NCT01035944

Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization

Evaluation of Use of Chitosan-Based Dressings to Facilitate Safe, Effective Debridement of Chronic Wounds in Operating Room and Inpatient Ward and Minimize Bacterial Re-Colonization of Wounds.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: HemCon Medical Technologies, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Wound Debridement

Interventions

Type	Name	Description
DEVICE	HemCon Dressings and HemCon ChitoGauze; chitosan-based.	Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
DEVICE	Gauze and saline dressings.	Control for both settings will be gauze and saline dressings.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-12-21
• Last updated: 2014-07-01
• Results posted: 2014-06-09

Locations

1 site across 1 country: United States