Trial Outcomes & Findings for A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study (NCT NCT06232018)
NCT ID: NCT06232018
Last Updated: 2026-01-21
Results Overview
Evaluated Patient observer scar assessment score (POSAS) * The POSAS is composed of two numerical scales that evaluate signs and symptoms of healing. * Consists of the two following parts: a scale for patients and a scale for observers. * Both contain six items punctuated numerically from 1 to 10 * The lowest score is 1 and corresponds to the normal skin * The highest score is 10 and corresponds to the worst skin * The total score of both scales can be calculated simply by adding the scores of each of the six items. * The total score will range from 6 to 60.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
6 weeks
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
Skin Adhesive
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Skin Adhesive
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
|---|---|---|
|
Overall Study
withdrew due to trauma
|
0
|
2
|
Baseline Characteristics
A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study
Baseline characteristics by cohort
| Measure |
Skin Adhesive
n=40 Participants
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
n=40 Participants
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.78 years
STANDARD_DEVIATION 8.12 • n=37 Participants
|
67.43 years
STANDARD_DEVIATION 5.97 • n=44 Participants
|
67.61 years
STANDARD_DEVIATION 6.08 • n=40 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=37 Participants
|
5 Participants
n=44 Participants
|
41 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=37 Participants
|
35 Participants
n=44 Participants
|
39 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=37 Participants
|
40 Participants
n=44 Participants
|
80 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
BMI
|
26.89 Kg/m2
STANDARD_DEVIATION 3.77 • n=37 Participants
|
28.23 Kg/m2
STANDARD_DEVIATION 4.20 • n=44 Participants
|
27.56 Kg/m2
STANDARD_DEVIATION 4.02 • n=40 Participants
|
|
Hypertension
|
32 participants
n=37 Participants
|
34 participants
n=44 Participants
|
66 participants
n=40 Participants
|
|
Diabetic mellitus
|
6 participants
n=37 Participants
|
10 participants
n=44 Participants
|
16 participants
n=40 Participants
|
|
Dyslipidemia
|
27 participants
n=37 Participants
|
28 participants
n=44 Participants
|
55 participants
n=40 Participants
|
|
Smoking
|
0 participants
n=37 Participants
|
1 participants
n=44 Participants
|
1 participants
n=40 Participants
|
|
Alcohol
|
0 participants
n=37 Participants
|
2 participants
n=44 Participants
|
2 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 6 weeksEvaluated Patient observer scar assessment score (POSAS) * The POSAS is composed of two numerical scales that evaluate signs and symptoms of healing. * Consists of the two following parts: a scale for patients and a scale for observers. * Both contain six items punctuated numerically from 1 to 10 * The lowest score is 1 and corresponds to the normal skin * The highest score is 10 and corresponds to the worst skin * The total score of both scales can be calculated simply by adding the scores of each of the six items. * The total score will range from 6 to 60.
Outcome measures
| Measure |
Skin Adhesive
n=40 Participants
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
n=38 Participants
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
|---|---|---|
|
Patient Observer Scar Assessment Score (POSAS)
|
20 score on a scale
Inter-Quartile Range 6.56 • Interval 14.0 to 26.0
|
21 score on a scale
Inter-Quartile Range 4.88 • Interval 14.0 to 26.0
|
SECONDARY outcome
Timeframe: 3 monthsEvaluated Patient observer scar assessment score (POSAS) * The POSAS is composed of two numerical scales that evaluate signs and symptoms of healing. * Consists of the two following parts: a scale for patients and a scale for observers. * Both contain six items punctuated numerically from 1 to 10 * The lowest score is 1 and corresponds to the normal skin * The highest score is 10 and corresponds to the worst skin * The total score of both scales can be calculated simply by adding the scores of each of the six items. * The total score will range from 6 to 60.
Outcome measures
| Measure |
Skin Adhesive
n=40 Participants
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
n=38 Participants
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
|---|---|---|
|
Patient Observer Scar Assessment Score (POSAS)
|
13 score on a scale
Interval 10.0 to 19.0
|
15 score on a scale
Interval 10.0 to 20.0
|
SECONDARY outcome
Timeframe: 6 weeksEvaluated vancouver scar scale Vancouver Scar Scale (VSS) is used for validated scar assessment tools. Consist of the four following parts: vascularity(0-3) , height(0-3), pliability(0-5), and pigmentation(0-2). Each characteristic is given a score, which are added together to give an overall score between 0 and 13. The lowest score is 0 and corresponds to the normal skin. The highest score is 13 and corresponds to the worst skin.
Outcome measures
| Measure |
Skin Adhesive
n=40 Participants
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
n=38 Participants
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
|---|---|---|
|
Vancouver Scar Scale
|
5 Score (0-13)
Interval 5.0 to 6.0
|
5 Score (0-13)
Interval 5.0 to 6.0
|
SECONDARY outcome
Timeframe: 2 weeksWound leakage was evaluated by measuring the total blood-stained area on the waterproof dressing. The dressing was placed on a standardized 1 mm² grid, and the stained area was calculated in square millimeters (mm²).
Outcome measures
| Measure |
Skin Adhesive
n=40 Participants
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
n=38 Participants
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
|---|---|---|
|
Wound Leakage
|
23 square millimeter (mm²)
Interval 9.8 to 57.5
|
79 square millimeter (mm²)
Interval 42.8 to 108.8
|
SECONDARY outcome
Timeframe: 3 monthsEvaluated vancouver scar scale Vancouver Scar Scale (VSS) is used for validated scar assessment tools. Consist of the four following parts: vascularity(0-3) , height(0-3), pliability(0-5), and pigmentation(0-2). Each characteristic is given a score, which are added together to give an overall score between 0 and 13. The lowest score is 0 and corresponds to the normal skin. The highest score is 13 and corresponds to the worst skin.
Outcome measures
| Measure |
Skin Adhesive
n=40 Participants
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
Skin adhesive (Dermabond): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
Skin Adhesive Plus Polyester Mesh
n=38 Participants
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
skin adhesive + polyester mesh (Dermabond prineo): - Arthrotomy (deep layer) is repaired using number 1-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* Subcuticular suture is repaired using number 3-0 monofilament absorbable suture (STRATAFIX™ , Ethicon, johnson \& johnson, Somerville, NJ)
* After subticular sutures was done
* 2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ) was applied
|
|---|---|---|
|
Vancouver Scar Scale
|
5 Score (0-13)
Interval 5.0 to 6.0
|
5 Score (0-13)
Interval 5.0 to 6.0
|
Adverse Events
Skin Adhesive
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Skin Adhesive Plus Polyester Mesh
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Skin Adhesive
n=40 participants at risk
2-octylcyanoacrylate glue (DERMABOND ADVANCED®, Ethicon, johnson \& johnson, Somerville, NJ)
|
Skin Adhesive Plus Polyester Mesh
n=38 participants at risk
2-octylcyanoacrylate glue + polyester mesh ( DERMABOND PRINEO®, Ethicon, johnson \& johnson, Somerville, NJ)
|
|---|---|---|
|
Surgical and medical procedures
Allergic contact dermatitis
|
2.5%
1/40 • Number of events 1 • From 2 weeks to 12 weeks
|
10.5%
4/38 • Number of events 4 • From 2 weeks to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place