NCT00832156

Brief Summary

In this study the treatment of full thickness burn wounds with cultured autologous keratinocytes in combination with meshed split skin autograft versus meshed split skin graft alone will be compared. It is expected that the application of cultured autologous keratinocytes in combination with a meshed split skin autograft will improve wound healing and scar formation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 17, 2020

Status Verified

June 1, 2014

Enrollment Period

4.3 years

First QC Date

January 28, 2009

Last Update Submit

February 13, 2020

Conditions

Burns

Keywords

BurnsCultured autologous keratinocytesWound healingWound closureScar quality

Outcome Measures

Primary Outcomes (1)

  • Primary end point is the percentage of wound closure.

    7 days

Secondary Outcomes (1)

  • Secondary objective is scar quality (i.e. subjective scar assessment, scar elasticity, colour and pigmentation of the scar and smoothness of the scar surface).

    3 and 12 months

Study Arms (2)

1

EXPERIMENTAL

wound 1: the placement of keratinocytes onto a collagen/elastin support after the application of the meshed split skin autograft.

Biological: Cultured autologous keratinocytes

2

OTHER

control wound site; application of mesh graft alone

Biological: Cultured autologous keratinocytes

Interventions

Cultured autologous keratinocytesBIOLOGICAL

The experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone.

Also known as: Cultured keratinocytes
12

Eligibility Criteria

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

You may qualify if:

  • Competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision
  • Minimal study wound area 100 cm2
  • Maximal study wound area 300 cm2
  • Maximal TBSA 30% full thickness wounds
  • Informed consent

You may not qualify if:

  • Immunocompromised patients
  • Infected wounds
  • Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica
  • Known penicillin allergy
  • Conditions where the patient is non compliant as judged by a medical specialist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • E Middelkoop, Prof

    Association of Dutch Burn Centers

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

June 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

February 17, 2020

Record last verified: 2014-06

Locations

NL(1)