Skin Closure of Surgical Incisions by Tissue Glue vs Suture
Conditions
Keywords
Tissue glue, Cyanoacrylate, Wound closure, Living donor nephrectomy, Surgical wound closure
Brief summary
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
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.
Interventions
PROCEDURESkin wound closure by tissue glue
The glue is used both as closure device and as wound dressing.
PROCEDURESkin wound closure by conventional suture + dressing
Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing by Numerical Scales for Rubor Postoperative Day 2. | 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. |
| Wound Healing by Numerical Scales for Rubor Postoperative Day 4. | 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. |
| Wound Healing by Numerical Scales for Rubor at Discharge From Hospital. | 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. |
| Wound Healing by Numerical Scales for Secretion Postoperative Day 2. | 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. |
| Wound Healing by Numerical Scales for Secretion Postoperative Day 4. | 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. | 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. |
| Wound Healing by Numerical Scales for Oedema Postoperative Day 2. | 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. |
| Wound Healing by Numerical Scales for Oedema Postoperative Day 4. | 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. |
| Wound Healing by Numerical Scales for Oedema at Discharge From Hospital. | 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. |
| Wound Healing by Numerical Scales for Blisters Postoperative Day 2. | 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. |
| Wound Healing by Numerical Scales for Blisters Postoperative Day 4. | 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. | 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. | 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. | 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. | 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. |
| 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. | 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. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 32 |
| 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. | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Tissue Glue Wound Closure | Conventional Suture + Dressing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 0 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 32 Participants | 58 Participants |
| Age, Continuous | 48.4 years STANDARD_DEVIATION 13.58 | 47.4 years STANDARD_DEVIATION 11.25 | 47.9 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment Norway | 32 participants | 32 participants | 64 participants |
| Sex: Female, Male Female | 22 Participants | 16 Participants | 38 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
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.
Time frame: These data were collected at the day of discharge from hospital (postoperative day 4-8).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Patients´Self Satisfaction. | 4.968 units on a scale | Standard Deviation 1.531 |
| Conventional Suture + Dressing | Patients´Self Satisfaction. | 4.875 units on a scale | Standard Deviation 1.996 |
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | TIme Consumption | 5.832 minutes | Standard Deviation 1.785 |
| Conventional Suture + Dressing | TIme Consumption | 8.594 minutes | Standard Deviation 2.253 |
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.
Time frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Blisters at Discharge From Hospital. | 0 units on a scale | Standard Deviation 0 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Blisters at Discharge From Hospital. | 0.028 units on a scale | Standard Deviation 0.115 |
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.
Time frame: At postop. day 2 (2 days after kidney donation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Blisters Postoperative Day 2. | 0 units on a scale | Standard Deviation 0 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Blisters Postoperative Day 2. | 0.156 units on a scale | Standard Deviation 0.507 |
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.
Time frame: At postop. day 4 (4 days after kidney donation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Blisters Postoperative Day 4. | 0 units on a scale | Standard Deviation 0 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Blisters Postoperative Day 4. | 0.200 units on a scale | Standard Deviation 0.542 |
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.
Time frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Gaps at Discharge From Hospital. | 0.400 units on a scale | Standard Deviation 0.917 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Gaps at Discharge From Hospital. | 0 units on a scale | Standard Deviation 0 |
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.
Time frame: Postop. day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Gaps Postoperative Day 2. | 0.094 units on a scale | Standard Deviation 0.522 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Gaps Postoperative Day 2. | 0 units on a scale | Standard Deviation 0 |
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.
Time frame: Postop. day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Gaps Postoperative Day 4. | 0.344 units on a scale | Standard Deviation 0.888 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Gaps Postoperative Day 4. | 0 units on a scale | Standard Deviation 0 |
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.
Time frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Oedema at Discharge From Hospital. | 0 units on a scale | Standard Deviation 0 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Oedema at Discharge From Hospital. | 0.111 units on a scale | Standard Deviation 0.266 |
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.
Time frame: Postop. day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Oedema Postoperative Day 2. | 0 units on a scale | Standard Deviation 0 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Oedema Postoperative Day 2. | 0.094 units on a scale | Standard Deviation 0.292 |
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.
Time frame: Postop. day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Oedema Postoperative Day 4. | 0 units on a scale | Standard Deviation 0 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Oedema Postoperative Day 4. | 0.083 units on a scale | Standard Deviation 0.227 |
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.
Time frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Rubor at Discharge From Hospital. | 0.476 units on a scale | Standard Deviation 0.288 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Rubor at Discharge From Hospital. | 0.639 units on a scale | Standard Deviation 0.279 |
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.
Time frame: At postoperative day 2 (2 days after kidney donation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Rubor Postoperative Day 2. | 0.516 units on a scale | Standard Deviation 0.311 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Rubor Postoperative Day 2. | 0.984 units on a scale | Standard Deviation 0.364 |
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.
Time frame: At postop. day 4 (4 days after kidney donation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Rubor Postoperative Day 4. | 0.547 units on a scale | Standard Deviation 0.261 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Rubor Postoperative Day 4. | 0.750 units on a scale | Standard Deviation 0.335 |
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.
Time frame: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Secretion at Discharge From Hospital. | 0.286 units on a scale | Standard Deviation 0.396 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Secretion at Discharge From Hospital. | 0.028 units on a scale | Standard Deviation 0.115 |
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.
Time frame: Postop. day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Secretion Postoperative Day 2. | 0.328 units on a scale | Standard Deviation 0.478 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Secretion Postoperative Day 2. | 0.594 units on a scale | Standard Deviation 0.384 |
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.
Time frame: Postop. day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tissue Glue Wound Closure | Wound Healing by Numerical Scales for Secretion Postoperative Day 4. | 0.375 units on a scale | Standard Deviation 0.484 |
| Conventional Suture + Dressing | Wound Healing by Numerical Scales for Secretion Postoperative Day 4. | 0.117 units on a scale | Standard Deviation 0.275 |