Wounds and InjuriesNCT02492048
Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
A study testing Cellutome Epidermal Harvesting System and Split Thickness Skin Graft in people with Wounds and Injuries, run by LifeBridge Health at 1 site in United States.
Trial summary
This is multi-center prospective, longitudinal case series with comparison to historical controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Cellutome Epidermal Harvesting System and Split Thickness Skin Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Signed Informed Consent
- Patients requiring split-thickness skin grafting with non-infected wounds
- Age of participants: 18 years and above at the time of informed consent
- Gender: Male or Female
- Subjects who will be locally available for the next 6 months.
Who cannot join
- Infected chronic wound
- Patients who are unable to adhere to scheduled study visits
- Patients who have severe arterial insufficiency requiring vascular intervention to restore adequate blood flow
- Patients who have an active drug/alcohol dependence or abuse history
- Use of Investigational Agents/Devices on study or within 30 days prior to informed consent or within 30 days prior to use of device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
Baltimore, Maryland, 21215
About this study
This is multi-center prospective, longitudinal case series with comparison to historical controls.
Read the detailed description
The primary objective to this study is to determine the effectiveness of CelluTome™ epidermal harvesting system as an outpatient skin grafting system for selected patients versus inpatient skin graft harvest. This is multi-center prospective, longitudinal case series with comparison to historical controls. In this study, all subjects will receive the same treatment protocol regardless of institution. This will include routine wound photography. Ongoing healing process will be recorded and reviewed. The secondary objectives of this study are to establish an ideal donor site size, recipient site size and ideal patient population (especially high operative risk patients) that would benefit from the use of CelluTome™ Epidermal Harvesting System.
- Conditions
- Wounds and Injuries
- Being tested
- Cellutome Epidermal Harvesting System, Split Thickness Skin Graft
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellutome Epidermal Harvesting SystemDevice
Cellutome Epidermal Harvesting System
Split Thickness Skin GraftProcedure or surgery
Split Thickness Skin Graft
| Study group | Role | What they receive |
|---|---|---|
| Split Thickness Skin Graft Harvest | Active comparator | Retrospective review Receives: Procedure: Split Thickness Skin Graft |
| Cellutome Epidermal Harvesting System | Experimental | Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System Receives: Device: Cellutome Epidermal Harvesting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Time
Healing time is defined as the required time for the graft site to become dry enough for removal of the dressing without further discharge from the wound AND 100% re-epithelialization has occurred
Measured: 8 weeks
Secondary outcomes (3)
Healing at Donor Site
Photography and physician examination with determination
Measured: 8 weeks
Scarring
Areas of donor site which heal with excess scar tissue and recipient site which heal due to secondary intention (epithelization without skin grafting application). Photography and physician examination with determination.
Measured: 8 weeks
Complications
Cellulitis involving the donor or recipient site, infection involving continuous drainage, abscess formation, erythema, edema, pruritus and fever. Physician determination of complications post procedure.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study start16 Dec 2014
- Primary completion22 Nov 2016
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor
- Investigators
- Noman A Siddiqui, DPM, MHA, Principal investigator, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492048
- Sponsor's protocol ID
- 2199
- Status last verified
- Mar 2018
- First submitted
- 1 Jul 2015
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
- ClinicalTrials.gov ID
- NCT02492048
- Acronym / sponsor ID
- 2199
- Conditions
- Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is multi-center prospective, longitudinal case series with comparison to historical controls.
Detailed description
The primary objective to this study is to determine the effectiveness of CelluTome™ epidermal harvesting system as an outpatient skin grafting system for selected patients versus inpatient skin graft harvest. This is multi-center prospective, longitudinal case series with comparison to historical controls. In this study, all subjects will receive the same treatment protocol regardless of institution. This will include routine wound photography. Ongoing healing process will be recorded and reviewed. The secondary objectives of this study are to establish an ideal donor site size, recipient site size and ideal patient population (especially high operative risk patients) that would benefit from the use of CelluTome™ Epidermal Harvesting System.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split Thickness Skin Graft Harvest | Active comparator | Procedure: Split Thickness Skin GraftRetrospective review |
| Cellutome Epidermal Harvesting System | Experimental | Device: Cellutome Epidermal Harvesting SystemProspective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- Patients requiring split-thickness skin grafting with non-infected wounds
- Age of participants: 18 years and above at the time of informed consent
- Gender: Male or Female
- Subjects who will be locally available for the next 6 months.
Key exclusion criteria (5 listed)
- Infected chronic wound
- Patients who are unable to adhere to scheduled study visits
- Patients who have severe arterial insufficiency requiring vascular intervention to restore adequate blood flow
- Patients who have an active drug/alcohol dependence or abuse history
- Use of Investigational Agents/Devices on study or within 30 days prior to informed consent or within 30 days prior to use of device.
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 |
|---|---|---|
| Cellutome Epidermal Harvesting SystemCellutome Epidermal Harvesting System | Device | Cellutome Epidermal Harvesting System |
| Split Thickness Skin GraftSplit Thickness Skin Graft | Procedure or surgery | Split Thickness Skin Graft Harvest |
Primary outcome
Healing Time
Time frame: 8 weeks
Healing time is defined as the required time for the graft site to become dry enough for removal of the dressing without further discharge from the wound AND 100% re-epithelialization has occurred
3 secondary outcomes
Healing at Donor Site
Time frame: 8 weeks
Scarring
Time frame: 8 weeks
Complications
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
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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.
Noman A Siddiqui, DPM, MHA principal investigator
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellutome Epidermal Harvesting System and Split Thickness Skin Graft in people with Wounds and Injuries, run by LifeBridge Health 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 15 Mar 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Healing Time (time frame: 8 weeks). 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 15 Mar 2018.