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The purpose of this study is to determine if the use of HemCon chitosan-based dressings is effective to facilitate safe, effective debridement of chronic wounds in the operating room and inpatient ward settings and to minimize bacterial re-colonization of wounds.
Full description
Primary objective: There are two primary objectives:
To demonstrate that debridements performed using HemCon dressings at the bedside can be performed safely without excessive bleeding in eligible patients To compare the levels of bacterial load between debrided wounds treated with HemCon dressings and debrided wounds treated with gauze and saline dressings at 2 days and 5 days after debridement
Secondary objectives: The following secondary objectives will be achieved by this study:
To determine the cost efficacy, if any, between wounds debrided at the bedside with HemCon dressings and wounds debrided in the operating room setting To determine the cost efficacy, if any, between wounds debrided in the operating room where hemostasis is achieved with a HemCon dressing and between debrided wounds where hemostasis is achieved with traditional cauterization methods. To compare comfort levels in patients treated with HemCon dressings as compared to traditional gauze dressings.
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Inclusion criteria
For subjects that are to undergo a debridement in the operating room:
For subjects that are to undergo a debridement in the bedside setting:
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37 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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