One Week Versus Two Week Removal of Nylon Cutaneous Sutures for Linear Layered Closures on the Face: a Randomized Evaluator-blinded Prospective Split-scar Trial
Sponsor study identifier
interventional
68
1 country
1
Study Start
February 24, 2022
Actual (reported)Primary Completion
May 24, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 24, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Our goal is to compare the difference in surgical outcomes and patient satisfaction for surgical scars on the face between suture removal at 1 week versus 2 weeks. There is variation in the timing at which Mohs surgeons remove sutures on the face. Some prefer 1 week, and others prefer 2 weeks. This has not been formally studied. It is possible the outcomes are the same between both groups, or that one has a better cosmetic outcome than the other. Your skin cancer will be removed as usual. After this, your wound will be sutured in the usual fashion, except the top sutures will be divided into two separate halves. You will return at 1 week for one half of the top sutures to be removed, and at 2 weeks for the other half to be removed. Which half is removed first will be determined at random at your 1 week visit. At two months, you will return for standardized photographs which will be used by physicians to rate the cosmetic outcomes of the wound halves based on a standardized scale. Most likely, there will be no difference between the wound halves at 2 months and the study is complete. There is a small chance that there will be a cosmetic difference seen at 2 months, in which case you will return at 1 year for repeat standardized photographs and ratings. All data and photographs will be kept secure and any identifying information will be destroyed at the end of the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 24, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
February 24, 2022
Actual (reported)February 24, 2022
Actual (reported)March 4, 2022
Actual (reported)May 24, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 24, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Scar Cosmesis Assessment and Rating scale (SCAR) score
1\. Scar Cosmesis Assessment and Rating scale (SCAR), rated by three blinded observers based on digital photographs, with each half of the scar scored separately. This is a 0-13 rating with 0 representing the best possible scar.
2months (and possibly one year, see protocol)
pain level with suture removal
measured at 1 and 2 weeks after suture removal
difficulty of suture removal
measured at 1 and 2 weeks
Patient scar satisfaction
At 2 months
Patient preference for 1 vs 2 week suture removal.
Asked at 2 months
Presence of suture tracks
2 months
Cutaneous nylon suture removal of half of the split-scar at one week.
Cutaneous nylon suture removal of half of the split-scar at two weeks.
Cutaneous nylon suture removal of each half of the split-scar at one and two weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
DermSurgery Associates
Houston, Texas, 77030, United States
Eisen DB, Zhuang AR, Hasan A, Sharon VR, Bang H, Crispin MK. 5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial. Arch Dermatol Res. 2020 Apr;312(3):179-185. doi: 10.1007/s00403-019-02009-5. Epub 2019 Nov 13.
Yag-Howard C. Sutures, needles, and tissue adhesives: a review for dermatologic surgery. Dermatol Surg. 2014 Sep;40 Suppl 9:S3-S15. doi: 10.1097/01.DSS.0000452738.23278.2d.
Leonard H Goldberg, MD
DermSurgery Associates
First Submitted
February 24, 2022
First Posted
March 4, 2022
Study Start
February 24, 2022
Actual (reported)Handheld US Device to Verify Vascular Cannulation
Contact the study team to confirm eligibility.
Gal P, Toporcer T, Vidinsky B, Hudak R, Zivcak J, Sabo J. Simple interrupted percutaneous suture versus intradermal running suture for wound tensile strength measurement in rats: a technical note. Eur Surg Res. 2009;43(1):61-5. doi: 10.1159/000219214. Epub 2009 May 19.
Joo JS, Zhuang AR, Tchanque-Fossuo C, Tartar D, Armstrong AW, King TH, Sivamani RK, Eisen DB. Dermal suture only versus layered closure: A randomized, split wound comparative effectiveness trial. J Am Acad Dermatol. 2019 Dec;81(6):1346-1352. doi: 10.1016/j.jaad.2019.08.040. Epub 2019 Aug 21.
Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.
Primary Completion
May 24, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 24, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 4, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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