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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02492048
• Other study ID #: 2199
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2015
• Last updated: March 13, 2018
• Start date: December 16, 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: LifeBridge Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Device:
• Cellutome Epidermal Harvesting System
Cellutome Epidermal Harvesting System

Procedure:
• Split Thickness Skin Graft
Split Thickness Skin Graft

Locations

Country	Name	City	State
United States	Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
LifeBridge Health	Kinetic Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Healing at Donor Site	Photography and physician examination with determination	8 weeks
Secondary	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
Secondary	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