Set-back Suture Versus Traditional Vertical Mattress Suture
Primary Purpose
Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Set-back suture
Vertical mattress suture
Sponsored by
About this trial
This is an interventional supportive care trial for Basal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Elliptical surgical wound that needs to be closed with a layered closure
- Wound 3 cm in length or longer
Exclusion Criteria:
- Incarceration
- Active pregnancy
- Less than 18 years of age
- Unable to give informed consent
- Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
- Wound closure projected to be less than 3 cm in length
- Skin less than 3 mm in thickness (dermis and epidermis combined)
Sites / Locations
- UC Davis, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Set-back suture
Vertical mattress suture technique
Arm Description
Wound to be close by set-back suture technique.
Wound to be closed by vertical mattress technique.
Outcomes
Primary Outcome Measures
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
Compare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows:
a. Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.
Scar width
Width of scar in millimeters for each side of scar measured 1 cm from the midline.
Secondary Outcome Measures
Height of scar immediately following wound closure
Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters
Full Information
NCT ID
NCT01773447
First Posted
January 15, 2013
Last Updated
March 29, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01773447
Brief Title
Set-back Suture Versus Traditional Vertical Mattress Suture
Official Title
Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Set-back suture
Arm Type
Active Comparator
Arm Description
Wound to be close by set-back suture technique.
Arm Title
Vertical mattress suture technique
Arm Type
Active Comparator
Arm Description
Wound to be closed by vertical mattress technique.
Intervention Type
Procedure
Intervention Name(s)
Set-back suture
Intervention Type
Procedure
Intervention Name(s)
Vertical mattress suture
Primary Outcome Measure Information:
Title
Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
Description
Compare the functional and cosmetic outcomes of the two sutured halves of each scar at 3 months follow-up as follows:
a. Use a previously validated scar assessment scale called the Patient and Observer Scar Assessment Scale, specifically the averaged sum of the total score of 2 blinded observers.
Time Frame
3 months
Title
Scar width
Description
Width of scar in millimeters for each side of scar measured 1 cm from the midline.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Height of scar immediately following wound closure
Description
Height of each side of the wound will be measured 1 cm from the midpoint of the wound in millimeters
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elliptical surgical wound that needs to be closed with a layered closure
Wound 3 cm in length or longer
Exclusion Criteria:
Incarceration
Active pregnancy
Less than 18 years of age
Unable to give informed consent
Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
Wound closure projected to be less than 3 cm in length
Skin less than 3 mm in thickness (dermis and epidermis combined)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research
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Set-back Suture Versus Traditional Vertical Mattress Suture
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