Suturing Distance From the Wound Edge, 2 mm vs 5 mm
Primary Purpose
Cutaneous Sutures and Scar Cosmesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fast absorbing gut suture
Sponsored by
About this trial
This is an interventional other trial for Cutaneous Sutures and Scar Cosmesis focused on measuring Cutaneous Sutures, Scar Cosmesis, Linear Wound Closure, Wound Cosmesis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure on the trunk and extremities with predicted primary closure
- Willing to return for follow up visit.
Exclusion Criteria:
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Pregnant Women
- Wounds with predicted closure length less than 4 cm
Sites / Locations
- University of California, Davis, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fast absorbing gut suture placed 2 mm apart
Fast absorbing gut suture placed 5 mm apart
Arm Description
Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Outcomes
Primary Outcome Measures
Patient Posas Score
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.
Secondary Outcome Measures
Width of Scar
A secondary endpoint will include the width of the scar 1 cm from midline on each side.
This measurement will be reported in mm
Erythema
If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported
Full Information
NCT ID
NCT03330041
First Posted
October 26, 2017
Last Updated
April 20, 2021
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03330041
Brief Title
Suturing Distance From the Wound Edge, 2 mm vs 5 mm
Official Title
Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm) From Wound Edge on the Closure of Linear Wounds on the Head and Neck: a Randomized Evaluator Blinded Split Wound Comparative Effective Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
August 9, 2018 (Actual)
Study Completion Date
August 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter spacing between sutures.
Detailed Description
Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer. The deep layer dissolves naturally whereas the top layer may necessitate removal if non-absorbable sutures are used. This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter spacing between sutures. It is possible that fewer, more widely spaced sutures may leave more open space in the wound, leaving more tension to pull on those few sutures, possibly encouraging the wound to dehisce and make it harder to approximate the wound edges yielding a less cosmetically appealing scar compared to placing many closely approximated sutures which would decrease the tension and likely better approximate the wound edges yielding a more cosmetically appealing scar. On the other hand, the investigators may find that suture spacing has no effect on wound cosmesis and that placing fewer, more widely spaced sutures is much more time efficient. The investigators may also find that the effect of suture spacing on wound cosmesis is dependent on wound tension. For example, perhaps the suture pacing would have no effect on the cosmesis of a wound under no tension, however, for a wound under high tension, it is possible that many closely approximated sutures would yield better cosmetic results for the reasons listed above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Sutures and Scar Cosmesis
Keywords
Cutaneous Sutures, Scar Cosmesis, Linear Wound Closure, Wound Cosmesis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fast absorbing gut suture placed 2 mm apart
Arm Type
Experimental
Arm Description
Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Arm Title
Fast absorbing gut suture placed 5 mm apart
Arm Type
Experimental
Arm Description
Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Intervention Type
Device
Intervention Name(s)
Fast absorbing gut suture
Intervention Description
Fast absorbing surgical gut suture is a strand of collagenous material
Primary Outcome Measure Information:
Title
Patient Posas Score
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
Secondary Outcome Measure Information:
Title
Width of Scar
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
Title
Erythema
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Able to give informed consent themselves
Patient scheduled for cutaneous surgical procedure on the trunk and extremities with predicted primary closure
Willing to return for follow up visit.
Exclusion Criteria:
Mentally handicapped
Unable to understand written and oral English
Incarceration
Under 18 years of age
Pregnant Women
Wounds with predicted closure length less than 4 cm
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
University of California, Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30649154
Citation
Sklar LR, Pourang A, Armstrong AW, Dhaliwal SK, Sivamani RK, Eisen DB. Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck: A Randomized Clinical Trial. JAMA Dermatol. 2019 Mar 1;155(3):321-326. doi: 10.1001/jamadermatol.2018.5057.
Results Reference
derived
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Suturing Distance From the Wound Edge, 2 mm vs 5 mm
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