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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
  Purpose

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 Intervention Phase
Burns
Burn Scars
Congenital Giant Nevi
 Device: Autologous engineered skin substitutes
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Engineered Skin Substitutes for Closure of Burn Wounds

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 144
Study Start Date: February 1998
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591513

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

No publications provided

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
Study First Received: December 27, 2007
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Burns
Nevus
Cicatrix
Wounds and Injuries
Nevi and Melanomas
 Neoplasms by Histologic Type
Neoplasms
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013