Topical treatment of partial thickness burns by silver sulfadiazine plus hyaluronic acid compared to silver sulfadiazine alone a doubleblind, clinical study
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Slide 1 :
Silver sulfadiazine added with hyaluronic acid for the treament of partial thickness burns, a double blind clinical study Jan Koller , M.D., CSc Associated Professor of Surgery Department for Burns and Reconstructive Surgery, University Hospital Bratislava, Ruzinovska 6, Bratislava, Slovakia email@example.com In: Drugs under experimental and clinical Research. – Vol. 30, No. 5/6 (2004), p. 183-190
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BURN WOUNDS Specific types of wounds: large suface various amounts of necrotic tissue primary contamination edema massive exsudation source of pain absorption of toxic and other substances
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TOPICAL TREATMENT OF BURNS PRINCIPLE REQUIREMENTS Delay/minimize wound colonization Reduce invasive burn infection Activity against most common pathogens Low toxicity Minimal resorption through the wound surface Patient comfort-no pain at application/removal Should not delay wound healing
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TOPICAL TREATMENT OF BURNS HISTORY (XIXth, ½ of XXth century) Caustic agents, tannic acid, carbol, silver nitrate etc Tulle-gras (closed method by Koch ) RECENT METHODS Silver nitrate 0,5 % solution (Moyer 1965) Sulfamylon (Lindbergh 1968) Siver sulfadiazine (Fox 1968) Others: Betadine, Chlorhexidine, Cerium sulfadiaz.
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Silver Sulfadiazine (SSD) Most extensively used topical agent worldwide Combines the olidodynamic bacteriostatic activity of the heavy metal compound – silver with the wide – spectrum bacteriostatic action of the sulphonamide compound - sulfadiazine Atibacterial properties against Gram +, Gram -, some fungi Minimal systemic resorption Practically no systemic toxicity Painless application, good local tolerability Low penetration into avascular tissues (necroses) Minimal incidence of allergic reactions Prolongation of the wound healing time
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Hyaluronic Acid (HA) High molecular weight polyanionic polysaccharide (glycosaminoglycan, GAG) Natural compound of all the connective tissues (skin, mucosa, cartilage, eyes, synovia) Important mechanical and structural functions Plays important role in wound healing processeses Triggers macrophagic response, angiogenesis Well documented efficacy in slow-recovery ulcerative lesions Week antibacterial properties
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Silver sulfadiazine added with hyaluronic acid Combination of anti-infective action of SSD with healing enhancement of HA Reduction of local edema Reduction of excessive inflammation Reduction of pain Increase of patient´s comfort Reduction of the healing time
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Prospective, randomised, double blind controlled study Study preparations: Group A – SSD + HA 18 patients. Group B – SSD 15 patients Indications: IInd degree (superficial) and deep IInd degree (deep dermal) thermal burns Aims of the study: Efficacy Tolerability
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SSD + HA study design33 patients INCLUSION CRITERIA Age range: 18 to 80 years Burns: IIa and IIb >5% of the BSA Signed informed consent Two parallel groups created by computer-assisted randomisation (SSD+HA vs.SSD alone) Two study preparations in identical 25g tubes containing identically looking white creams The study was approved by the Ethical Committee of the Ruzinov University Hospital, and was in accordance with the Declaration of Helsinki and its later amendments
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SSD + HA study design33 patients EXCLUSION CRITERIA History of diseases: cardiovascular, haematologic, endocrine, gastrointestinal, hepatic, renal, CNS Patients on long-term drug treatment due to other pathological findings Known pregnancy Patients with history of drug and alcohol abuse
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TREATMENT METHOD Wound cleansing by sterile saline solution Application of the cream directly from the tubes epicutaneously on the cleansed wound Spreading on the wound by sterile woodden spatulas in an amount of approximately 5g/100cm2 Coverage by several layers of sterile fine mesh gauze Fixation by circular bandage Reapplication every 24 hours following cleansing of the wound from the older medication Duration of treatment 4 weeks maximum, or until complete wound epithelization
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EVALUATION CLINICAL On days 1, 7, 14, 21, 28 post treatment Residual burn wound area (in % of the pre-treatment value) Time to healing (total time in full days) Local oedema, as assessed by the investigator: 4-point severity scale, going from 0=absent to 3= severe edema Pain, as assessed by the investigator: 4-point severity scale, going from 0=absent to 3= severe pain; Local infection, evaluated as present or absent Patient’s and investigator’s assessment on the global response to therapy: 4-point scale (none, fair, good, excellent) Local tolerability, as assessed by both the investigator and the patient: 4-point scale (bad, fair, good, excellent);
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EVALUATION LABORATORY INVESTIGATIONS Department of Biochemistry and Department of Haematology of the Ružinov General Hospital · hematological (RBC, Hemoglobin, Hematocrit, WBC, Platelets) · biochemical (Glucose, Uric Acid, Urea, Creatinine, Total Proteins, Total Bilirubin, AST, ALD, GGT, Alkaline Phosphatase) · urine analysis Serological screening and bacteriological investigations were performed by the State Health Institute, Ružinovská 8, Bratislava.
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EVALUATION Statistical methods The completed case record forms were transferred to an independent organization (IBIS Informatica & Idee S.r.l., Milan - Italy) for the data management operations and the final statistical analysis. Continuous variables - analysis of variance (ANOVA) with repeated measures. Multiple comparisons - Student’s t test for unpaired data Discrete variables Wilcoxon Signed Rank test (within group) Kruskal-Wallis test (between groups), Fisher´s exact test, ?2 test and linear trend test according the variable nature.
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RESULTS Demographics and Baseline Characteristics
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RESULTS Extent and Severity of Burned Skin Area (in %) Basal value, at inclusion.
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RESULTS Residual Wound Area (in %, with respect to pre-treatment value) as assessed after 7, 14 and 21 days of treatment
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RESULTS Time to complete healing of the wounds
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RESULTS Local oedema, mean score at the different control visit in the two treatment groups (* p<0.05 between groups, Kruskal-Wallis test)
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RESULTS Pain, mean score at the different control visit in the two treatment groups. No statistically significant difference (Kruskal-Wallis)
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RESULTS Biochemistry, serology, bacteriology The principal biochemical, serological, and hematological values were not altered by topical application of the product.
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CONCLUSIONS I. · Addition of HA to SSD proved to overcome one of the very few disadvantages of SSD, i.e. the delayed wound re-epithelization. · Statistically significant shortening of the time to complete healing in IIa and IIb degree burns was achieved. · Statistically significant difference was found between treatment groups and in favour of the HA-SSD combination product, also in term of residual burn area, both after 7 and 14 days of treatment.
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CONCLUSIONS II. · Reduction of the local edema was significantly accelerated in the HA-SSD group · The product is a safe, well tolerated topical medication, both at the systemic and the local level. · Important adverse effects did not occur during the study · The principal biochemical, serological, and hematological values were not altered by topical application of the product. · Due to its favourable antibacterial, anti-edematous and analgesic effects along with a proven re-epithelialization fostering activity, the tested cream formulation with silver sulfadiazine and hyaluronic acid may enrich significantly the assortment of topical medications for treatment of burns and skin defects of other origin.
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