NCT02089490 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chaouat M, Zakine G, Mimoun M
[Principles of the local treatment: Surgical processing]. Pathol Biol (Paris). 2011 Jun;59(3):e57-61. doi: 10.1016/j.patbio.2009.12.003. Epub 2010 Feb 8. Review. French.
Clark RA, Ghosh K, Tonnesen MG
Tissue engineering for cutaneous wounds. J Invest Dermatol. 2007 May;127(5):1018-29. Review.
Koenen W, Felcht M, Goerdt S, Faulhaber J
Skin substitutes in dermatosurgery. G Ital Dermatol Venereol. 2010 Oct;145(5):637-49.
MacNeil S
Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. Review.
Pham C, Greenwood J, Cleland H, Woodruff P, Maddern G
Bioengineered skin substitutes for the management of burns: a systematic review. Burns. 2007 Dec;33(8):946-57. Epub 2007 Sep 7. Review.
Shevchenko RV, James SL, James SE
A review of tissue-engineered skin bioconstructs available for skin reconstruction. J R Soc Interface. 2010 Feb 6;7(43):229-58. doi: 10.1098/rsif.2009.0403. Epub 2009 Oct 28. Review.

Prospective Follow-up Study for the Evaluation of the Safety and Efficacy of the Dermal Substitute NEVELIA® in the Treatment of Third-degree Burns and Reconstructive Surgery

Details for clinical trial NCT02089490

Clinical trial NCT02089490 - References