A prospective, randomized, controlled, double-masked, multi-center clinical trial of medical adhesives for the closure of laparoscopic incisions
JournalJournal of minimally invasive gynecology
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
MetadataShow full item record
STUDY OBJECTIVE: To compare LiquiBand Surgical S (LB) (Advanced Medical Solutions Ltd, Plymouth, UK) with High Viscosity Dermabond (DB) (Ethicon Inc., Kirkland, Scotland) for the closure of laparoscopic wounds. DESIGN: Prospective, multicenter, randomized, controlled trial (Canadian Task Force classification I). SETTING: Multiple district hospitals. PARTICIPANTS: A total of 433 subjects were enrolled between 2006 and 2009 at 4 investigational sites. INTERVENTIONS: In this study, LB, an octyl/butyl cyanoacrylate blend, and DB, an octyl-based cyanoacrylate, were compared for topical skin closure of laparoscopic port sites (www.clinicaltrials.gov; study identifier NCT00762905). MAIN RESULTS: High dermal apposition and cosmesis scores resulted from the use of both adhesives along with low rates of wound dehiscence and suspected infections. Masked evaluators and patients favored DB in the healing of the incisions (98.3% DB vs 93.9% LB, p < .05) and (97.2% DB vs 89.4% LB, p < .05). However, there was no difference in the overall satisfaction of the appearance of the wounds. LB was found to be significantly (p < .05) faster (LB = 32.1 seconds; DB, 50.3 seconds) and easier to use than DB, and surgical users were significantly more satisfied with using LB for wound closure. CONCLUSION: The results of this trial show the efficacy of LB for the closure of topical skin incisions; LB was significantly faster, easier to use, and resulted in greater user satisfaction compared with DB.