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

This study has been completed.
Sponsor:
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT00832156
First received: January 28, 2009
Last updated: June 11, 2014
Last verified: June 2014
  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:


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 ]

Enrollment: 40
Study Start Date: June 2008
Study Completion Date: September 2013
Primary Completion Date: September 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Red Cross Hospital
Beverwijk, Noord-Holland, Netherlands, 1942 LE
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: June 11, 2014
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 September 15, 2014