Trial Outcomes & Findings for Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty (NCT NCT02460172)
NCT ID: NCT02460172
Last Updated: 2019-03-05
Results Overview
Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
6-8 weeks post surgery
Results posted on
2019-03-05
Participant Flow
This is a split person study where one knee is assigned Zip, the other knee is assigned Staples. 50 knees were closed on 25 participants.
Unit of analysis: knees
Participant milestones
| Measure |
All Participants
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|
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Overall Study
STARTED
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25 50
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Overall Study
COMPLETED
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25 50
|
|
Overall Study
NOT COMPLETED
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0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|
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Age, Continuous
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62.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
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Sex: Female, Male
Female
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12 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
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23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African Amer.
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2 Participants
n=5 Participants
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|
Region of Enrollment
United States
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25 Participants
n=5 Participants
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|
Range of Motion
Knees assigned Zip closure
|
121 degrees
STANDARD_DEVIATION 13.66 • n=5 Participants
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|
Range of Motion
Knees assigned Staple closure
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118 degrees
STANDARD_DEVIATION 25.99 • n=5 Participants
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PRIMARY outcome
Timeframe: 6-8 weeks post surgeryPatient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating.
Outcome measures
| Measure |
Zip Surgical Skin Closure
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
|
Steel Staples
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|---|
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Incision Appearance / Scar Cosmesis
Patient Rating
|
1.3 units on a scale
Standard Deviation 0.5
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2.6 units on a scale
Standard Deviation 2.4
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|
Incision Appearance / Scar Cosmesis
Surgeon Rating
|
1.9 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 1.0
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|
Incision Appearance / Scar Cosmesis
Plastic Surgeon Rating
|
3.7 units on a scale
Standard Deviation 2.0
|
4.8 units on a scale
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: 6-8 weeks post opClosure method satisfaction will be collected by a 5 point satisfaction scale: 1. Very Satisfied 2. Satisfied 3. Neither 4. Dissatisfied 5. Very Dissatisfied A lower score means more satisfaction with the closure method.
Outcome measures
| Measure |
Zip Surgical Skin Closure
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
|
Steel Staples
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|---|
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Surgeon Closure Method Satisfaction
Surgeon Very Satisfied
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17 Participants
|
5 Participants
|
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Surgeon Closure Method Satisfaction
Surgeon Satisfied
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7 Participants
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17 Participants
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Surgeon Closure Method Satisfaction
Surgeon Neither Satisfied or Dissatisfied
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1 Participants
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3 Participants
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SECONDARY outcome
Timeframe: Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)Population: Patient incisional pain scores for Zip side and incisional pain scores for Staples side were collected (0=no pain, 10=worst pain imaginable)
Pain levels will be collected using a 10 point VAS scale.
Outcome measures
| Measure |
Zip Surgical Skin Closure
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
|
Steel Staples
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|---|
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Patient Pain - Incisional and General
Discharge Pain
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1.8 units on a scale
Standard Deviation 2.0
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2.4 units on a scale
Standard Deviation 2.6
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|
Patient Pain - Incisional and General
2 Week Pain pre removal
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1.4 units on a scale
Standard Deviation 1.7
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2.0 units on a scale
Standard Deviation 1.8
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|
Patient Pain - Incisional and General
2 Week Pain post removal
|
0.7 units on a scale
Standard Deviation 1.1
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1.6 units on a scale
Standard Deviation 1.2
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|
Patient Pain - Incisional and General
6 to 8 Week Pain
|
0.5 units on a scale
Standard Deviation 0.1
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0.9 units on a scale
Standard Deviation 1.4
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SECONDARY outcome
Timeframe: 6 to 8 wk follow up visitScar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied
Outcome measures
| Measure |
Zip Surgical Skin Closure
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
|
Steel Staples
n=25 Participants
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|---|
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Surgeon and Patient Scar Satisfaction
Surgeon Scar Satisfaction · Very Satisfied
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17 Participants
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5 Participants
|
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Surgeon and Patient Scar Satisfaction
Surgeon Scar Satisfaction · Satisfied
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7 Participants
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17 Participants
|
|
Surgeon and Patient Scar Satisfaction
Surgeon Scar Satisfaction · Neither
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1 Participants
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3 Participants
|
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Surgeon and Patient Scar Satisfaction
Surgeon Scar Satisfaction · Dissatisfied
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0 Participants
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0 Participants
|
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Surgeon and Patient Scar Satisfaction
Surgeon Scar Satisfaction · Very Dissatisfied
|
0 Participants
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0 Participants
|
|
Surgeon and Patient Scar Satisfaction
Patient Scar Satisfaction · Very Satisfied
|
18 Participants
|
8 Participants
|
|
Surgeon and Patient Scar Satisfaction
Patient Scar Satisfaction · Satisfied
|
4 Participants
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7 Participants
|
|
Surgeon and Patient Scar Satisfaction
Patient Scar Satisfaction · Neither
|
3 Participants
|
7 Participants
|
|
Surgeon and Patient Scar Satisfaction
Patient Scar Satisfaction · Dissatisfied
|
0 Participants
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3 Participants
|
|
Surgeon and Patient Scar Satisfaction
Patient Scar Satisfaction · Very Dissatisfied
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0 Participants
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0 Participants
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SECONDARY outcome
Timeframe: 2 weeks and 6-8 weeksKnee Range of Motion for each knee will be measured in degrees
Outcome measures
| Measure |
Zip Surgical Skin Closure
n=25 knees
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
|
Steel Staples
n=25 knees
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|---|
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Range of Motion
6-8 Week Range of Motion
|
122 degrees
Standard Deviation 10.78
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122 degrees
Standard Deviation 10.82
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|
Range of Motion
2 week Range of Motion
|
109 degrees
Standard Deviation 11.79
|
105 degrees
Standard Deviation 13.64
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Adverse Events
Zip Surgical Skin Closure
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Steel Staples
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zip Surgical Skin Closure
n=25 participants at risk
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
|
Steel Staples
n=25 participants at risk
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
Zip Surgical Skin Closure: Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel Staples: Skin closure device for the closure of the skin layer following surgical incision.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Superficial Skin Peeling
|
4.0%
1/25 • Number of events 1 • Up to Study Exit at 6 to 8 Week Follow Up
No Serious Adverse Events No All Cause Mortality
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0.00%
0/25 • Up to Study Exit at 6 to 8 Week Follow Up
No Serious Adverse Events No All Cause Mortality
|
Additional Information
Wendy Winters, Clinical Project Manager
ZipLine Medical
Phone: 408-506-1866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place