NCT01918059 - 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)

Gilbert L, Pogorzalek N, Jounda G, Barreau E
[Traumatic peri-ocular injuries: closing wounds using 2-octyl-cyanoacrylate medical glue]. J Fr Ophtalmol. 2009 May;32(5):341-7. doi: 10.1016/j.jfo.2009.03.024. Epub 2009 May 17. French.
Greene D, Koch RJ, Goode RL
Efficacy of octyl-2-cyanoacrylate tissue glue in blepharoplasty. A prospective controlled study of wound-healing characteristics. Arch Facial Plast Surg. 1999 Oct-Dec;1(4):292-6.
Handschel JG, Depprich RA, Dirksen D, Runte C, Zimmermann A, Kübler NR
A prospective comparison of octyl-2-cyanoacrylate and suture in standardized facial wounds. Int J Oral Maxillofac Surg. 2006 Apr;35(4):318-23. Epub 2005 Dec 20.
Hollander JE, Singer AJ, Valentine S, Henry MC
Wound registry: development and validation. Ann Emerg Med. 1995 May;25(5):675-85. Erratum in: Ann Emerg Med 1995 Oct;26(4):532.
Quinn JV, Drzewiecki AE, Stiell IG, Elmslie TJ
Appearance scales to measure cosmetic outcomes of healed lacerations. Am J Emerg Med. 1995 Mar;13(2):229-31.
Shivamurthy DM, Singh S, Reddy S
Comparison of octyl-2-cyanoacrylate and conventional sutures in facial skin closure. Natl J Maxillofac Surg. 2010 Jan;1(1):15-9. doi: 10.4103/0975-5950.69151.
Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE
Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-7.

Prospective, Randomized, Controlled Trial of Tissue Adhesive (Octyl-2-Cyanoacrylate) vs. Traditional Suture in Traumatic Lid Laceration Repair

Clinical trial NCT01918059 - References