Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors
NCT ID: NCT01521871
Last Updated: 2014-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
64 participants
INTERVENTIONAL
2012-01-31
2013-02-28
Brief Summary
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Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least as good as conventional suture regarding wound healing/complications. (ii) Peroperatively, tissue glue is faster than conventional suture.
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Detailed Description
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The investigators consider use of tissue glue instead of suture as another small step towards less invasive surgery.
Since 2000 there has been many reports, and even Cochrane reviews on the use/safety of tissue glue for skin closure. However, very few randomised studies have been performed with the latest generation tissue glue; Cyanoacrylate, with a critical mixture of octyl-:butyl-acrylate. And in Norway there has been no research in this field.
On this basis, the investigators intend to examine skin closure in living donors, a very healthy/homogenous study population, subjected to laparoscopic, hand-assisted nephrectomy, by a prospective, randomised trial: Tissue glue (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1; 30 + 30 donors).
Primarily, the investigators will examine wound healing/complications by wound observation at postop. days 2 + 4 + 'at departure', with numerical scales for secretion, gaps, edema, rubor - as well as infection/bacteriology and complications/ reinterventions. In addition, the donors' self-satisfaction with the wound handling will be registered. Furthermore, the investigators will look at time consumption during surgery, price, stay in hospital and cosmesis judged at 2-3 months postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tissue glue wound closure
Skin wound closure by tissue glue
Skin wound closure by tissue glue
The glue is used both as closure device and as wound dressing.
Conventional suture + dressing
Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing
Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
Interventions
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Skin wound closure by tissue glue
The glue is used both as closure device and as wound dressing.
Skin wound closure by conventional suture + dressing
Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Approved comprehensive work-up/evaluation at local hospital
Exclusion Criteria
* Unable to communicate in norwegian language
18 Years
90 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Ole Morten Øyen
Principal Investigator
Principal Investigators
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Ole M Øyen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Morten Skauby, MD
Role: STUDY_CHAIR
Oslo University Hospital
Locations
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Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine
Oslo, Oslo County, Norway
Countries
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References
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Blondeel PN, Murphy JW, Debrosse D, Nix JC 3rd, Puls LE, Theodore N, Coulthard P. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods. Am J Surg. 2004 Sep;188(3):307-13. doi: 10.1016/j.amjsurg.2004.04.006.
Dowson CC, Gilliam AD, Speake WJ, Lobo DN, Beckingham IJ. A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures. Surg Laparosc Endosc Percutan Tech. 2006 Jun;16(3):146-50. doi: 10.1097/00129689-200606000-00005.
Farion K, Osmond MH, Hartling L, Russell K, Klassen T, Crumley E, Wiebe N. Tissue adhesives for traumatic lacerations in children and adults. Cochrane Database Syst Rev. 2002;2002(3):CD003326. doi: 10.1002/14651858.CD003326.
Coulthard P, Esposito M, Worthington HV, van der Elst M, van Waes OJ, Darcey J. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2010 May 12;(5):CD004287. doi: 10.1002/14651858.CD004287.pub3.
Liversedge NH. Get Stuck In! Hands On Experiences With Surgical Skin Glue. Obs & Gynae Product News 2007; Issue 14: 24-28
Other Identifiers
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214603
Identifier Type: -
Identifier Source: org_study_id
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