Trial record 17 of 58 for:    "Living Donors" | Open Studies

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ole Morten Øyen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01521871
First received: January 12, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Wound healing by numerical scales for secretion, gaps,edema and rubor. [ Time Frame: At departure from hospital; usually 4, 5, 6 or 7 days after kidney donation. ] [ Designated as safety issue: No ]
    Infection/bacteriology and complications/reinterventions will also be registered.

  • Wound healing by numerical scales for secretion, gaps,edema and rubor. [ Time Frame: At postop. day 2 (2 days after kidney donation) ] [ Designated as safety issue: No ]
    Infection/bacteriology and complications/reinterventions will also be registered.

  • Wound healing by numerical scales for secretion, gaps,edema and rubor. [ Time Frame: At postop. day 4 (4 days after kidney donation) ] [ Designated as safety issue: No ]

    If the donor has departed from hospital at postop. day 4 or previously, this outcome will be left out.

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



Secondary Outcome Measures:
  • The donors' self-satisfaction with the wound handling, by numerical scales. [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ] [ Designated as safety issue: No ]
  • Time consumption for skin closure during surgery; tissue glue versus suture. [ Time Frame: Time consumption for skin closure is measured, assessed and recorded at the end of the operation ] [ Designated as safety issue: No ]

    Tissue glue: Time is measured from the start of gluing untill all wounds have been closed and also "bandaged" bye glue.

    Conventional suture: Time is measured from the start of the intracutaneous suture untill all wound have been dressed.

    The time consumption at this final part of the operation is assessed and recorded immediately.


  • Price; tissue glue versus suture + dressing [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ] [ Designated as safety issue: No ]
  • Cosmetic result by direct inspection and numerical scale rating [ Time Frame: 2-3 months postoperatively ] [ Designated as safety issue: No ]

    The numerical scale for cosmetic result will include these parameters: Scar width, scar prominence/height, bulges/assymetry around the scar and scar obscureness.

    Furthermore, photographs will be taken. We will then, optionally, have the opportunity for blinded cosmetic judgement by others. However, photographs are inferior to direct inspection regarding cosmetic result.


  • Stay in hospital [ Time Frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521871

Contacts
Contact: Ole M Øyen, MD, PhD +4723070686 ole.oyen@ous-hf.no
Contact: Morten Skauby, MD +472072265 morten.skauby@ous-hf.no

Locations
Norway
Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine Recruiting
Oslo, Norway, 0027
Contact: Ole M Øyen, MD, PhD    +4723070686    ole.oyen@ous-hf.no   
Contact: Morten Skauby, MD    +4723072265    morten.skauby@ous-hf.no   
Principal Investigator: Ole M Øyen, MD, PHD         
Sub-Investigator: Morten Skauby, MD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Ole M Øyen, MD, PhD Oslo University Hospital Rikshospitalet
Study Chair: Morten Skauby, MD Oslo University Hospital Rikshospitalet
  More Information