NCT02492048

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

July 1, 2015

Last Update Submit

March 13, 2018

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Healing at Donor Site

    8 weeks

  • Scarring

    8 weeks

  • Complications

    8 weeks

Study Arms (2)

Split Thickness Skin Graft Harvest

ACTIVE COMPARATOR

Retrospective review

Procedure: Split Thickness Skin Graft

Cellutome Epidermal Harvesting System

EXPERIMENTAL

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

Device: Cellutome Epidermal Harvesting System

Interventions

Cellutome Epidermal Harvesting SystemDEVICE

Cellutome Epidermal Harvesting System

Cellutome Epidermal Harvesting System
Split Thickness Skin GraftPROCEDURE

Split Thickness Skin Graft

Split Thickness Skin Graft Harvest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Noman A Siddiqui, DPM, MHA

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 8, 2015

Study Start

December 16, 2014

Primary Completion

November 22, 2016

Study Completion

December 1, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

US(1)