Trial Outcomes & Findings for Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors (NCT NCT01521871)
NCT ID: NCT01521871
Last Updated: 2014-11-04
Results Overview
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.
COMPLETED
PHASE4
64 participants
At postoperative day 2 (2 days after kidney donation)
2014-11-04
Participant Flow
Participant milestones
| Measure |
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)
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors
Baseline characteristics by cohort
| Measure |
Conventional Suture + Dressing
n=32 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)
|
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 13.58 • n=7 Participants
|
47.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Rubor Postoperative Day 2.
|
0.516 units on a scale
Standard Deviation 0.311
|
0.984 units on a scale
Standard Deviation 0.364
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Rubor Postoperative Day 4.
|
0.547 units on a scale
Standard Deviation 0.261
|
0.750 units on a scale
Standard Deviation 0.335
|
PRIMARY outcome
Timeframe: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Rubor at Discharge From Hospital.
|
0.476 units on a scale
Standard Deviation 0.288
|
0.639 units on a scale
Standard Deviation 0.279
|
PRIMARY outcome
Timeframe: Postop. day 2The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Secretion Postoperative Day 2.
|
0.328 units on a scale
Standard Deviation 0.478
|
0.594 units on a scale
Standard Deviation 0.384
|
PRIMARY outcome
Timeframe: Postop. day 4The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Secretion Postoperative Day 4.
|
0.375 units on a scale
Standard Deviation 0.484
|
0.117 units on a scale
Standard Deviation 0.275
|
PRIMARY outcome
Timeframe: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Secretion at Discharge From Hospital.
|
0.286 units on a scale
Standard Deviation 0.396
|
0.028 units on a scale
Standard Deviation 0.115
|
PRIMARY outcome
Timeframe: Postop. day 2The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Oedema Postoperative Day 2.
|
0 units on a scale
Standard Deviation 0
|
0.094 units on a scale
Standard Deviation 0.292
|
PRIMARY outcome
Timeframe: Postop. day 4The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Oedema Postoperative Day 4.
|
0 units on a scale
Standard Deviation 0
|
0.083 units on a scale
Standard Deviation 0.227
|
PRIMARY outcome
Timeframe: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Oedema at Discharge From Hospital.
|
0 units on a scale
Standard Deviation 0
|
0.111 units on a scale
Standard Deviation 0.266
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Blisters Postoperative Day 2.
|
0 units on a scale
Standard Deviation 0
|
0.156 units on a scale
Standard Deviation 0.507
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Blisters Postoperative Day 4.
|
0 units on a scale
Standard Deviation 0
|
0.200 units on a scale
Standard Deviation 0.542
|
PRIMARY outcome
Timeframe: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Blisters at Discharge From Hospital.
|
0 units on a scale
Standard Deviation 0
|
0.028 units on a scale
Standard Deviation 0.115
|
PRIMARY outcome
Timeframe: Postop. day 2The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Gaps Postoperative Day 2.
|
0.094 units on a scale
Standard Deviation 0.522
|
0 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Postop. day 4The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Gaps Postoperative Day 4.
|
0.344 units on a scale
Standard Deviation 0.888
|
0 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7The 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Wound Healing by Numerical Scales for Gaps at Discharge From Hospital.
|
0.400 units on a scale
Standard Deviation 0.917
|
0 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
TIme Consumption
|
5.832 minutes
Standard Deviation 1.785
|
8.594 minutes
Standard Deviation 2.253
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tissue Glue Wound Closure
n=32 Participants
Skin wound closure by tissue glue
Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing.
|
Conventional Suture + Dressing
n=32 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)
|
|---|---|---|
|
Patients´Self Satisfaction.
|
4.968 units on a scale
Standard Deviation 1.531
|
4.875 units on a scale
Standard Deviation 1.996
|
Adverse Events
Conventional Suture + Dressing
Tissue Glue Wound Closure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place