Trial Outcomes & Findings for Orthopaedic Surgical Wound Closure Comparison Study (NCT NCT05251064)
NCT ID: NCT05251064
Last Updated: 2025-06-15
Results Overview
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
2-Weeks post-operative
Results posted on
2025-06-15
Participant Flow
Participant milestones
| Measure |
Suture
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
18
|
|
Overall Study
COMPLETED
|
10
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
31 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=32 Participants
|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 18.5 • n=10 Participants
|
40.9 years
STANDARD_DEVIATION 10.6 • n=11 Participants
|
34.6 years
STANDARD_DEVIATION 16.7 • n=11 Participants
|
38.5 years
STANDARD_DEVIATION 15.3 • n=32 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
6 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
19 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
5 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
13 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
32 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: 2-Weeks post-operativeScores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Outcome measures
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Stony Brook Scar Evaluation Scale
|
2.8 score on a scale
Standard Deviation 0.92
|
4.09 score on a scale
Standard Deviation 0.70
|
3.45 score on a scale
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: 3-Months post operativePopulation: All subjects who completed 3-Month follow-up and were randomized to their respective wound closure device.
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Outcome measures
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Stony Brook Scar Evaluation Scale
|
2.85 score on a scale
Standard Deviation 1.20
|
3.82 score on a scale
Standard Deviation 0.60
|
3.0 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: During the procedure, from beginning of wound closure to the completion of wound closureThe amount of time in seconds that it took to perform closure of the incision.
Outcome measures
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Time to Close
|
266.31 seconds
Standard Deviation 193.59
|
91.09 seconds
Standard Deviation 39.53
|
123.27 seconds
Standard Deviation 124.23
|
SECONDARY outcome
Timeframe: During the procedure, obtained after incision was closed.This is the measure in centimeters of the incision.
Outcome measures
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Length of Incision
|
9.78 centimeters
Standard Deviation 4.87
|
8.23 centimeters
Standard Deviation 4.09
|
8.1 centimeters
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: 2 weeks post operativeScores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.
Outcome measures
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Patient Satisfaction
|
8.33 units on a scale
Standard Deviation 1.66
|
8.82 units on a scale
Standard Deviation 1.33
|
8.64 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 3 months post operativeScores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.
Outcome measures
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Patient Satisfaction
|
8.11 units on a scale
Standard Deviation 1.95
|
8.727 units on a scale
Standard Deviation 1.73
|
8.82 units on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Once (at application)Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower satisfaction.
Outcome measures
| Measure |
Suture
n=10 Participants
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=11 Participants
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=11 Participants
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Surgeon Satisfaction
|
7.11 units on a scale
Standard Deviation 3.62
|
8.18 units on a scale
Standard Deviation 2.09
|
8.0 units on a scale
Standard Deviation 1.55
|
Adverse Events
Suture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adhesive Wound Closure Device
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Adhesive Wound Closure Device With Zip Ties
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suture
n=19 participants at risk
Standard suture wound closure
Suture: Standard suture wound closure device.
|
Adhesive Wound Closure Device
n=19 participants at risk
Clozex wound closure device
Clozex: Interlaced adhesive wound closure device.
|
Adhesive Wound Closure Device With Zip Ties
n=18 participants at risk
Zipline wound closure device
Zipline: Adhesive wound closure device using zip-tie like strips.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.00%
0/19 • 3 months.
|
5.3%
1/19 • Number of events 1 • 3 months.
|
0.00%
0/18 • 3 months.
|
|
Skin and subcutaneous tissue disorders
blisters
|
0.00%
0/19 • 3 months.
|
5.3%
1/19 • Number of events 1 • 3 months.
|
11.1%
2/18 • Number of events 2 • 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place