Timing of Suture Removal to Reduce Scarring in Skin Surgery

NCT05036785 | Completed Results

• 1 other identifier: 2011060
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suture Related Complication

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Suture removal at 7 days

ACTIVE COMPARATOR

Suture removal at 7 days post skin surgery

Other: Timing of suture removal

Suture removal at 10 days

ACTIVE COMPARATOR

Suture removal at 10 days post skin surgery

Other: Timing of suture removal

Interventions

Timing of suture removal OTHER

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 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 18 years old or above who had capacity to consent to surgery who were willing to attend follow-up appointments within the department
• 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

You may not qualify if:

• Inability to provide valid informed consent and/or unwilling to attend for follow-up
• 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.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon and Exeter Heavitree Hospital

Exeter, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 30380964 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 13583327 BACKGROUND

• 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.

  PMID: 1512311 BACKGROUND

• 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.

  PMID: 19760198 BACKGROUND

• 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.

  PMID: 11200831 BACKGROUND

• 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.

  PMID: 8282914 BACKGROUND

• 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.

  PMID: 25727933 BACKGROUND

• 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.

  PMID: 26146089 BACKGROUND

Results Point of Contact

• Title: Dr Ellen Richards
• Organization: Royal Devon and Exeter NHS Trust

ellen.richards6@nhs.net

01392 411611

Study Officials

• Emily McGrath, BMedSci BMBS

  Royal Devon and Exeter NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre prospective randomized assessor blinded parallel group feasibility study

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 8, 2021
• Study Start: December 7, 2021
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)