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Clinical Trials/NCT03303014
NCT03303014CompletedNot Applicable

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

University of California, Davis0 sites50 target enrollmentStarted: October 13, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Primary Endpoint
Patient Observer Scar Assessment Scale (POSAS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

5-0 Prolene

Experimental

Half of the wound will be treated with 5-0 prolene

Intervention: 5-0 Prolene, 5-0 Fast Absorbing Gut (Device)

5-0 Fast Absorbing Gut

Experimental

Half of the wound will be treated with 5-0 fast absorbing gut

Intervention: 5-0 Prolene, 5-0 Fast Absorbing Gut (Device)

Outcomes

Primary Outcomes

Patient Observer Scar Assessment Scale (POSAS)

Time Frame: 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 Outcomes

  • Width of the scar(within 3 months of the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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