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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Association of Dutch Burn Centres.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT00832156
First received: January 28, 2009
Last updated: May 25, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Burns
 Biological: Cultured autologous keratinocytes
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:
  • Primary end point is the percentage of wound closure. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cultured keratinocytes
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 Name: Cultured keratinocytes

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832156

Contacts
Contact: M CT Bloemen, MD mbloemen@rkz.nl
Contact: M. Ulrich, PhD

Locations
Netherlands
Red Cross Hospital Recruiting
Beverwijk, Noord-Holland, Netherlands, 1942 LE
Principal Investigator: M CT Bloemen, MD            
Sponsors and Collaborators
Association of Dutch Burn Centres
Investigators
Study Director: E Middelkoop, Prof Association of Dutch Burn Centers
  More Information

No publications provided

Responsible Party: M.Bloemen/M.Ulrich, Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT00832156     History of Changes
Other Study ID Numbers: NBS 07.116 KC, NL19048.000.07
Study First Received: January 28, 2009
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Association of Dutch Burn Centres:
Burns
Cultured autologous keratinocytes
Wound healing
Wound closure
Scar quality

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013