Trial Outcomes & Findings for A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications (NCT NCT03134209)
NCT ID: NCT03134209
Last Updated: 2021-09-14
Results Overview
The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
4 Days
Results posted on
2021-09-14
Participant Flow
Participant milestones
| Measure |
Zipper Surgical Skin Closure
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin.
|
Monocryl + Dermabond
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Monocryl + Dermabond: conventional sutures and skin adhesive glue
|
Polyester Mesh + Dermabond
The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study
Polyester mesh + Dermabond: conventional sutures and skin adhesive glue
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
54
|
53
|
|
Overall Study
COMPLETED
|
53
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Baseline characteristics by cohort
| Measure |
Zipper Surgical Skin Closure
n=53 Participants
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin.
|
Monocryl + Dermabond
n=54 Participants
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Monocryl + Dermabond: conventional sutures and skin adhesive glue
|
Polyester Mesh + Dermabond
n=53 Participants
The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study
Polyester mesh + Dermabond: conventional sutures and skin adhesive glue
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
64.56 years
STANDARD_DEVIATION 10.37 • n=7 Participants
|
66.51 years
STANDARD_DEVIATION 8.92 • n=5 Participants
|
65.78 years
STANDARD_DEVIATION 9.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
53 participants
n=5 Participants
|
160 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 DaysThe visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable).
Outcome measures
| Measure |
Zipper Surgical Skin Closure
n=53 Participants
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin.
|
Monocryl + Dermabond
n=54 Participants
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Monocryl + Dermabond: conventional sutures and skin adhesive glue
|
Polyester Mesh + Dermabond
n=53 Participants
The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study
Polyester mesh + Dermabond: conventional sutures and skin adhesive glue
|
|---|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
4.53 score on a scale
Standard Deviation 1.85
|
4.48 score on a scale
Standard Deviation 1.78
|
4.54 score on a scale
Standard Deviation 1.76
|
Adverse Events
Zipper Surgical Skin Closure
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Monocryl + Dermabond
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Polyester Mesh + Dermabond
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zipper Surgical Skin Closure
n=53 participants at risk
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin.
|
Monocryl + Dermabond
n=54 participants at risk
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Monocryl + Dermabond: conventional sutures and skin adhesive glue
|
Polyester Mesh + Dermabond
n=53 participants at risk
The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study
Polyester mesh + Dermabond: conventional sutures and skin adhesive glue
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Revision Surgery
|
0.00%
0/53 • 30 days following the last administration of study treatment
|
1.9%
1/54 • 30 days following the last administration of study treatment
|
1.9%
1/53 • 30 days following the last administration of study treatment
|
Other adverse events
| Measure |
Zipper Surgical Skin Closure
n=53 participants at risk
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
Zipper surgical skin closure: The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin.
|
Monocryl + Dermabond
n=54 participants at risk
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Monocryl + Dermabond: conventional sutures and skin adhesive glue
|
Polyester Mesh + Dermabond
n=53 participants at risk
The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study
Polyester mesh + Dermabond: conventional sutures and skin adhesive glue
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Wound Drainage
|
3.8%
2/53 • 30 days following the last administration of study treatment
|
1.9%
1/54 • 30 days following the last administration of study treatment
|
1.9%
1/53 • 30 days following the last administration of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place