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

Not Applicable

Withdrawn

• Conditions: Wounds and Injuries
• Interventions: Procedure: Split Thickness Skin Graft; Device: Cellutome Epidermal Harvesting System

• Registration Number: NCT02492048
• Lead Sponsor: LifeBridge Health

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.

Study Timeline

• Study Start: 2014-12-16
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Primary Completion: 2016-11-22
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Split Thickness Skin Graft Harvest	Split Thickness Skin Graft	Retrospective review
Cellutome Epidermal Harvesting System	Cellutome Epidermal Harvesting System	Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System

Primary Outcome Measures

Name	Time	Method
Healing Time	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

Name	Time	Method
Scarring	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.
Healing at Donor Site	8 weeks	Photography and physician examination with determination
Complications	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.

Trial Locations

Locations (1)

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health; 🇺🇸 Baltimore, Maryland, United States