Status:
COMPLETED
Application of Cultured Autologous Keratinocytes for Burn Wound Healing
Lead Sponsor:
Association of Dutch Burn Centres
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. ...
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 accompan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00832156
Start Date
June 1 2008
End Date
September 1 2013
Last Update
February 17 2020
Active Locations (1)
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1
Red Cross Hospital
Beverwijk, North Holland, Netherlands, 1942 LE