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Autologous Engineered Skin Substitutes for Closure of Skin Wounds

This study has suspended participant recruitment.
(The study is under hold. Collection of AEs continues.)
Sponsor:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00591513
First received: December 27, 2007
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

December 27, 2007
February 5, 2013
February 1998
December 2013   (final data collection date for primary outcome measure)
The ratio of closed wound area to donor skin area for engineered skin substitutes compared to meshed, split-thickness skin autograft. [ Time Frame: Post-operative day 28+/-3 ] [ Designated as safety issue: Yes ]
The ratio of closed wound area to donor skin area for engineered skin substitutes compared to meshed, split-thickness skin autograft. [ Time Frame: Post-operative day 28+/-7 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00591513 on ClinicalTrials.gov Archive Site
Qualitative outcome of scar formation of engineered skin substitutes or meshed, split-thickness skin autograft by the Vancouver Scar Scale which evaluates erythema (redness), pigmentation (color), pliability (softness), and scar height (smoothness). [ Time Frame: Post operative days 28+/-3 and 365+/-30 ] [ Designated as safety issue: No ]
Qualitative outcome of scar formation of engineered skin substitutes or meshed, split-thickness skin autograft by the Vancouver Scar Scale which evaluates erythema (redness), pigmentation (color), pliability (softness), and scar height (smoothness). [ Time Frame: Post operative days 28+/-7 and 365+/-90 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Autologous Engineered Skin Substitutes for Closure of Skin Wounds
Autologous Engineered Skin Substitutes for Closure of Burn Wounds

This clinical trial tests the hypothesis that engineered human skin can reduce the requirements for harvesting of conventional skin autografts by providing more skin for grafting from the donor skin used to treat the wounds. In life-threatening burns (e.g., greater than 50% of the total body surface area), greater availability of skin may be definitive to patient survival, and may reduce scar formation at the donor site, and from use of widely-meshed skin autograft.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Burns
  • Burn Scars
  • Congenital Giant Nevi
Device: Autologous engineered skin substitutes
Autologous skin cells combined with a biopolymer sponge which is transplanted to excised, full-thickness burns, excised or incised burn scars, or excised full-thickness congenital giant melanocytic nevus. Repeated administrations until all skin wounds are closed.
Other Name: Autologous Cultured Skin Substitutes
  • Active Comparator: Acute burn wounds
    Comparative grafting of acute burn wounds with autologous engineered skin and meshed, split-thickness autograft skin.
    Intervention: Device: Autologous engineered skin substitutes
  • Experimental: 2
    Reconstruction of burn scars.
    Intervention: Device: Autologous engineered skin substitutes
  • Active Comparator: 3
    Congenital, giant melanocytic nevus.
    Intervention: Device: Autologous engineered skin substitutes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
144
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Burns greater than 50% of the total body surface area (TBSA), including 10% TBSA full-thickness injury
  • Subject is not septic
  • Skin grafting expected after 3 weeks following the skin biopsy
  • Informed Consent signed.

Exclusion Criteria:

  • Subject is pregnant or lactating
  • Subject is a prisoner
  • Subject is mentally incompetent
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00591513
FD-R-672, FD-R-672, NIH-RO1-GM50509
Not Provided
University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Richard Kagan, MD Faculty
University of Cincinnati
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP