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Autologous Engineered Skin Substitutes for Closure of Skin Wounds

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ClinicalTrials.gov Identifier: NCT00591513
Recruitment Status : Terminated
First Posted : January 11, 2008
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
University of Cincinnati

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Burns Burn Scars Congenital Giant Nevi Device: Autologous engineered skin substitutes Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Engineered Skin Substitutes for Closure of Burn Wounds
Study Start Date : February 1998
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acute burn wounds
Comparative grafting of acute burn wounds with autologous engineered skin and meshed, split-thickness autograft skin.
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

Experimental: 2
Reconstruction of burn scars.
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: 3
Congenital, giant melanocytic nevus.
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00591513


Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Richard Kagan, MD Faculty

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00591513     History of Changes
Obsolete Identifiers: NCT00004413
Other Study ID Numbers: FD-R-672
FD-R-672
NIH-RO1-GM50509
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015

Keywords provided by University of Cincinnati:
burns
burn scars
congenital giant nevi

Additional relevant MeSH terms:
Burns
Wounds and Injuries