Timing of Suture Removal to Reduce Scarring in Skin Surgery
Primary Purpose
Suture Related Complication
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Timing of suture removal
Sponsored by
About this trial
This is an interventional prevention trial for Suture Related Complication
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.
Sites / Locations
- Royal Devon and Exeter Heavitree Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Suture removal at 7 days
Suture removal at 10 days
Arm Description
Suture removal at 7 days post skin surgery
Suture removal at 10 days post skin surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)?
Full Information
NCT ID
NCT05036785
First Posted
August 26, 2021
Last Updated
April 19, 2023
Sponsor
Royal Devon and Exeter NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05036785
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Devon and Exeter NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suture Related Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single centre prospective randomized assessor blinded parallel group feasibility study
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suture removal at 7 days
Arm Type
Active Comparator
Arm Description
Suture removal at 7 days post skin surgery
Arm Title
Suture removal at 10 days
Arm Type
Active Comparator
Arm Description
Suture removal at 10 days post skin surgery
Intervention Type
Other
Intervention Name(s)
Timing of suture removal
Intervention Description
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
Primary Outcome Measure Information:
Title
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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)?
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily McGrath, BMedSci BMBS
Organizational Affiliation
Royal Devon and Exeter NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Devon and Exeter Heavitree Hospital
City
Exeter
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30380964
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
13583327
Citation
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.
Results Reference
background
PubMed Identifier
1512311
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.
Results Reference
background
PubMed Identifier
19760198
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.
Results Reference
background
PubMed Identifier
11200831
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.
Results Reference
background
PubMed Identifier
8282914
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.
Results Reference
background
PubMed Identifier
25727933
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.
Results Reference
background
PubMed Identifier
26146089
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.
Results Reference
background
Learn more about this trial
Timing of Suture Removal to Reduce Scarring in Skin Surgery
We'll reach out to this number within 24 hrs