Timing of Suture Removal to Reduce Scarring in Skin Surgery

Suture Related Complication Clinical Trial

Official title:

Timing of Suture Removal to Reduce Scarring in Skin Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036785
• Other study ID #: 2011060
• Status: Completed
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: October 26, 2022

Study information

• Verified date: October 2022
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix
• Suture Related Complication

Intervention

Other:
• Timing of suture removal
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery

Locations

Country	Name	City	State
United Kingdom	Royal Devon and Exeter Heavitree Hospital	Exeter

Sponsors (1)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View 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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months
Secondary	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