6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure
Primary Purpose
Surgical Wound Cosmesis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
6-0 fast absorbing gut suture
5-0 fast absorbing gut suture
Sponsored by
About this trial
This is an interventional other trial for Surgical Wound Cosmesis focused on measuring Cosmesis, Surgical Wound, Fast Absorbing Gut, Linear Cutaneous Wound
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure on the head and neck 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 3 cm
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
6-0 fast absorbing gut suture
5-0 fast absorbing gut suture
Arm Description
6-0 fast absorbing gut used to suture wound
5-0 fast absorbing gut used to suture wound
Outcomes
Primary Outcome Measures
Scar Assessment
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
Secondary Outcome Measures
Width of the Scar
The secondary endpoints will include the width of the scar 1 cm from midline on each side at the follow-up visit and any complications from the treatment.
Full Information
NCT ID
NCT03303027
First Posted
October 2, 2017
Last Updated
April 29, 2019
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03303027
Brief Title
6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure
Official Title
Use of 6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Cutaneous Wound Closure: a Randomized Evaluator Blind Split Wound Comparative Effectiveness Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 27, 2016 (Actual)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
April 16, 2019 (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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar. Other surgeons believe that using a thicker size of this stitch reduces the tension on the scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to determine whether the thickness of the fast absorbing gut suture that is used makes a difference in the cosmetic outcome of the scar.
Detailed Description
The purpose of this study is to determine whether the use of 6-0 fast absorbing gut during repair of linear cutaneous surgery wounds on the face or neck improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigator will use a split wound model, where half of the wound is repaired with 6-0 fast absorbing gut and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.
This study aims to investigate whether 5-0 versus 6-0 fast absorbing gut suture leads to better surgical wound cosmesis on the head and neck. The 5-0 fast absorbing gut suture has a large diameter, and therefore greater tensile strength. The greater tensile strength would provide better support of the healing scar during the first 5-7 days after surgery and for this reason, could potentially lead to improved scar cosmesis. However, the greater diameter could also lead to track marks that are larger and more visible. Furthermore, fast absorbing gut has a high degree of tissue reactivity to begin with, and it is known that larger diameter sutures generate more tissue reactivity compared to smaller diameter sutures of the same material; therefore, it is also possible that the 6-0 fast absorbing gut suture would provide better scar cosmesis by virtue of its lower tissue reactivity3,4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Cosmesis
Keywords
Cosmesis, Surgical Wound, Fast Absorbing Gut, Linear Cutaneous Wound
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6-0 fast absorbing gut suture
Arm Type
Experimental
Arm Description
6-0 fast absorbing gut used to suture wound
Arm Title
5-0 fast absorbing gut suture
Arm Type
Experimental
Arm Description
5-0 fast absorbing gut used to suture wound
Intervention Type
Device
Intervention Name(s)
6-0 fast absorbing gut suture
Intervention Description
Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0
Intervention Type
Device
Intervention Name(s)
5-0 fast absorbing gut suture
Intervention Description
Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0
Primary Outcome Measure Information:
Title
Scar Assessment
Description
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
Time Frame
3 months following the procedure
Secondary Outcome Measure Information:
Title
Width of the Scar
Description
The secondary endpoints will include the width of the scar 1 cm from midline on each side at the follow-up visit and any complications from the treatment.
Time Frame
3 months following the 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 head and neck 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 3 cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21142740
Citation
Tajirian AL, Goldberg DJ. A review of sutures and other skin closure materials. J Cosmet Laser Ther. 2010 Dec;12(6):296-302. doi: 10.3109/14764172.2010.538413.
Results Reference
background
PubMed Identifier
19465201
Citation
Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.
Results Reference
background
PubMed Identifier
11176599
Citation
Gabrielli F, Potenza C, Puddu P, Sera F, Masini C, Abeni D. Suture materials and other factors associated with tissue reactivity, infection, and wound dehiscence among plastic surgery outpatients. Plast Reconstr Surg. 2001 Jan;107(1):38-45. doi: 10.1097/00006534-200101000-00007.
Results Reference
background
PubMed Identifier
2543937
Citation
van Rijssel EJ, Brand R, Admiraal C, Smit I, Trimbos JB. Tissue reaction and surgical knots: the effect of suture size, knot configuration, and knot volume. Obstet Gynecol. 1989 Jul;74(1):64-8.
Results Reference
background
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6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure
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