5-0 Prolene Versus 5-0 Fast Absorbing Gut

Study Overview
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Brief Summary
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When using suture (stitches) to close wounds, surgeons can use suture that is absorbable or non-absorbable. Absorbable sutures naturally break down. Non-absorbable sutures need to be removed. We wish to determine how the cosmetic result of a specific absorbable suture (fast absorbing gut) compares to that of a specific non-absorbable suture (prolene).

Detailed Description
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The purpose of this study is to determine whether the use of 5-0 prolene during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut (both SOC). We will use a split wound model, where half of the wound is treated with 5-0 prolene and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument (research procedure). The scar width and adverse events will be recorded. There are many options when it comes to closing a linear cutaneous wound, and an important consideration is choosing between non-absorbable and absorbable sutures. The overall aesthetic superiority between the two is not well understood. Studies to date have typically compared prolene (non-absorbable) and vicryl (absorbable) sutures and found no significant difference in cosmesis.1-4 One study found an increased pain score at 10 days with vicryl, but not at 6 weeks,1 while others have found no difference in pain.2-4 Another study found an increased number of complications with vicryl sutures, including infections and suture granulomas.4 This supports past observations that absorbable sutures can cause more of an immune response and therefore inflammation, despite the benefit of providing more prolonged support to wound edges compared to non-absorbable sutures.1 There is a lack of data, though, comparing prolene to other absorbable sutures, such as fast absorbing gut. In the setting of blepharoplasty, a study found that a running stitch of fast absorbing gut with a simple interrupted stitch of prolene at each end of the incision yielded better cosmetic results and fewer complications than a running stitch or subcuticular stitch using prolene.5 More studies are therefore needed to compare the outcomes of linear closures using only prolene compared to only fast absorbing gut. Using only absorbable sutures has the potential benefit of decreasing healthcare costs by reducing the number of appointments needed for suture removals, and, if superior in terms of cosmesis, corrective procedures.

Official Title
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Use of 5-0 Prolene Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

Conditions
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Cutaneous Wound

Intervention / Treatment
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* Device: 5-0 Prolene, 5-0 Fast Absorbing Gut


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: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-0 Prolene<br>Half of the wound will be treated with 5-0 prolene | Device: 5-0 Prolene, 5-0 Fast Absorbing Gut<br>* The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.<br>|
| Experimental: 5-0 Fast Absorbing Gut<br>Half of the wound will be treated with 5-0 fast absorbing gut | Device: 5-0 Prolene, 5-0 Fast Absorbing Gut<br>* The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Observer Scar Assessment Scale (POSAS) | The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit. | within 3 months of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Width of the scar | The secondary endpoint will include the width of the scar at the follow-up visit and any complications from the treatment. | within 3 months of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suture, Absorbable, Non-absorbable, Split wound, Cutaneous Wound