5-0 Prolene Versus 5-0 Fast Absorbing Gut
Primary Purpose
Cutaneous Wound
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
5-0 Prolene, 5-0 Fast Absorbing Gut
Sponsored by
About this trial
This is an interventional other trial for Cutaneous Wound focused on measuring Suture, Absorbable, Non-absorbable, Split wound, 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
5-0 Prolene
5-0 Fast Absorbing Gut
Arm Description
Half of the wound will be treated with 5-0 prolene
Half of the wound will be treated with 5-0 fast absorbing gut
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03303014
First Posted
October 2, 2017
Last Updated
April 20, 2021
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03303014
Brief Title
5-0 Prolene Versus 5-0 Fast Absorbing Gut
Official Title
Use of 5-0 Prolene Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2015 (Actual)
Primary Completion Date
March 15, 2016 (Actual)
Study Completion Date
October 1, 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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Wound
Keywords
Suture, Absorbable, Non-absorbable, Split wound, Cutaneous Wound
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5-0 Prolene
Arm Type
Experimental
Arm Description
Half of the wound will be treated with 5-0 prolene
Arm Title
5-0 Fast Absorbing Gut
Arm Type
Experimental
Arm Description
Half of the wound will be treated with 5-0 fast absorbing gut
Intervention Type
Device
Intervention Name(s)
5-0 Prolene, 5-0 Fast Absorbing Gut
Intervention Description
The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.
Primary Outcome Measure Information:
Title
Patient Observer Scar Assessment Scale (POSAS)
Description
The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.
Time Frame
within 3 months of the procedure
Secondary Outcome Measure Information:
Title
Width of the scar
Description
The secondary endpoint will include the width of the scar at the follow-up visit and any complications from the treatment.
Time Frame
within 3 months of 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
270137
Citation
Zemla J. [Plastic operation of the alveolar process and associated deformities of the middle part of the face after primary operations for bilateral complete clefts of the lip, alveolar process and palate]. Protet Stomatol. 1977 Mar-Apr;27(2):143-4. No abstract available. Polish.
Results Reference
background
PubMed Identifier
11281671
Citation
Erel E, Pleasance PI, Ahmed O, Hart NB. Absorbable versus non-absorbable suture in carpal tunnel decompression. J Hand Surg Br. 2001 Apr;26(2):157-8. doi: 10.1054/jhsb.2000.0545.
Results Reference
background
PubMed Identifier
21987279
Citation
Theopold C, Potter S, Dempsey M, O'Shaughnessy M. A randomised controlled trial of absorbable versus non-absorbable sutures for skin closure after open carpal tunnel release. J Hand Surg Eur Vol. 2012 May;37(4):350-3. doi: 10.1177/1753193411422334. Epub 2011 Oct 10.
Results Reference
background
PubMed Identifier
15368623
Citation
Menovsky T, Bartels RH, van Lindert EL, Grotenhuis JA. Skin closure in carpal tunnel surgery: a prospective comparative study between nylon, polyglactin 910 and stainless steel sutures. Hand Surg. 2004 Jul;9(1):35-8. doi: 10.1142/s0218810404002017.
Results Reference
background
PubMed Identifier
17545862
Citation
Joshi AS, Janjanin S, Tanna N, Geist C, Lindsey WH. Does suture material and technique really matter? Lessons learned from 800 consecutive blepharoplasties. Laryngoscope. 2007 Jun;117(6):981-4. doi: 10.1097/MLG.0b013e31804f54bd. Erratum In: Laryngoscope. 2007 Aug;117(8):1510. Lindsey, Charlie [corrected to Lindsey, William H].
Results Reference
background
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5-0 Prolene Versus 5-0 Fast Absorbing Gut
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