Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine
Oslo, 0027, Norway
Completed
NCT Number: NCT01521871
Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors
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.
Completed
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Notify MeKey information
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Skin wound closure by tissue glue
ProcedureThe glue is used both as closure device and as wound dressing.
Other names: CE-marked Liquiband Laparoscopic/Surgical: CE 0123
Skin wound closure by conventional suture + dressing
ProcedureSuture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
Primary outcomes
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Wound Healing by Numerical Scales for Rubor Postoperative Day 2.
Time frame: At postoperative day 2 (2 days after kidney donation)
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.
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Wound Healing by Numerical Scales for Rubor Postoperative Day 4.
Time frame: At postop. day 4 (4 days after kidney donation)
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.
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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
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.
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Wound Healing by Numerical Scales for Secretion Postoperative Day 2.
Time frame: Postop. day 2
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.
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Wound Healing by Numerical Scales for Secretion Postoperative Day 4.
Time frame: Postop. day 4
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
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.
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Wound Healing by Numerical Scales for Oedema Postoperative Day 2.
Time frame: Postop. day 2
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.
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Wound Healing by Numerical Scales for Oedema Postoperative Day 4.
Time frame: Postop. day 4
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.
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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
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.
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Wound Healing by Numerical Scales for Blisters Postoperative Day 2.
Time frame: At postop. day 2 (2 days after kidney donation)
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.
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Wound Healing by Numerical Scales for Blisters Postoperative Day 4.
Time frame: At postop. day 4 (4 days after kidney donation)
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
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
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
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
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.
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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.
The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.
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Patients´Self Satisfaction.
Time frame: These data were collected at the day of discharge from hospital (postoperative day 4-8).
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.
Sponsors and collaborators
Lead sponsor
Oslo University Hospital
Other
Registry information
Official study title
A Prospective, Randomised Study on Tissue Glue (Cyanoacrylate) Versus Conventional Suture for Skin Closure in Laparoscopic Living Donor Nephrectomy
Acronym: TG-CYANO
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2013
- First posted
- Jan 31, 2012
- Registry last updated
- Nov 4, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.