Trial Outcomes & Findings for Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis (NCT NCT03327922)
NCT ID: NCT03327922
Last Updated: 2026-03-13
Results Overview
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.
COMPLETED
NA
50 participants
3 months following procedure
2026-03-13
Participant Flow
The surgeons recruited patients for the study from their cutaneous surgical practices.
Unit of analysis: Wound halves
Participant milestones
| Measure |
Vicryl Absorbable Suture Placed 2 cm Apart
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Vicryl Absorbable Suture Placed 1 cm Apart
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
|---|---|---|
|
Overall Study
STARTED
|
50 50
|
50 50
|
|
Overall Study
COMPLETED
|
46 46
|
46 46
|
|
Overall Study
NOT COMPLETED
|
4 4
|
4 4
|
Reasons for withdrawal
| Measure |
Vicryl Absorbable Suture Placed 2 cm Apart
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Vicryl Absorbable Suture Placed 1 cm Apart
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis
Baseline characteristics by cohort
| Measure |
Vicryl Absorbable Suture Placed 2 cm Apart
n=50 Wound halves
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Vicryl Absorbable Suture Placed 1 cm Apart
n=50 Wound halves
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Total
n=100 Wound halves
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 7.7 • n=10 Wound halves
|
70.2 years
STANDARD_DEVIATION 7.7 • n=10 Wound halves
|
70.2 years
STANDARD_DEVIATION 7.7 • n=20 Wound halves
|
|
Sex: Female, Male
Female
|
11 Wound halves
n=10 Wound halves
|
11 Wound halves
n=10 Wound halves
|
22 Wound halves
n=20 Wound halves
|
|
Sex: Female, Male
Male
|
39 Wound halves
n=10 Wound halves
|
39 Wound halves
n=10 Wound halves
|
78 Wound halves
n=20 Wound halves
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=20 Wound halves
|
|
Race (NIH/OMB)
Asian
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=20 Wound halves
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=20 Wound halves
|
|
Race (NIH/OMB)
Black or African American
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=20 Wound halves
|
|
Race (NIH/OMB)
White
|
50 Wound halves
n=10 Wound halves
|
50 Wound halves
n=10 Wound halves
|
100 Wound halves
n=20 Wound halves
|
|
Race (NIH/OMB)
More than one race
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=20 Wound halves
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=20 Wound halves
|
|
Closure Length
|
5.89 centimeters
STANDARD_DEVIATION 1.2 • n=10 Wound halves
|
5.89 centimeters
STANDARD_DEVIATION 1.2 • n=10 Wound halves
|
5.89 centimeters
STANDARD_DEVIATION 1.2 • n=20 Wound halves
|
|
Location of Surgical Procedure
Cheeks
|
18 Wound halves
n=10 Wound halves
|
18 Wound halves
n=10 Wound halves
|
36 Wound halves
n=20 Wound halves
|
|
Location of Surgical Procedure
Chin
|
1 Wound halves
n=10 Wound halves
|
1 Wound halves
n=10 Wound halves
|
2 Wound halves
n=20 Wound halves
|
|
Location of Surgical Procedure
Forehead
|
6 Wound halves
n=10 Wound halves
|
6 Wound halves
n=10 Wound halves
|
12 Wound halves
n=20 Wound halves
|
|
Location of Surgical Procedure
Neck
|
11 Wound halves
n=10 Wound halves
|
11 Wound halves
n=10 Wound halves
|
22 Wound halves
n=20 Wound halves
|
|
Location of Surgical Procedure
Pre-auricular
|
8 Wound halves
n=10 Wound halves
|
8 Wound halves
n=10 Wound halves
|
16 Wound halves
n=20 Wound halves
|
|
Location of Surgical Procedure
Post-auricular
|
1 Wound halves
n=10 Wound halves
|
1 Wound halves
n=10 Wound halves
|
2 Wound halves
n=20 Wound halves
|
|
Location of Surgical Procedure
Temple
|
5 Wound halves
n=10 Wound halves
|
5 Wound halves
n=10 Wound halves
|
10 Wound halves
n=20 Wound halves
|
|
Surgeon Experience
Fellow
|
32 Wound halves
n=10 Wound halves
|
32 Wound halves
n=10 Wound halves
|
64 Wound halves
n=20 Wound halves
|
|
Surgeon Experience
Attending
|
17 Wound halves
n=10 Wound halves
|
17 Wound halves
n=10 Wound halves
|
34 Wound halves
n=20 Wound halves
|
|
Surgeon Experience
Resident
|
1 Wound halves
n=10 Wound halves
|
1 Wound halves
n=10 Wound halves
|
2 Wound halves
n=20 Wound halves
|
|
Indication for Surgery
Mohs
|
50 Wound halves
n=10 Wound halves
|
50 Wound halves
n=10 Wound halves
|
100 Wound halves
n=20 Wound halves
|
|
Indication for Surgery
Excision
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=10 Wound halves
|
0 Wound halves
n=20 Wound halves
|
PRIMARY outcome
Timeframe: 3 months following procedurePopulation: Out of 46 patients, each patient's wound was then divided into 2 sides: A and B. An intervention was randomly assigned to each side of the wound, for a total of 92 wound halves.
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.
Outcome measures
| Measure |
Vicryl Absorbable Suture Placed 2 cm Apart
n=46 wound halves
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Vicryl Absorbable Suture Placed 1 cm Apart
n=46 wound halves
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
|---|---|---|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Sum of Observer POSAS
|
13.14 score on a scale
Interval 8.0 to 28.0
|
12.40 score on a scale
Interval 8.0 to 32.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Vascularity
|
2.46 score on a scale
Interval 1.0 to 6.0
|
2.23 score on a scale
Interval 1.0 to 6.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Pigmentation
|
2.07 score on a scale
Interval 1.0 to 4.0
|
1.96 score on a scale
Interval 1.0 to 5.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Thickness
|
2.52 score on a scale
Interval 1.0 to 6.0
|
2.34 score on a scale
Interval 1.0 to 6.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Relief
|
2.56 score on a scale
Interval 1.0 to 8.0
|
2.36 score on a scale
Interval 1.0 to 5.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Pliability
|
2.67 score on a scale
Interval 1.0 to 5.0
|
2.73 score on a scale
Interval 1.0 to 7.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Surface Area
|
2.62 score on a scale
Interval 1.0 to 7.0
|
2.43 score on a scale
Interval 1.0 to 7.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 1
Overall Opinion
|
2.84 score on a scale
Interval 1.0 to 7.0
|
2.66 score on a scale
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: 3 months following procedureThe primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.
Outcome measures
| Measure |
Vicryl Absorbable Suture Placed 2 cm Apart
n=46 Wound halves
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Vicryl Absorbable Suture Placed 1 cm Apart
n=46 Wound halves
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
|---|---|---|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Sum of POSAS
|
14.63 score on a scale
Interval 6.0 to 33.0
|
13.33 score on a scale
Interval 6.0 to 27.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Pain
|
1.02 score on a scale
Interval 1.0 to 2.0
|
1.00 score on a scale
Interval 1.0 to 1.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Itching
|
1.13 score on a scale
Interval 1.0 to 6.0
|
1.07 score on a scale
Interval 1.0 to 3.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Color
|
3.00 score on a scale
Interval 1.0 to 8.0
|
2.78 score on a scale
Interval 1.0 to 8.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Stiffness
|
2.85 score on a scale
Interval 1.0 to 9.0
|
2.67 score on a scale
Interval 1.0 to 8.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Thickness
|
2.44 score on a scale
Interval 1.0 to 8.0
|
2.24 score on a scale
Interval 1.0 to 8.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Irregularity
|
2.94 score on a scale
Interval 1.0 to 10.0
|
2.59 score on a scale
Interval 1.0 to 10.0
|
|
Patient and Observer Scar Assessment Scale - Reviewer 2
Overall opinion
|
2.85 score on a scale
Interval 1.0 to 8.0
|
2.44 score on a scale
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: 3 months following procedureA secondary endpoint will include the width of the scar 1 cm from midline on each side
Outcome measures
| Measure |
Vicryl Absorbable Suture Placed 2 cm Apart
n=46 wound halves
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Vicryl Absorbable Suture Placed 1 cm Apart
n=46 wound halves
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
|---|---|---|
|
Width of Scar
|
1.47 cm
Interval 0.5 to 3.0
|
1.25 cm
Interval 0.5 to 3.0
|
SECONDARY outcome
Timeframe: 3 months following procedurePopulation: Out of 46 patients, each patient's wound was then divided into 2 sides: A and B. An intervention was randomly assigned to each side of the wound, for a total of 92 wound halves.
Any complications including suture reaction, dehiscence, infection, necrosis, bleeding, and hematoma
Outcome measures
| Measure |
Vicryl Absorbable Suture Placed 2 cm Apart
n=46 Wound halves
Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
Vicryl Absorbable Suture Placed 1 cm Apart
n=46 Wound halves
Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern
Vicryl absorbable suture: Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
|
|---|---|---|
|
Complications
Dehiscence
|
1 Wound halves
|
2 Wound halves
|
|
Complications
Suture Abscess
|
10 Wound halves
|
7 Wound halves
|
Adverse Events
Vicryl Absorbable Suture Placed 2 cm Apart
Vicryl Absorbable Suture Placed 1 cm Apart
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Daniel B. Eisen
Department of Dermatology, UC Davis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place