Clinical trial NCT01521871: Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors
Official title: A Prospective, Randomised Study on Tissue Glue (Cyanoacrylate) Versus Conventional Suture for Skin Closure in Laparoscopic Living Donor Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Closure of Surgical Incisions by Tissue Glue vs Suture
Keywords: Tissue glue
Cyanoacrylate
Wound closure
Living donor nephrectomy
Surgical wound closure
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By means of a prospective, randomised trial the investigators want to examine skin closure in living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1; 30 + 30 donors).

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.

Detailed description: At Oslo University Hospital Rikshospitalet, the principal investigator have since 1998 been involved in developing minimally invasive techniques for living donor nephrectomy (LDN). Since 2009 all LDN's have been performed by laparoscopic, hand-assisted technique; by means of 'handport' and 3 laparoscopic ports (5/12 mm).

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.

Eligibility criteria: Inclusion Criteria:

* Living kidney donor with informed consent
* Approved comprehensive work-up/evaluation at local hospital

Exclusion Criteria:

* Allergy towards acrylate or similar chemicals
* Unable to communicate in norwegian language

Primary outcomes:
measure: Wound Healing by Numerical Scales for Rubor Postoperative Day 2.
timeFrame: At postoperative day 2 (2 days after kidney donation)
measure: Wound Healing by Numerical Scales for Rubor Postoperative Day 4.
timeFrame: At postop. day 4 (4 days after kidney donation)
measure: Wound Healing by Numerical Scales for Rubor at Discharge From Hospital.
timeFrame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
measure: Wound Healing by Numerical Scales for Secretion Postoperative Day 2.
timeFrame: Postop. day 2
measure: Wound Healing by Numerical Scales for Secretion Postoperative Day 4.
timeFrame: Postop. day 4
measure: Wound Healing by Numerical Scales for Secretion at Discharge From Hospital.
timeFrame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
measure: Wound Healing by Numerical Scales for Oedema Postoperative Day 2.
timeFrame: Postop. day 2
measure: Wound Healing by Numerical Scales for Oedema Postoperative Day 4.
timeFrame: Postop. day 4
measure: Wound Healing by Numerical Scales for Oedema at Discharge From Hospital.
timeFrame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
measure: Wound Healing by Numerical Scales for Blisters Postoperative Day 2.
timeFrame: At postop. day 2 (2 days after kidney donation)
measure: Wound Healing by Numerical Scales for Blisters Postoperative Day 4.
timeFrame: At postop. day 4 (4 days after kidney donation)
measure: Wound Healing by Numerical Scales for Blisters at Discharge From Hospital.
timeFrame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
measure: Wound Healing by Numerical Scales for Gaps Postoperative Day 2.
timeFrame: Postop. day 2
measure: Wound Healing by Numerical Scales for Gaps Postoperative Day 4.
timeFrame: Postop. day 4
measure: Wound Healing by Numerical Scales for Gaps at Discharge From Hospital.
timeFrame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
measure: TIme Consumption
timeFrame: The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.
measure: Patients´Self Satisfaction.
timeFrame: These data were collected at the day of discharge from hospital (postoperative day 4-8).
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine
Study officials:
affiliation: Oslo University Hospital
name: Ole M Øyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Morten Skauby, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Liversedge NH. Get Stuck In! Hands On Experiences With Surgical Skin Glue. Obs & Gynae Product News 2007; Issue 14: 24-28