NCT03303014|Completed
5-0 Prolene Versus 5-0 Fast Absorbing Gut
Use of 5-0 Prolene Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
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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
Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
October 13, 2015
Actual (reported)Primary Completion
March 15, 2016
Actual (reported)Study Completion
October 1, 2019
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2015
Actual (reported)March 15, 2016
Actual (reported)October 2, 2017
Actual (reported)October 5, 2017
Actual (reported)October 1, 2019
Actual (reported)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
Width of the scar
within 3 months of the procedure
Half of the wound will be treated with 5-0 prolene
Half of the wound will be treated with 5-0 fast absorbing gut
The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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.
Daniel Eisen, MD
University of California, Davis
50 participants (actual enrollment reported by the registry).
First Submitted
October 2, 2017
First Posted
October 5, 2017
Study Start
October 13, 2015
Actual (reported)Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
March 15, 2016
Actual (reported)Study Completion
October 1, 2019
Actual (reported)Last Updated
April 22, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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