Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors (TG-CYANO)

A Prospective, Randomised Study on Tissue Glue (Cyanoacrylate) Versus Conventional Suture for Skin Closure in Laparoscopic Living Donor Nephrectomy

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.

Study Overview

• Status: Completed
• Conditions: Skin Closure of Surgical Incisions by Tissue Glue vs Suture
• Intervention / Treatment: Procedure: Skin wound closure by tissue glue; Procedure: Skin wound closure by conventional suture + dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0027
    • Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tissue glue wound closure; Skin wound closure by tissue glue	Procedure: Skin wound closure by tissue glue; The glue is used both as closure device and as wound dressing.; Other Names: CE-marked Liquiband Laparoscopic/Surgical: CE 0123
Active Comparator: Conventional suture + dressing; Skin wound closure by conventional suture + dressing	Procedure: Skin wound closure by conventional suture + dressing; Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing by Numerical Scales for Rubor Postoperative Day 2.	The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At postoperative day 2 (2 days after kidney donation)
Wound Healing by Numerical Scales for Rubor Postoperative Day 4.	The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At postop. day 4 (4 days after kidney donation)
Wound Healing by Numerical Scales for Rubor at Discharge From Hospital.	The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
Wound Healing by Numerical Scales for Secretion Postoperative Day 2.	The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	Postop. day 2
Wound Healing by Numerical Scales for Secretion Postoperative Day 4.	The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	Postop. day 4
Wound Healing by Numerical Scales for Secretion at Discharge From Hospital.	The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
Wound Healing by Numerical Scales for Oedema Postoperative Day 2.	The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	Postop. day 2
Wound Healing by Numerical Scales for Oedema Postoperative Day 4.	The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	Postop. day 4
Wound Healing by Numerical Scales for Oedema at Discharge From Hospital.	The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
Wound Healing by Numerical Scales for Blisters Postoperative Day 2.	The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At postop. day 2 (2 days after kidney donation)
Wound Healing by Numerical Scales for Blisters Postoperative Day 4.	The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At postop. day 4 (4 days after kidney donation)
Wound Healing by Numerical Scales for Blisters at Discharge From Hospital.	The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
Wound Healing by Numerical Scales for Gaps Postoperative Day 2.	The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	Postop. day 2
Wound Healing by Numerical Scales for Gaps Postoperative Day 4.	The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	Postop. day 4
Wound Healing by Numerical Scales for Gaps at Discharge From Hospital.	The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.	At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
TIme Consumption	The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.	The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.
Patients´Self Satisfaction.	The patients' self-satisfaction was evaluated by means of a questionnaire rating the following 3 domains on a numerical (1-5) scale: Total satisfaction regarding wound healing/wound care. 1 (satisfied) to 5 (dissatisfied); Satisfaction regarding wound discomfort; pain, itching, paresthesia, pressure etc. 1 (almost no discomfort) to 5 (lot of discomfort); Satisfaction regarding wound care; suppleness, practicability versus mobilization, showering etc. 1 (almost no practical challenges) to 5 (lot of practical challenges) Patients' Self Satisfaction score was the sum of three domains, ranges from 3 (completely satisfied) to 15 (completely dissatisfied). These data were collected at the day of discharge, with guidance from two interviewers.	These data were collected at the day of discharge from hospital (postoperative day 4-8).

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Ole M Øyen, MD, PhD, Oslo University Hospital; Study Chair: Morten Skauby, MD, Oslo University Hospital

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Estimate): November 4, 2014
• Last Update Submitted That Met QC Criteria: November 3, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Tissue glue; Cyanoacrylate; Wound closure; Living donor nephrectomy; Surgical wound closure
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 214603

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No