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.

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.

Study Overview

• Status: Terminated
• Conditions: Wound Debridement
• Intervention / Treatment: Device: HemCon Dressings and HemCon ChitoGauze; chitosan-based.; Device: Gauze and saline dressings.

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years and are able to provide written informed consent.
• Have a wound on their body with an eschar and/or significant slough present
• Documented laboratory studies and coagulation profiles prior to the debridement (including hematocrit, hemoglobin, white blood count, total lymphocyte count, albumin, pre-albumin, HbA1C in patients with diabetes)
• Subjects with a hemoglobin < 9 g/dL must have one unit of blood typed and cross matched prior to the debridement; all other subjects must have an active type and screen performed prior to the debridement procedure.
• Subjects must be willing to consent to a blood transfusion in the rare event that a transfusion is necessary.
• Must be expected to be inpatients for at least 5 days following debridement, to enable controlled dressing changes by the service.
• Female subjects of childbearing age must not be pregnant, and must consent to utilize an appropriate method of contraception during the course of the study.

For subjects that are to undergo a debridement in the operating room:

• Subjects must be sensate or have wounds that are sufficiently large to warrant a debridement in the OR
• Wounds must require more than a simple eschar removal, or must be extensive enough that an operating room debridement would be more appropriate.
• Subjects must be candidates for regional or general anesthesia, unless the wound occurs in an insensate body part (for example, a pressure sore in a paraplegic or quadriplegic patient, or a diabetic foot ulcer in a patient with a dense diabetic polyneuropathy).

For subjects that are to undergo a debridement in the bedside setting:

• The part of the wound that is to be debrided must be mostly an eschar and necrotic tissue which is not likely to have significant bleeding.
• Subjects must be insensate, or the wound must be less than 50 cm2 such that the use of local anesthesia in the wound can be undertaken.

Exclusion Criteria:

• Pre-debridement hemoglobin level < 7.0 g/dL
• Not candidates for or refuse blood transfusions
• Unable to provide written informed consent
• Subjects with sensitivity to chitosan or the gauze dressings used in this study, or any local anesthetic needed for a debridement
• Subjects who are in the intensive care unit
• Subjects who, in the opinion of the Investigator, may not complete the study for any reason.
• Have grossly infected wounds that may reasonably be expected to require multiple debridement procedures prior to clearance of bacteria and nonviable tissue from the wound.
• For wounds situated in the lower extremity, leg must have either palpable pulses or else an ABI > 0.4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HemCon Operating Room; The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.	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.; Other Names: HemCon Dressings, HemCon ChitoGauze.
Active Comparator: Control Operating Room; The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.	Device: Gauze and saline dressings.; Control for both settings will be gauze and saline dressings.
Experimental: HemCon Bedside; The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.	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.; Other Names: HemCon Dressings, HemCon ChitoGauze.
Active Comparator: Control Bedside.; The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.	Device: Gauze and saline dressings.; Control for both settings will be gauze and saline dressings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Demonstrate That Debridements Using HemCon Dressings at Bedside Can be Performed Safely Without Excessive Bleeding; Compare Levels of Bacterial Load Between Debrided Wounds Treated With HemCon Dressings vs. Wounds Treated With Gauze & Saline Dressings.	2 days and 5 days after debridement.

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting.	2 days and 5 days after debridement.

Collaborators and Investigators

• Sponsor: HemCon Medical Technologies, Inc
• Investigators: Principal Investigator: Robert D. Galiano, M.D., Northwestern Memorial Hospital, Division of Plastic Surgery

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 17, 2009
• First Submitted That Met QC Criteria: December 17, 2009
• First Posted (Estimate): December 21, 2009

Study Record Updates

• Last Update Posted (Estimate): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Debridement; Chronic wounds; Surgical debridement; Chronic wound debridement; Bedside debridement; Wound debridement; Minimize bacterial re-colonization of wounds; HemCon ChitoGauze Dressings; HemCon Dressings; Chitosan-based dressings
• Additional Relevant MeSH Terms: Wounds and Injuries; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: HC-NU-2009-01