Back to resultsEffectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
Primary Purpose
Wounds and Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cellutome Epidermal Harvesting System
Split Thickness Skin Graft
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Split Thickness Skin Graft Harvest
Cellutome Epidermal Harvesting System
Arm Description
Retrospective review
Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Healing at Donor Site
Photography and physician examination with determination
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.
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.
Full Information
NCT ID
NCT02492048
First Posted
July 1, 2015
Last Updated
March 13, 2018
Sponsor
LifeBridge Health
Collaborators
Kinetic Concepts, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02492048
Brief Title
Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
Official Title
Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
November 22, 2016 (Actual)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeBridge Health
Collaborators
Kinetic Concepts, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Split Thickness Skin Graft Harvest
Arm Type
Active Comparator
Arm Description
Retrospective review
Arm Title
Cellutome Epidermal Harvesting System
Arm Type
Experimental
Arm Description
Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System
Intervention Type
Device
Intervention Name(s)
Cellutome Epidermal Harvesting System
Intervention Description
Cellutome Epidermal Harvesting System
Intervention Type
Procedure
Intervention Name(s)
Split Thickness Skin Graft
Intervention Description
Split Thickness Skin Graft
Primary Outcome Measure Information:
Title
Healing Time
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Healing at Donor Site
Description
Photography and physician examination with determination
Time Frame
8 weeks
Title
Scarring
Description
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.
Time Frame
8 weeks
Title
Complications
Description
Cellulitis involving the donor or recipient site, infection involving continuous drainage, abscess formation, erythema, edema, pruritus and fever. Physician determination of complications post procedure.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noman A Siddiqui, DPM, MHA
Organizational Affiliation
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
We'll reach out to this number within 24 hrs