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

• ClinicalTrials.gov Identifier: NCT01521871
• Recruitment Status: Completed
• First Posted: January 31, 2012
• Results First Posted: November 4, 2014
• Last Update Posted: November 4, 2014
• Sponsor: Oslo University Hospital
• Information provided by (Responsible Party): Ole Morten Øyen, Oslo University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Skin Closure of Surgical Incisions by Tissue Glue vs Suture	Procedure: Skin wound closure by tissue glue; Procedure: Skin wound closure by conventional suture + dressing	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomised Study on Tissue Glue (Cyanoacrylate) Versus Conventional Suture for Skin Closure in Laparoscopic Living Donor Nephrectomy
• Study Start Date: January 2012
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: February 2013

Arms and Interventions

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 Name: 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)

Outcome Measures

Primary Outcome Measures :

1. Wound Healing by Numerical Scales for Rubor Postoperative Day 2. [ Time Frame: At postoperative day 2 (2 days after kidney donation) ]
   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.
2. Wound Healing by Numerical Scales for Rubor Postoperative Day 4. [ Time Frame: At postop. day 4 (4 days after kidney donation) ]
   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.
3. Wound Healing by Numerical Scales for Rubor at Discharge From Hospital. [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ]
   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.
4. Wound Healing by Numerical Scales for Secretion Postoperative Day 2. [ Time Frame: Postop. 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.
5. Wound Healing by Numerical Scales for Secretion Postoperative Day 4. [ Time Frame: Postop. 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.
6. Wound Healing by Numerical Scales for Secretion at Discharge From Hospital. [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ]
   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.
7. Wound Healing by Numerical Scales for Oedema Postoperative Day 2. [ Time Frame: Postop. 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.
8. Wound Healing by Numerical Scales for Oedema Postoperative Day 4. [ Time Frame: Postop. 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.
9. Wound Healing by Numerical Scales for Oedema at Discharge From Hospital. [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ]
   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.
10. Wound Healing by Numerical Scales for Blisters Postoperative Day 2. [ Time Frame: At postop. day 2 (2 days after kidney donation) ]
    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.
11. Wound Healing by Numerical Scales for Blisters Postoperative Day 4. [ Time Frame: At postop. day 4 (4 days after kidney donation) ]
    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.
12. Wound Healing by Numerical Scales for Blisters at Discharge From Hospital. [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ]
    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.
13. Wound Healing by Numerical Scales for Gaps Postoperative Day 2. [ Time Frame: Postop. 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.
14. Wound Healing by Numerical Scales for Gaps Postoperative Day 4. [ Time Frame: Postop. 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.
15. Wound Healing by Numerical Scales for Gaps at Discharge From Hospital. [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ]
    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.
16. TIme Consumption [ Time Frame: 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.
17. Patients´Self Satisfaction. [ Time Frame: These data were collected at the day of discharge from hospital (postoperative day 4-8). ]

    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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Norway

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

Oslo, Norway, 0027

Sponsors and Collaborators

Oslo University Hospital

Investigators

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

More Information

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.

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.

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;(3):CD003326. Review.

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. Review. Update in: Cochrane Database Syst Rev. 2014;11:CD004287.

Liversedge NH. Get Stuck In! Hands On Experiences With Surgical Skin Glue. Obs & Gynae Product News 2007; Issue 14: 24-28

• Responsible Party: Ole Morten Øyen, Principal Investigator, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01521871
• Other Study ID Numbers: 214603
• First Posted: January 31, 2012
• Results First Posted: November 4, 2014
• Last Update Posted: November 4, 2014
• Last Verified: November 2014

Keywords provided by Ole Morten Øyen, Oslo University Hospital:

Tissue glue; Cyanoacrylate; Wound closure; Living donor nephrectomy; Surgical wound closure

Additional relevant MeSH terms:

Surgical Wound; Wounds and Injuries