NCT05036785|CompletedResults
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Sponsor study identifier
interventional
60
1 country
1
Study Start
December 7, 2021
Actual (reported)Primary Completion
October 26, 2022
Actual (reported)Study Completion
October 26, 2022
Actual (reported)This is a single centre prospective randomized assessor blinded parallel group feasibility study that will be undertaken in the Royal Devon and Exeter Dermatology department. The investigators will be looking at whether timing of percutaneous suture removal after skin surgery impacts on the incidence of suture marks and overall scar cosmesis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 26, 2022
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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.
August 26, 2021
Actual (reported)September 8, 2021
Actual (reported)December 7, 2021
Actual (reported)October 26, 2022
Actual (reported)October 26, 2022
Actual (reported)October 24, 2024
Actual (reported)The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups
In patients undergoing wide local excision and primary wound closure for treatment of skin cancer does earlier removal of percutaneous sutures (7 days rather than 10 days) reduce the incidence of suture marks assessed at 3 months post-operatively. The patient and observer scar assessment scale (POSAS) was used. The patient POSAS was comprised of a score between 1-10 each for pain, itch, colour, stiffness, thickness and irregularity. The observer POSAS was comprised of a score between 1-10 each for vascularity, pigmentation, thickness, relief, pliability and surface area. 1 being normal skin and 10 abnormal skin. The total POSAS scores for both patients/observers were calculated by adding these up, with min/max 1-60. Higher scores equating to worse outcomes. A visual analogue scale (VAS) was used (min/max 1 to 10) to assess the appearance of suture marks, with 1 being normal skin and 10 being abnormal.
3 months
Does Earlier Suture Removal Have an Impact (Negative or Positive) on Overall Scar Cosmesis and Wound Complication Rates (as Assessed by the Clinician and the Patient)?
3 months
Suture removal at 7 days post skin surgery
Suture removal at 10 days post skin surgery
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Devon and Exeter Heavitree Hospital
Exeter, United Kingdom
Weitemeyer MB, Bramsen P, Klausen TW, Holmich LR, Gjorup CA. Patient-and observer-reported long-term scar quality of wide local excision scars in melanoma patients. J Plast Surg Hand Surg. 2018 Dec;52(6):319-324. doi: 10.1080/2000656X.2018.1493388. Epub 2018 Oct 31.
Prowse, Phoebe & Shokrollahi, Kayvan. (2014). Leaving our mark - are suture marks acceptable?. Bulletin of The Royal College of Surgeons of England. 96. 264-266. 10.1308/147363514X14042954768637.
CRIKELAIR GF. Skin suture marks. Am J Surg. 1958 Nov;96(5):631-9. doi: 10.1016/0002-9610(58)90464-1. No abstract available.
Emily McGrath, BMedSci BMBS
Royal Devon and Exeter NHS Trust
60 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2021
First Posted
September 8, 2021
Study Start
December 7, 2021
Actual (reported)Contact the study team to confirm eligibility.
Moy RL, Waldman B, Hein DW. A review of sutures and suturing techniques. J Dermatol Surg Oncol. 1992 Sep;18(9):785-95. doi: 10.1111/j.1524-4725.1992.tb03036.x.
Hasan Z, Gangopadhyay AN, Gupta DK, Srivastava P, Sharma SP. Sutureless skin closure with isoamyl 2-cyanoacrylate in pediatric day-care surgery. Pediatr Surg Int. 2009 Dec;25(12):1123-5. doi: 10.1007/s00383-009-2485-9. Epub 2009 Sep 17.
Hohenleutner U, Egner N, Hohenleutner S, Landthaler M. Intradermal buried vertical mattress suture as sole skin closure: evaluation of 149 cases. Acta Derm Venereol. 2000 Sep-Oct;80(5):344-7. doi: 10.1080/000155500459277.
Wolf R. Serial replacement of sutures for preventing suture marks. J Dermatol Surg Oncol. 1993 Dec;19(12):1131. doi: 10.1111/j.1524-4725.1993.tb02477.x. No abstract available.
Kobayashi S, Ito M, Yamamoto S, Kinugasa Y, Kotake M, Saida Y, Kobatake T, Yamanaka T, Saito N, Moriya Y. Randomized clinical trial of skin closure by subcuticular suture or skin stapling after elective colorectal cancer surgery. Br J Surg. 2015 Apr;102(5):495-500. doi: 10.1002/bjs.9786. Epub 2015 Feb 26.
Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.
Primary Completion
October 26, 2022
Actual (reported)Study Completion
October 26, 2022
Actual (reported)Last Updated
October 24, 2024
Results First Posted
October 24, 2024
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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