Clinical trial NCT05036785: Timing of Suture Removal to Reduce Scarring in Skin Surgery
Official title: Timing of Suture Removal to Reduce Scarring in Skin Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture Related Complication
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre prospective randomized assessor blinded parallel group feasibility study
Primary purpose: PREVENTION

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.

Detailed description: Stitch marks (also known as suture marks or track marks) are permanent marks left in the skin where the stitch has caused local tissue damage and scarring. The risk of these marks is in part thought to be related to the length of time that the stitches are left in place before removal. Stitches are normally left in place for longer on sites where the skin is under greater tension such as the chest or back because there is a concern that the wound may be more likely to open up on these sites. On the chest or back, stitches may be left in place for up to 14 days even though the chest or back is a common site for stitch marks to form.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups
timeFrame: 3 months
Secondary outcomes:
measure: 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)?
timeFrame: 3 months
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Heavitree Hospital
Study officials:
affiliation: Royal Devon and Exeter NHS Trust
name: Emily McGrath, BMedSci BMBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.