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Suturing Distance From the Wound Edge, 2 mm vs 5 mm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330041
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : January 21, 2020
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Cutaneous Sutures and Scar Cosmesis
Intervention Device: Fast absorbing gut suture
Enrollment 50
Recruitment Details This randomized clinical trial was conducted at the University of California, Davis dermatology clinic from November 28, 2017, to June 15, 2018.
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description A split wound model was used, where half of the wound was repaired with sutures placed 2 millimeters apart and the other half is repaired with sutures placed 5 millimeters apart. A predetermined, concealed randomization number was obtained from the RedCap randomization module, which specified how Side A was treated. Side B was treated the opposite way as A.
Period Title: Overall Study
Started 50
Completed 48
Not Completed 2
Arm/Group Title Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart
Hide Arm/Group Description

Wound closed with sutures spaced 2 and 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
71.1  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
7
  14.0%
Male
43
  86.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
50
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Patient Posas Score
Hide Description Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin & 10 representing the most severe scar imaginable.
Time Frame 3 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fast Absorbing Gut Suture Placed 2 mm Apart Fast Absorbing Gut Suture Placed 5 mm Apart
Hide Arm/Group Description:

Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, running cuticular suture pattern.

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.

Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern.

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
10.2  (4.7) 11.5  (6.4)
2.Secondary Outcome
Title Width of Scar
Hide Description

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

This measurement will be reported in mm
Time Frame 3 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fast Absorbing Gut Suture Placed 2 mm Apart Fast Absorbing Gut Suture Placed 5 mm Apart
Hide Arm/Group Description:

Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, running cuticular suture pattern.

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.

Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern.

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: mm
0.9  (0.6) 0.8  (0.4)
3.Secondary Outcome
Title Erythema
Hide Description If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported
Time Frame 3 months following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fast Absorbing Gut Suture Placed 2 mm Apart Fast Absorbing Gut Suture Placed 5 mm Apart
Hide Arm/Group Description:

Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, running cuticular suture pattern.

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.

Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, running cuticular suture pattern.

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material.
Overall Number of Participants Analyzed 48 48
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame At 3-Month Follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fast Absorbing Gut Suture Placed 2 mm Apart Fast Absorbing Gut Suture Placed 5 mm Apart
Hide Arm/Group Description

Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material

Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern

Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material
All-Cause Mortality
Fast Absorbing Gut Suture Placed 2 mm Apart Fast Absorbing Gut Suture Placed 5 mm Apart
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Serious Adverse Events
Fast Absorbing Gut Suture Placed 2 mm Apart Fast Absorbing Gut Suture Placed 5 mm Apart
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fast Absorbing Gut Suture Placed 2 mm Apart Fast Absorbing Gut Suture Placed 5 mm Apart
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Eisen, M.D.
Organization: University of California, Davis, Department of Dermatology
Phone: 916-734-6479
EMail: dbeisen@ucdavis.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03330041    
Other Study ID Numbers: 1115596
First Submitted: October 26, 2017
First Posted: November 6, 2017
Results First Submitted: October 22, 2019
Results First Posted: January 21, 2020
Last Update Posted: May 12, 2021