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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-16

Study Completion Date

2018-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Wounds and Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Split Thickness Skin Graft Harvest

Retrospective review

Group Type ACTIVE_COMPARATOR

Split Thickness Skin Graft

Intervention Type PROCEDURE

Split Thickness Skin Graft

Cellutome Epidermal Harvesting System

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

Group Type EXPERIMENTAL

Cellutome Epidermal Harvesting System

Intervention Type DEVICE

Cellutome Epidermal Harvesting System

Interventions

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Cellutome Epidermal Harvesting System

Intervention Type DEVICE

Split Thickness Skin Graft

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No