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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.
Primary objective: There are two primary objectives:
1. To demonstrate that debridements performed using HemCon dressings at the bedside can be performed safely without excessive bleeding in eligible patients
2. 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:
1. To determine the cost efficacy, if any, between wounds debrided at the bedside with HemCon dressings and wounds debrided in the operating room setting
2. 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.
3. To compare comfort levels in patients treated with HemCon dressings as compared to traditional gauze dressings.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
HemCon Dressings and HemCon ChitoGauze; chitosan-based., HemCon Dressings and HemCon ChitoGauze; chitosan-based., Gauze and saline dressings., Gauze and saline dressings.
HemCon Medical Technologies, Inc
Published on BioPortfolio: 2014-07-23T21:11:20-0400
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