Skin Closure of Surgical Incisions by Tissue Glue vs Suture Clinical Trial
— TG-CYANOOfficial title:
A Prospective, Randomised Study on Tissue Glue (Cyanoacrylate) Versus Conventional Suture for Skin Closure in Laparoscopic Living Donor Nephrectomy
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | February 2013 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Norway | Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital |
Norway,
Blondeel PN, Murphy JW, Debrosse D, Nix JC 3rd, Puls LE, Theodore N, Coulthard P. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods. Am J Surg. 2004 Sep;188(3):307-13. — View Citation
Coulthard P, Esposito M, Worthington HV, van der Elst M, van Waes OJ, Darcey J. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2010 May 12;(5):CD004287. doi: 10.1002/14651858.CD004287.pub3. Review. Update in: Cochrane Database Syst Rev. 2014;11:CD004287. — View Citation
Dowson CC, Gilliam AD, Speake WJ, Lobo DN, Beckingham IJ. A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures. Surg Laparosc Endosc Percutan Tech. 2006 Jun;16(3):146-50. — View Citation
Farion K, Osmond MH, Hartling L, Russell K, Klassen T, Crumley E, Wiebe N. Tissue adhesives for traumatic lacerations in children and adults. Cochrane Database Syst Rev. 2002;(3):CD003326. Review. — View Citation
Liversedge NH. Get Stuck In! Hands On Experiences With Surgical Skin Glue. Obs & Gynae Product News 2007; Issue 14: 24-28
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Primary | 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) | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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) | No |
| Primary | 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) | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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. | No |
| Primary | 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). | No |