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

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ClinicalTrials.gov Identifier: NCT00832156
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : June 12, 2014
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Burns Biological: Cultured autologous keratinocytes Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing
Study Start Date : June 2008
Primary Completion Date : September 2012
Study Completion Date : September 2013

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U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. Primary end point is the percentage of wound closure. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  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). [ Time Frame: 3 and 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014

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