Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors
Condition: Skin Closure of Surgical Incisions by Tissue Glue vs Suture
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Skin wound closure by tissue glue; Skin wound closure by conventional suture + dressing
Intervention type(s): Procedure; Procedure
Intervention description(s): The glue is used both as closure device and as wound dressing.; Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
Other intervention name(s): CE-marked Liquiband Laparoscopic/Surgical: CE 0123
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tissue glue; Cyanoacrylate; Wound closure; Living donor nephrectomy; Surgical wound closure