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

This study has been terminated.
(Unable to meet enrollment milestones)
Sponsor:
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:
NCT01035944
First received: December 17, 2009
Last updated: June 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Wound Debridement
Device: HemCon Dressings and HemCon ChitoGauze; chitosan-based.
Device: Gauze and saline dressings.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 days and 5 days after debridement. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting. [ Time Frame: 2 days and 5 days after debridement. ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: 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 Name: 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.
Other Name: 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035944

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
HemCon Medical Technologies, Inc
Investigators
Principal Investigator: Robert D. Galiano, M.D. Northwestern Memorial Hospital, Division of Plastic Surgery
  More Information

No publications provided

Responsible Party: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT01035944     History of Changes
Other Study ID Numbers: HC-NU-2009-01
Study First Received: December 17, 2009
Results First Received: May 12, 2014
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by HemCon Medical Technologies, Inc:
Chronic wounds
Chronic wound debridement
Debridement
Bedside debridement
Surgical debridement
Wound debridement
Minimize bacterial re-colonization of wounds
HemCon ChitoGauze Dressings
HemCon Dressings
Chitosan-based dressings

Additional relevant MeSH terms:
Chitosan
Anticholesteremic Agents
Antimetabolites
Chelating Agents
Coagulants
Hematologic Agents
Hemostatics
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014