Application of Cultured Autologous Keratinocytes for Burn Wound Healing (KC)

February 13, 2020 updated by: Association of Dutch Burn Centres

Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The standard treatment for extensive burn wounds is transplantation with meshed split skin graft. Disadvantages of this treatment are that healing of large full thickness burn wounds is still accompanied by scar formation. Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure and improve outcome of healing.

Primary objective: Does the application of cultured autologous keratinocytes on deep burn wounds accelerate wound closure Secondary objectives: Does the application of cultured autologous keratinocytes on deep burn wounds improve scar quality with respect to scar elasticity, colour/pigmentation and/or smoothness after 3 and 12 months.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Beverwijk, Noord-Holland, Netherlands, 1942 LE
        • Red Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
wound 1: the placement of keratinocytes onto a collagen/elastin support after the application of the meshed split skin autograft.
Biological: Cultured autologous keratinocytes
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.
Other Names:
  • Cultured keratinocytes
Other: 2
control wound site; application of mesh graft alone
Biological: Cultured autologous keratinocytes
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.
Other Names:
  • Cultured keratinocytes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary end point is the percentage of wound closure.
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary objective is scar quality (i.e. subjective scar assessment, scar elasticity, colour and pigmentation of the scar and smoothness of the scar surface).
Time Frame: 3 and 12 months
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Dutch Burn Centres

Investigators

  • Study Director: E Middelkoop, Prof, Association of Dutch Burn Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBS 07.116 KC
  • NL19048.000.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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