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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue glue wound closure | Experimental | Skin wound closure by tissue glue |
|
| Conventional suture + dressing | Active Comparator | Skin wound closure by conventional suture + dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin wound closure by tissue glue | Procedure | The glue is used both as closure device and as wound dressing. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole M Øyen, MD, PhD | Oslo University Hospital | Principal Investigator |
| Morten Skauby, MD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Rikshospitalet, Clinic for Cancer, Surgery and Transplantation, Dep. for Transplantation Medicine | Oslo | Oslo | 0027 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15450839 | Background | 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. doi: 10.1016/j.amjsurg.2004.04.006. | |
| 16804456 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Suture + Dressing | Skin wound closure by conventional suture + dressing Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor) |
| FG001 | Tissue Glue Wound Closure | Skin wound closure by tissue glue Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Suture + Dressing | Skin wound closure by conventional suture + dressing Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor) |
| BG001 | Tissue Glue Wound Closure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At postoperative day 2 (2 days after kidney donation) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Suture + Dressing | Skin wound closure by conventional suture + dressing Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ole Øyen | Oslo University Hospital, Rikshospitalet | +4723070000 | ooyen@ous-hf.no |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Skin wound closure by conventional suture + dressing | Procedure | Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor) |
|
| 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:
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). |
| 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. doi: 10.1097/00129689-200606000-00005. |
| 12137689 | Background | 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;2002(3):CD003326. doi: 10.1002/14651858.CD003326. |
| 20464728 | Background | 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. |
| Background | Liversedge NH. Get Stuck In! Hands On Experiences With Surgical Skin Glue. Obs & Gynae Product News 2007; Issue 14: 24-28 |
Skin wound closure by tissue glue Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Skin wound closure by conventional suture + dressing
Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At postop. day 4 (4 days after kidney donation) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Postop. day 2 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Postop. day 4 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 |
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Postop. day 2 |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Postop. day 4 |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 |
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | At postop. day 2 (2 days after kidney donation) |
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | At postop. day 4 (4 days after kidney donation) |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Postop. day 2 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Postop. day 4 |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7 |
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| 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. | Posted | Mean | Standard Deviation | minutes | The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing. |
|
|
|
| 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:
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. | Posted | Mean | Standard Deviation | units on a scale | These data were collected at the day of discharge from hospital (postoperative day 4-8). |
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| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Tissue Glue Wound Closure | Skin wound closure by tissue glue Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing. | 0 | 32 | 0 | 32 |
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