapy“. Only 3 patients (13%) evaluated existing therapy as without difficulties, the others described painfulness (67%), burning (60%), itching (27%), and reddening (20%). A percentage of ulcerations etiology was following: limb ischemia (47%), chronic venous insufficiency (53%), mixed etiology (ulcus cruris mixtur) (40%), peripheral neuropathy (20%), diabetes mellitus (60%), early dehiscence (20%). Average ABI value was 0,89 ±0,3 on the right lower limb and 0,84 ±0,1 on the left lower limb. Average TcPO2 value on the affected lower limb was 34,3 ±5,3 mmHg. The wound base was evaluated by median corresponding with yellow-red colour. (in both groups of patients) according to WHC. Average size of ulceration at the beginning of observation was 24 ± 24,7 cm2.

Statistic analysis Continuous values were expressed as median or arithmetic mean ± standard deviation. To determine differences´ significance between two groups of patients, the nonparametric Mann-Whitney U test was used. As statistically significant difference, p<0,05 value was determined. The analysis were performed by Statistica v.9.

Results A development of the wound base after 2 months is described in Chart 3. With patients treated with Aquacel there was a rightward shift about 2 degrees of WHC scale to reddish-pink colour. The ulceration size after 2 months treatment reduced from an average value 32,7 ± 34,12 cm2 to 12,74 ± 20,43 cm2. The difference was 20 ±28,7 cm2 (middle value 9,7 cm2). During the observation there was no increase of early infection complications compared to initial stage. Granulation of the wound base during the treatment with Aquacel dressing occurred with 13 patients (87%), where at the end of the observation the granulations created 85±15,6% of the wound surface. After 8 weeks we observed the epithelisation after the treatment with Aquacel in 13 patients (87 %); in one case the ulceration was entirely healed. The average value adequate to covering the wound with epithelium was 57 ± 40% of the wound surface. At the beginning of observation the patients evaluated the pain level as degree 4 by VAS. At the end of observation the average value was degree 2, there was decrease of two levels. At the end of observation the therapy effect was positively evaluated by 93% of respondents (20% at the beginning), 53% of patients were subjectively without any problems. In one case the therapy was interrupted due to an early infection, in one case we observed maceration of the surroundings but there was not necessary to interrupt untimely the observation. A development of the wound base after 2 months is described again in Chart 3. After 2 months therapy with Traumastem Biodress there was a „rightward shift“ about 1 degree on average of WHC scale to red colour The ulceration size after 2 months treatment reduced from an average value 24 ± 24,7 cm2 to 15,3 ± 25,3 cm2. The difference was 8,7 ± 15 cm2 . During the observation there was no increase of early infection complications compared to initial stage. The granulation the wound base during the treatment with Traumastem dressing occurred in 14 patients (93%). After 8 weeks we observed the epithelisation after the treatment with Traumastem in 12 patients (80 %). At the beginning of observation the patients reported the pain level as degree by VAS 4,47 ± 1,1, middle value 5. At the end of observation the average VAS value was 2, there was decrease of 3 levels. At the end of observation the therapy effect was positively evaluated by 87% of respondents (13% at the beginning), 67% of patients In two cases (13%) was the therapy by Traumastem interrupted – in one case for early infection and for surroundings maceration in the second case. In one case we observed granulation anhydrobiosis on the wound base with the dressing adhesion with insufficient wound secretion To find out the differences significance between the groups of patients treated with Traumastem Biodress and Aquacel, the non-parametric MWU test was used. A statistic processing of the results proved the significant difference in the ulcerations size, after 8 weeks of a local therapy (p=0,038) in favour of Aquacel dressing: (i.e. 20 ±28,7 cm2 (middle value 9,7 cm2) versus Traumastem (i.e.. 8,7 ± 15 cm2 (middle value 4 cm2)) With other measured parameters no statistical significance was found out.

Discussion The applied local therapy was well tolerated by the patients and with exception of sporadic cases of a manifest early infection the compliance with patients was very good. Both groups developed the granulation and epithelisation support, resulting in reduction of ulcerations area. Statistically significant by MWU test was the difference in ulceration area reduction after 8 weeks therapy in favour of Aquacel group (Aquacel 69,6% versus Traumastem 47%), p=0,031..During the therapy there was a decrease of perceived pain level about 2 (Aquacel) to 3 (Traumastem) VAS degrees. Probably, there is not sufficient number of observations in both branches of the study to reach the level of the statistical significance. The observation also proved that there was neither an increase of bacterial load on the ulceration surface (in both groups 73% of negative microbiological findings of the wound surface smears) nor a clinical manifestation of early infection (13% in each group). A systemic therapy and regime precautions including a correctly indicated external compression are necessary to reach a sufficient efficiency of the local therapy. To reach optimal results, it is necessary to keep recommended indications and the way of application on the wound.

Conclusion The study demonstrates that both tested dressings have comparable properties. Even if the chemical structure of both dressings and way of dressing´s interaction with the wound are different, both materials help surgical wounds healing. The materials were well tolerated by the patients and the usage of these did not lead to more often occurrence of early infection complications. On the basis of our experience we can fully support further clinical use of both Aquacel and Traumastem Biodress,

Literature Gray, D., White, R. J., Cooper, P. The wound healing continuum. British Journal of Community Nursing 7, 12, Supl 3: 15–19, 2002. Stryja J. Wounds Healing Handbook GEUM 2008, ISBN 978–80–86256–60–3: 151–152 Slonková V., Vašků, V. Using Oxidized Cellulose in Treatment of chronic Wounds with Venous Origin – Clinical Study Results Česko-Slovenská dermatologie. 2009. vol. 84. no. 2. p. 92–98. Zelenková, H. Application and Verification of Effectiveness and Safety of Traumastem Biodress Medical Device. Final Report Svidník. 2009

Gallery

Wound before starting treatment
Traumastem Biodress apliccation
Wound after 5days treatment
Wound after 1 month treatment
Wound after 2 months treatment
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