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

N/AWithdrawnNCT02492048

LifeBridge Health

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Wounds and Injuries

Interventions

Cellutome Epidermal Harvesting SystemDEVICE

Cellutome Epidermal Harvesting System

Split Thickness Skin GraftPROCEDURE

Split Thickness Skin Graft

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

Secondary Outcomes

Healing at Donor Site

Photography and physician examination with determination

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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