5-0 Prolene Versus 5-0 Fast Absorbing Gut

Not Applicable

Completed

• Conditions: Cutaneous Wound
• Interventions: Device: 5-0 Prolene, 5-0 Fast Absorbing Gut

• Registration Number: NCT03303014
• Lead Sponsor: University of California, Davis

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-10-13
• Primary Completion: 2016-03-15
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-05
• Study Completion: 2019-10-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
5-0 Fast Absorbing Gut	5-0 Prolene, 5-0 Fast Absorbing Gut	Half of the wound will be treated with 5-0 fast absorbing gut
5-0 Prolene	5-0 Prolene, 5-0 Fast Absorbing Gut	Half of the wound will be treated with 5-0 prolene

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Width of the scar	within 3 months of the procedure	The secondary endpoint will include the width of the scar at the follow-up visit and any complications from the treatment.