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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

3 months following procedure

Results posted on

2026-03-13

Participant Flow

The surgeons recruited patients for the study from their cutaneous surgical practices.

Unit of analysis: Wound halves

Participant milestones

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

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

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 procedure

Population: 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

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 procedure

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

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 procedure

A secondary endpoint will include the width of the scar 1 cm from midline on each side

Outcome measures

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 procedure

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Vicryl Absorbable Suture Placed 1 cm Apart

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 916-551-2611

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place