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


Phase 4
18 Years
90 Years
Open (Enrolling)
Both
Skin Closure of Surgical Incisions by Tissue Glue vs Suture

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Wound healing by numerical scales for secretion, gaps,edema and rubor.

Outcome Description:

Infection/bacteriology and complications/reinterventions will also be registered.

Outcome Time Frame:

At departure from hospital; usually 4, 5, 6 or 7 days after kidney donation.

Safety Issue:

No

Principal Investigator

Ole M Øyen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital, Rikshospitalet

Authority:

Norway:National Committee for Medical and Health Research Ethics

Study ID:

214603

NCT ID:

NCT01521871

Start Date:

January 2012

Completion Date:

February 2013

Related Keywords:

  • Skin Closure of Surgical Incisions by Tissue Glue vs Suture
  • Tissue glue
  • Cyanoacrylate
  • Wound closure
  • Living donor nephrectomy
  • Surgical wound closure

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