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

NCT ID: NCT01035944

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HemCon Dressings and HemCon ChitoGauze; chitosan-based.

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Gauze and saline dressings.

Intervention Type: DEVICE

Control for both settings will be gauze and saline dressings.

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.

Group Type: EXPERIMENTAL

HemCon Dressings and HemCon ChitoGauze; chitosan-based.

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Gauze and saline dressings.

Intervention Type: DEVICE

Control for both settings will be gauze and saline dressings.

Interventions

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.

Intervention Type: DEVICE

Gauze and saline dressings.

Control for both settings will be gauze and saline dressings.

Intervention Type: DEVICE

Other Intervention Names

HemCon Dressings, HemCon ChitoGauze.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HemCon Medical Technologies, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D. Galiano, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital, Division of Plastic Surgery

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

HC-NU-2009-01

Identifier Type: -

Identifier Source: org_study_id