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

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Skin Closure of Surgical Incisions by Tissue Glue vs Suture

Treatments: Procedure: Skin wound closure by conventional suture + dressing; Procedure: Skin wound closure by tissue glue

Study type: Interventional

Funder types: Other

Identifiers

NCT01521871

214603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Tissue glue wound closure

Experimental group

Description:

Skin wound closure by tissue glue

Treatment:

Procedure: Skin wound closure by tissue glue

Conventional suture + dressing

Active Comparator group

Description:

Skin wound closure by conventional suture + dressing

Treatment:

Procedure: Skin wound closure by conventional suture + dressing