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Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients

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ClinicalTrials.gov Identifier: NCT02492048
Recruitment Status : Withdrawn
First Posted : July 8, 2015
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
LifeBridge Health

Brief Summary:
This is multi-center prospective, longitudinal case series with comparison to historical controls.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Device: Cellutome Epidermal Harvesting System Procedure: Split Thickness Skin Graft Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients
Actual Study Start Date : December 16, 2014
Actual Primary Completion Date : November 22, 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Split Thickness Skin Graft Harvest
Retrospective review
Procedure: Split Thickness Skin Graft
Split Thickness Skin Graft

Experimental: Cellutome Epidermal Harvesting System
Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System
Device: Cellutome Epidermal Harvesting System
Cellutome Epidermal Harvesting System




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Healing at Donor Site [ Time Frame: 8 weeks ]
    Photography and physician examination with determination

  2. Scarring [ Time Frame: 8 weeks ]
    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.

  3. Complications [ Time Frame: 8 weeks ]
    Cellulitis involving the donor or recipient site, infection involving continuous drainage, abscess formation, erythema, edema, pruritus and fever. Physician determination of complications post procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492048


Locations
United States, Maryland
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
LifeBridge Health
Kinetic Concepts, Inc.
Investigators
Principal Investigator: Noman A Siddiqui, DPM, MHA Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Responsible Party: LifeBridge Health
ClinicalTrials.gov Identifier: NCT02492048     History of Changes
Other Study ID Numbers: 2199
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries