A prospective, randomized, controlled, double-masked, multi-center clinical trial of medical adhesives for the closure of laparoscopic incisions

2.50
Hdl Handle:
http://hdl.handle.net/11287/593785
Title:
A prospective, randomized, controlled, double-masked, multi-center clinical trial of medical adhesives for the closure of laparoscopic incisions
Authors:
Kent, A.; Liversedge, Neil; Dobbins, B.; McWhinnie, D.; Jan, H.
Abstract:
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.
Citation:
J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):252-8.
Publisher:
Elsevier
Journal:
Journal of minimally invasive gynecology
Issue Date:
1-Mar-2014
URI:
http://hdl.handle.net/11287/593785
DOI:
10.1016/j.jmig.2013.10.003
PubMed ID:
24128996
Additional Links:
http://linkinghub.elsevier.com/retrieve/pii/S1553-4650(13)01291-0
Type:
Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Language:
eng
ISSN:
1553-4669
Appears in Collections:
2014 RD&E publications; Obstetrics, Gynaecology & Maternity Services

Full metadata record

DC FieldValue Language
dc.contributor.authorKent, A.en
dc.contributor.authorLiversedge, Neilen
dc.contributor.authorDobbins, B.en
dc.contributor.authorMcWhinnie, D.en
dc.contributor.authorJan, H.en
dc.date.accessioned2016-01-19T12:34:54Zen
dc.date.available2016-01-19T12:34:54Zen
dc.date.issued2014-03-01en
dc.identifier.citationJ Minim Invasive Gynecol. 2014 Mar-Apr;21(2):252-8.en
dc.identifier.issn1553-4669en
dc.identifier.pmid24128996en
dc.identifier.doi10.1016/j.jmig.2013.10.003en
dc.identifier.urihttp://hdl.handle.net/11287/593785en
dc.description.abstractSTUDY 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.en
dc.language.isoengen
dc.publisherElsevieren
dc.relation.urlhttp://linkinghub.elsevier.com/retrieve/pii/S1553-4650(13)01291-0en
dc.titleA prospective, randomized, controlled, double-masked, multi-center clinical trial of medical adhesives for the closure of laparoscopic incisionsen
dc.typeMulticenter Studyen
dc.typeRandomized Controlled Trialen
dc.typeResearch Support, Non-U.S. Gov'ten
dc.identifier.journalJournal of minimally invasive gynecologyen

Related articles on PubMed

All Items in RD&E Research Repository are protected by copyright, with all rights reserved, unless otherwise indicated.