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

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

Study Overview

• Status: Withdrawn
• Conditions: Wounds and Injuries
• Intervention / Treatment: Procedure: Split Thickness Skin Graft; Device: Cellutome Epidermal Harvesting System

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing at Donor Site	Photography and physician examination with determination	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.	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.	8 weeks

Collaborators and Investigators

• Sponsor: LifeBridge Health
• Collaborators: Kinetic Concepts, Inc.
• Investigators: Principal Investigator: Noman A Siddiqui, DPM, MHA, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2014
• Primary Completion (Actual): November 22, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes