6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Surgical Wound Cosmesis

Intervention / Treatment
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* Device: 6-0 fast absorbing gut suture
* Device: 5-0 fast absorbing gut suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6-0 fast absorbing gut suture<br>6-0 fast absorbing gut used to suture wound | Device: 6-0 fast absorbing gut suture<br>* Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0<br>|
| Experimental: 5-0 fast absorbing gut suture<br>5-0 fast absorbing gut used to suture wound | Device: 5-0 fast absorbing gut suture<br>* Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months following the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmesis, Surgical Wound, Fast Absorbing Gut, Linear Cutaneous Wound