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Clinical Research
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RESULTS OF A MULTICENTRE RANDOMISED PROSPECTIVE OPEN LABEL PILOT STUDY TO EVALUATE A NEW SILVER ALGINATE ANTIMICROBIAL WOUND DRESSING ON CRITICALLY CO First Author: Richard Freeman Authors: PROF BEELE MR MEULENEIRE DR NAHUYS RESULTS OF A MULTICENTRE RANDOMISED PROSPECTIVE OPEN LABEL PILOT STUDY TO EVALUATE A NEW SILVER ALGINATE ANTIMICROBIAL WOUND DRESSING ON CRITICALLY COLONISED CHRONIC WOUNDS Introduction and Method The purpose of this study was to evaluate the safety and clinical performance of a new, silver containing, alginate wound dressing. The trial was conducted by Mediqol/PDMT Limited (UK and Netherlands), and was sponsored by Advanced Medical Solutions Limited (UK). The study was a multicentre randomised prospective open label pilot study with the aim of evaluating the performance, both in terms of its exudate management performance and its antimicrobial properties, of the new silver alginate wound dressing, for up to four weeks on critically colonised chronic wounds. Thirty six (36) patients were enrolled in this study, 18 treated with the new silver alginate wound dressing and 18 treated with the control. The control dressing used in the study was Kaltostat¨: a non silver-containing alginate wound dressing manufactured by ConvaTec (A Bristol-Myers Squibb Company). Primary Endpoints The dressings were applied to critically colonised chronic wounds and therefore at risk of infection. Both dressings were used for up to four weeks and an assessment made of their ability in preventing the occurrence of infection. The following endpoints were applied: • Modified ASEPSIS index • Medical evaluations: - amount of wound closure (healed, improved, stagnation, deterioration) - condition of surrounding skin - complete debridement of the wound achieved - reduction in wound odour - local haemostasis - intact dressing removal • Reduction in wound area during treatment Secondary Endpoints In addition, a number of secondary endpoints were also included to prove that the silver alginate dressing is safe and well tolerated, with no unanticipated adverse events: • Argyria/localised staining of skin • Drainage of abscess under local or general anaesthesia, • Debridement of wound under general anaesthesia, • Necessity to prescribe antibiotics and isolation of pathogen organisms. • Necessity of hospital admission in relation to target wound status Patient enrolment was conducted at three clinical sites by Prof. Beele, University Hospital, Gent (Belgium), Mr Meulineire, General Hospital, Zottegem (Belgium) and Dr Nahuys General Hospital, Amstelveen (Netherlands) and enrolment occurred between October 2005 and July 2006 The results of this multicentre randomised clinical trial will be presented in this poster. |
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