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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ole Morten Øyen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01521871
First received: January 12, 2012
Last updated: November 3, 2014
Last verified: November 2014
  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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Wound Healing by Numerical Scales for Rubor Postoperative Day 2. [ Time Frame: At postoperative day 2 (2 days after kidney donation) ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Rubor Postoperative Day 4. [ Time Frame: At postop. day 4 (4 days after kidney donation) ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Rubor at Discharge From 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 ]
    The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Secretion Postoperative Day 2. [ Time Frame: Postop. day 2 ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Secretion Postoperative Day 4. [ Time Frame: Postop. day 4 ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Secretion at Discharge From 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 ]
    The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Oedema Postoperative Day 2. [ Time Frame: Postop. day 2 ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Oedema Postoperative Day 4. [ Time Frame: Postop. day 4 ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Oedema at Discharge From 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 ]
    The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Blisters Postoperative Day 2. [ Time Frame: At postop. day 2 (2 days after kidney donation) ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Blisters Postoperative Day 4. [ Time Frame: At postop. day 4 (4 days after kidney donation) ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Blisters at Discharge From 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 ]
    The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Gaps Postoperative Day 2. [ Time Frame: Postop. day 2 ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Gaps Postoperative Day 4. [ Time Frame: Postop. day 4 ] [ Designated as safety issue: No ]
    The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • Wound Healing by Numerical Scales for Gaps at Discharge From 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 ]
    The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.

  • TIme Consumption [ Time Frame: The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing. ] [ Designated as safety issue: No ]
    The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.

  • Patients´Self Satisfaction. [ Time Frame: These data were collected at the day of discharge from hospital (postoperative day 4-8). ] [ Designated as safety issue: No ]

    The patients` self-satisfaction was evaluated by means of a questionnaire rating the following 3 domains on a numerical (1-5) scale:

    • Total satisfaction regarding wound healing/wound care. 1 (satisfied) to 5 (dissatisfied)
    • Satisfaction regarding wound discomfort; pain, itching, paresthesia, pressure etc. 1 (almost no discomfort) to 5 (lot of discomfort)
    • Satisfaction regarding wound care; suppleness, practicability versus mobilization, showering etc. 1 (almost no practical challenges) to 5 (lot of practical challenges)

    Patients' Self Satisfaction score was the sum of three domains, ranges from 3 (completely satisfied) to 15 (completely dissatisfied).

    These data were collected at the day of discharge, with guidance from two interviewers.



Enrollment: 64
Study Start Date: January 2012
Study Completion Date: February 2013
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 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.

  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

Locations
Norway
Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine
Oslo, Norway, 0027
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

Additional Information:
Publications:
Responsible Party: Ole Morten Øyen, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01521871     History of Changes
Other Study ID Numbers: 214603
Study First Received: January 12, 2012
Results First Received: December 13, 2013
Last Updated: November 3, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Tissue glue
Cyanoacrylate
Wound closure
Living donor nephrectomy
Surgical wound closure

ClinicalTrials.gov processed this record on November 20, 2014