Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary objective: There are two primary objectives:
-
To demonstrate that debridements performed using HemCon dressings at the bedside can be performed safely without excessive bleeding in eligible patients
-
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:
-
To determine the cost efficacy, if any, between wounds debrided at the bedside with HemCon dressings and wounds debrided in the operating room setting
-
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.
-
To compare comfort levels in patients treated with HemCon dressings as compared to traditional gauze dressings.
Study Design
Arms and Interventions
| 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:
|
| 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:
|
| 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.
|
Outcome Measures
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. [2 days and 5 days after debridement.]
Secondary Outcome Measures
- 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.]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HC-NU-2009-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | HemCon Operating Room | Control Operating Room | HemCon Bedside | Control Bedside. |
|---|---|---|---|---|
| Arm/Group Description | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. |
| Period Title: Overall Study | ||||
| STARTED | 14 | 14 | 5 | 4 |
| COMPLETED | 11 | 13 | 4 | 4 |
| NOT COMPLETED | 3 | 1 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | HemCon Operating Room | Control Operating Room | HemCon Bedside | Control Bedside. | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. | Total of all reporting groups |
| Overall Participants | 14 | 14 | 5 | 4 | 37 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
55.43
(20.0)
|
51.64
(16.2)
|
70.80
(19.9)
|
64.50
(20.8)
|
57.05
(19.1)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
10
71.4%
|
7
50%
|
2
40%
|
3
75%
|
22
59.5%
|
| Male |
4
28.6%
|
7
50%
|
3
60%
|
1
25%
|
15
40.5%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
14
100%
|
14
100%
|
5
100%
|
4
100%
|
37
100%
|
Outcome Measures
| Title | 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. |
|---|---|
| Description | |
| Time Frame | 2 days and 5 days after debridement. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participant data were analyzed. Study was terminated early; unable to reach enrollment milestones. |
| Arm/Group Title | HemCon Operating Room | Control Operating Room | HemCon Bedside | Control Bedside. |
|---|---|---|---|---|
| Arm/Group Description | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. |
| Measure Participants | 0 | 0 | 0 | 0 |
| Title | Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting. |
|---|---|
| Description | |
| Time Frame | 2 days and 5 days after debridement. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | HemCon Operating Room | Control Operating Room | HemCon Bedside | Control Bedside. | ||||
| Arm/Group Description | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. | 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. 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. | 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. Gauze and saline dressings.: Control for both settings will be gauze and saline dressings. | ||||
All Cause Mortality |
||||||||
| HemCon Operating Room | Control Operating Room | HemCon Bedside | Control Bedside. | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| HemCon Operating Room | Control Operating Room | HemCon Bedside | Control Bedside. | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/14 (0%) | 0/5 (0%) | 0/4 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| HemCon Operating Room | Control Operating Room | HemCon Bedside | Control Bedside. | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/14 (14.3%) | 1/14 (7.1%) | 1/5 (20%) | 2/4 (50%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anemia | 1/14 (7.1%) | 1 | 1/14 (7.1%) | 1 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| transfusion reaction | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Wound hematoma | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Infections and infestations | ||||||||
| Significant amount of bacteria in wound | 1/14 (7.1%) | 1 | 0/14 (0%) | 0 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Urinary tract infection | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Acute Pulmonary Embolism | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Bleeding Wound | 1/14 (7.1%) | 3 | 1/14 (7.1%) | 2 | 0/5 (0%) | 0 | 0/4 (0%) | 0 |
| Vascular disorders | ||||||||
| Acute Stroke | 0/14 (0%) | 0 | 0/14 (0%) | 0 | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Jody Oyama |
|---|---|
| Organization | HemCon Medical Technolgoies |
| Phone | 503.245.0459 |
| jody.oyama@hemcon.com |
- HC-NU-2009-01