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Autologous Engineered Skin Substitutes for Closure of Burn Wounds


Phase 2/Phase 3
N/A
75 Years
Not Enrolling
Both
Burns, Burn Scars, Congenital Giant Nevi

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Trial Information

Autologous Engineered Skin Substitutes for Closure of Burn Wounds


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The ratio of closed wound area to donor skin area for engineered skin substitutes compared to meshed, split-thickness skin autograft.

Outcome Time Frame:

Post-operative day 28+/-3

Safety Issue:

Yes

Principal Investigator

Richard Kagan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Faculty

Authority:

United States: Food and Drug Administration

Study ID:

FD-R-672

NCT ID:

NCT00591513

Start Date:

February 1998

Completion Date:

December 2013

Related Keywords:

  • Burns
  • Burn Scars
  • Congenital Giant Nevi
  • burns
  • burn scars
  • congenital giant nevi
  • Burns
  • Nevus
  • Cicatrix

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