Use of 6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Cutaneous Wound Closure: a Randomized Evaluator Blind Split Wound Comparative Effectiveness Trial.
Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
April 27, 2016
Actual (reported)Primary Completion
March 21, 2017
Actual (reported)Study Completion
April 16, 2019
Actual (reported)Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar. Other surgeons believe that using a thicker size of this stitch reduces the tension on the scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to determine whether the thickness of the fast absorbing gut suture that is used makes a difference in the cosmetic outcome of the scar.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 16, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2016
Actual (reported)March 21, 2017
Actual (reported)October 2, 2017
Actual (reported)October 5, 2017
Actual (reported)April 16, 2019
Actual (reported)Scar Assessment
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
3 months following the procedure
Width of the Scar
3 months following the procedure
6-0 fast absorbing gut used to suture wound
5-0 fast absorbing gut used to suture wound
Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0
Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0
Tajirian AL, Goldberg DJ. A review of sutures and other skin closure materials. J Cosmet Laser Ther. 2010 Dec;12(6):296-302. doi: 10.3109/14764172.2010.538413.
Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.
Gabrielli F, Potenza C, Puddu P, Sera F, Masini C, Abeni D. Suture materials and other factors associated with tissue reactivity, infection, and wound dehiscence among plastic surgery outpatients. Plast Reconstr Surg. 2001 Jan;107(1):38-45. doi: 10.1097/00006534-200101000-00007.
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
April 27, 2016
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van Rijssel EJ, Brand R, Admiraal C, Smit I, Trimbos JB. Tissue reaction and surgical knots: the effect of suture size, knot configuration, and knot volume. Obstet Gynecol. 1989 Jul;74(1):64-8.
Primary Completion
March 21, 2017
Actual (reported)Study Completion
April 16, 2019
Actual (reported)Last Updated
May 1, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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