Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Skin Closure of Surgical Incisions by Tissue Glue vs Suture

Intervention / Treatment
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* Procedure: Skin wound closure by tissue glue
* Procedure: Skin wound closure by conventional suture + dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue glue wound closure<br>Skin wound closure by tissue glue | Procedure: Skin wound closure by tissue glue<br>* The glue is used both as closure device and as wound dressing.<br>* Other names: CE-marked Liquiband Laparoscopic/Surgical: CE 0123;|
| Active Comparator: Conventional suture + dressing<br>Skin wound closure by conventional suture + dressing | Procedure: Skin wound closure by conventional suture + dressing<br>* Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing by Numerical Scales for Rubor Postoperative Day 2. | 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. | At postoperative day 2 (2 days after kidney donation) | 
| Wound Healing by Numerical Scales for Rubor Postoperative Day 4. | 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. | At postop. day 4 (4 days after kidney donation) | 
| Wound Healing by Numerical Scales for Rubor at Discharge From Hospital. | 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. | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 | 
| Wound Healing by Numerical Scales for Secretion Postoperative 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. | Postop. day 2 | 
| Wound Healing by Numerical Scales for Secretion Postoperative 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. | Postop. day 4 | 
| Wound Healing by Numerical Scales for Secretion at Discharge From Hospital. | 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. | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 | 
| Wound Healing by Numerical Scales for Oedema Postoperative 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. | Postop. day 2 | 
| Wound Healing by Numerical Scales for Oedema Postoperative 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. | Postop. day 4 | 
| Wound Healing by Numerical Scales for Oedema at Discharge From Hospital. | 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. | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 | 
| Wound Healing by Numerical Scales for Blisters Postoperative Day 2. | 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. | At postop. day 2 (2 days after kidney donation) | 
| Wound Healing by Numerical Scales for Blisters Postoperative Day 4. | 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. | At postop. day 4 (4 days after kidney donation) | 
| Wound Healing by Numerical Scales for Blisters at Discharge From Hospital. | 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. | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 | 
| Wound Healing by Numerical Scales for Gaps Postoperative 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. | Postop. day 2 | 
| Wound Healing by Numerical Scales for Gaps Postoperative 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. | Postop. day 4 | 
| Wound Healing by Numerical Scales for Gaps at Discharge From Hospital. | 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. | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 | 
| TIme Consumption | 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. | 
| Patients´Self Satisfaction. | 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. | These data were collected at the day of discharge from hospital (postoperative day 4-8). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tissue glue, Cyanoacrylate, Wound closure, Living donor nephrectomy, Surgical wound closure