A Prospective, Randomised Study on Tissue Glue (Cyanoacrylate) Versus Conventional Suture for Skin Closure in Laparoscopic Living Donor Nephrectomy
At Oslo University Hospital Rikshospitalet, the proncipal 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Wound healing by numerical scales for secretion, gaps,edema and rubor.
Infection/bacteriology and complications/reinterventions will also be registered.
At departure from hospital; usually 4, 5, 6 or 7 days after kidney donation.
Ole M Øyen, MD, PhD
Oslo University Hospital, Rikshospitalet
Norway:National Committee for Medical and Health Research Ethics