Trial Outcomes & Findings for Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture (NCT NCT00959374)
NCT ID: NCT00959374
Last Updated: 2013-04-17
Results Overview
In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
229 participants
Primary outcome timeframe
At time of surgery
Results posted on
2013-04-17
Participant Flow
First subject was consented 12Aug2009 and last subject final follow up visit 15May2011. 241 subjects were enrolled from 9 sites in the USA and Europe. Of those, 229 were consented, randomized and treated. All subjects were volunteers scheduled for individual or combined abdominoplasty, mastopexy or reduction mammaplasty.
Participant milestones
| Measure |
V-loc and Monocryl
Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
|
|---|---|
|
Overall Study
STARTED
|
241
|
|
Overall Study
COMPLETED
|
218
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
V-loc and Monocryl
Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
14
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Implant Removed/Not Replaced
|
4
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
Baseline characteristics by cohort
| Measure |
V-loc and Monocryl
n=229 Participants
All randomized subjects
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
229 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age Continuous
|
42.6 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Region of Enrollment
Europe
|
86 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
143 participants
n=99 Participants
|
|
Surgical Procedure
|
229 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At time of surgeryPopulation: Includes only those subjects where a deep dermal layer was closed.
In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.
Outcome measures
| Measure |
V-Loc 180 / 90 Wound Closure Device
n=229 Participants
Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
|
3-0 Monocryl Sutures
n=229 Participants
Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
|
|---|---|---|
|
Total Dermal Closure Time
|
12 Minutes
Standard Deviation 4.6
|
19.2 Minutes
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Subjects who did not return for the 12 week follow-up visit were excluded from the analysis.
Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).
Outcome measures
| Measure |
V-Loc 180 / 90 Wound Closure Device
n=190 Participants
Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
|
3-0 Monocryl Sutures
n=190 Participants
Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
|
|---|---|---|
|
Cosmesis
|
13.7 units on a scale
Standard Deviation 2.8
|
13.6 units on a scale
Standard Deviation 3.1
|
Adverse Events
V-Loc 180 / 90
Serious events: 4 serious events
Other events: 72 other events
Deaths: 0 deaths
Control - Monocryl 3-0
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Midline
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Non-protocol Incision or Systemic Events
Serious events: 11 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V-Loc 180 / 90
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
|
Control - Monocryl 3-0
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
|
Midline
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm.
|
Non-protocol Incision or Systemic Events
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Bleeding Artery
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
0.00%
0/229
|
|
Surgical and medical procedures
Wound Infection
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Surgical and medical procedures
Wound Dehiscence (Adjudicated to Yes)
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Surgical and medical procedures
Abcess
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Surgical and medical procedures
Seroma
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Respiratory/Cardiac Arrest
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Surgical and medical procedures
Allergic Reaction
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
General disorders
Other - ecchymosis, light headedness and nausea
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
1.7%
4/229 • Number of events 4
|
|
Surgical and medical procedures
Hematoma
|
1.7%
4/229 • Number of events 4
|
0.00%
0/229
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
Other adverse events
| Measure |
V-Loc 180 / 90
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
|
Control - Monocryl 3-0
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
|
Midline
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm.
|
Non-protocol Incision or Systemic Events
n=229 participants at risk
Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Suture Extrusion
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
0.00%
0/229
|
0.00%
0/229
|
|
Infections and infestations
Wound Infection
|
3.9%
9/229 • Number of events 9
|
2.2%
5/229 • Number of events 5
|
2.6%
6/229 • Number of events 6
|
0.87%
2/229 • Number of events 2
|
|
Surgical and medical procedures
Hematoma
|
1.3%
3/229 • Number of events 3
|
1.3%
3/229 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Surgical and medical procedures
Granuloma
|
0.44%
1/229 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
0.00%
0/229
|
0.00%
0/229
|
|
Surgical and medical procedures
Wound Dehiscence
|
5.7%
13/229 • Number of events 13
|
4.4%
10/229 • Number of events 10
|
3.1%
7/229 • Number of events 7
|
3.9%
9/229 • Number of events 9
|
|
Surgical and medical procedures
Seroma
|
0.87%
2/229 • Number of events 2
|
0.00%
0/229
|
1.3%
3/229 • Number of events 3
|
2.6%
6/229 • Number of events 6
|
|
Surgical and medical procedures
Dermatitis
|
0.44%
1/229 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
0.00%
0/229
|
0.44%
1/229 • Number of events 1
|
|
Surgical and medical procedures
Incision Pain
|
1.7%
4/229 • Number of events 4
|
1.7%
4/229 • Number of events 4
|
0.00%
0/229
|
1.7%
4/229 • Number of events 4
|
|
Surgical and medical procedures
Edema
|
0.87%
2/229 • Number of events 2
|
0.87%
2/229 • Number of events 2
|
0.00%
0/229
|
3.9%
9/229 • Number of events 9
|
|
Surgical and medical procedures
Erythema
|
1.3%
3/229 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
1.3%
3/229 • Number of events 3
|
|
General disorders
Other - ecchymosis, light headedness and nausea
|
7.0%
16/229 • Number of events 16
|
2.6%
6/229 • Number of events 6
|
0.87%
2/229 • Number of events 2
|
24.9%
57/229 • Number of events 57
|
Additional Information
Amy Pollack M.D. Vice President Medical Affairs, STI
Covidien
Phone: 203-821-4719
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place