Wound DebridementNCT01035944
Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization
A study testing HemCon Dressings and HemCon ChitoGauze; chitosan-based. and Gauze and saline dressings. in people with Wound Debridement, run by HemCon Medical Technologies, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Debridement
- What is being tested?
- HemCon Dressings and HemCon ChitoGauze; chitosan-based. and Gauze and saline dressings.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Wound Debridement
- Being tested
- HemCon Dressings and HemCon ChitoGauze; chitosan-based., Gauze and saline dressings.
- Keywords
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.Device
Also called HemCon Dressings, HemCon ChitoGauze.
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.
Gauze and saline dressings.Device
Control for both settings will be gauze and saline dressings.
| Study group | Role | What they receive |
|---|---|---|
| HemCon Operating Room | Experimental | 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. Receives: Device: HemCon Dressings and HemCon ChitoGauze; chitosan-based. |
| Control Operating Room | Active comparator | 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. Receives: Device: Gauze and saline dressings. |
| HemCon Bedside | Experimental | 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. Receives: Device: HemCon Dressings and HemCon ChitoGauze; chitosan-based. |
| Control Bedside. | Active comparator | 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. Receives: Device: Gauze and saline dressings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days and 5 days after debridement.
Secondary outcomes (1)
Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting.
Measured: 2 days and 5 days after debridement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Unable to meet enrollment milestones
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound DebridementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemCon Medical Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert D. Galiano, M.D., Principal investigator, Northwestern Memorial Hospital, Division of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035944
- Sponsor's protocol ID
- HC-NU-2009-01
- Status last verified
- May 2014
- First submitted
- 17 Dec 2009
- Last updated
- 1 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01035944
- Acronym / sponsor ID
- HC-NU-2009-01
- Conditions
- Wound Debridement
- Keywords
- Chronic wounds, Chronic wound debridement, Debridement, Bedside debridement, Surgical debridement, Wound debridement, Minimize bacterial re-colonization of wounds, HemCon ChitoGauze Dressings
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment milestones
- Enrolment
- 37 participants (actual)
- Lead sponsor
- HemCon Medical Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HemCon Operating Room | Experimental | Device: HemCon Dressings and HemCon ChitoGauze; chitosan-based.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. |
| Control Operating Room | Active comparator | Device: 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. |
| HemCon Bedside | Experimental | Device: HemCon Dressings and HemCon ChitoGauze; chitosan-based.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. |
| Control Bedside. | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemCon Dressings and HemCon ChitoGauze; chitosan-based.Also: HemCon Dressings, HemCon ChitoGauze.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 | HemCon Bedside, HemCon Operating Room |
| Gauze and saline dressings.Control for both settings will be gauze and saline dressings. | Device | Control Bedside., Control Operating Room |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Galiano, M.D. principal investigator
Northwestern Memorial Hospital, Division of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemCon Dressings and HemCon ChitoGauze; chitosan-based. and Gauze and saline dressings. in people with Wound Debridement, run by HemCon Medical Technologies, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.