Timing of Suture Removal to Reduce Scarring in Skin Surgery
NCT ID: NCT05036785
Last Updated: 2024-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-12-07
2022-10-26
Brief Summary
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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.
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Detailed Description
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The investigators are conducting a single centre prospective randomized assessor blinded parallel group feasibility study to estimate a sample size required for a properly powered RCT, and also to provide some preliminary data on the incidence of wound complications and overall scar cosmesis in each group.
All patients attending the dermatology department for wide local excision as part of their skin cancer treatment and primary closure of the subsequent wound will be considered for entry into the trial. Clinicians will identify potential participants during routine practice at their clinic visit. Patients who fulfil the entry criteria will be invited at that appointment to take part.
On the date of participants skin surgery, they will be consented and randomized to either 'suture removal at 7 days' or 'suture removal at 10 days'. Participants will then be booked for a 3 month follow up where the scar site will be evaluated from a patient and clinician perspective to assess suture marks and overall cosmesis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Suture removal at 7 days
Suture removal at 7 days post skin surgery
Timing of suture removal
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
Suture removal at 10 days
Suture removal at 10 days post skin surgery
Timing of suture removal
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
Interventions
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Timing of suture removal
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing wide local excision as part of their skin cancer treatment pathway
* Lesions excised from the anterior chest or back
* Post-operative wound \>/= 10mm width
* Wound could be closed with primary intention healing
Exclusion Criteria
* Wounds where the edges could not be closely adhered with dermal sutures alone.
* Wounds requiring a flap or graft for closure.
* Patients requiring further treatment following original excision eg. Further WLE, radiotherapy etc.
18 Years
ALL
Yes
Sponsors
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Royal Devon and Exeter NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Emily McGrath, BMedSci BMBS
Role: PRINCIPAL_INVESTIGATOR
Royal Devon and Exeter NHS Trust
Locations
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Royal Devon and Exeter Heavitree Hospital
Exeter, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2011060
Identifier Type: -
Identifier Source: org_study_id
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