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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture removal at 7 days | Active Comparator | Suture removal at 7 days post skin surgery |
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| Suture removal at 10 days | Active Comparator | Suture removal at 10 days post skin surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of suture removal | Other | Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)? | The impact on overall scar cosmesis was investigated using the POSAS score (results detailed above) and wound complications rates are detailed below for each group. | 3 months |
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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
Exclusion Criteria:
Inability to provide valid informed consent and/or unwilling to attend for follow-up
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| Name | Affiliation | Role |
|---|---|---|
| Emily McGrath, BMedSci BMBS | Royal Devon and Exeter NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Devon and Exeter Heavitree Hospital | Exeter | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30380964 | Background | 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. | |
| 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. | ||
| 13583327 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Suture Removal at 10 Days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | 3 months |
|
Each participant was monitored for adverse events up to 3 months after their procedure.
Patients were given direct contact to the department to voice any concerns over their wound healing. At their 3 month follow up, data was collected to determine whether they had been treated in primary or secondary care for infection/bleeding/dehiscence. This data was self reported by the patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ellen Richards | Royal Devon and Exeter NHS Trust | 01392 411611 | ellen.richards6@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2021 | Sep 1, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2021 | Sep 1, 2023 | ICF_001.pdf |
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Single centre prospective randomized assessor blinded parallel group feasibility study
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| 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. |
| 1512311 | 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. |
| 19760198 | 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. |
| 11200831 | 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. |
| 8282914 | 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. |
| 25727933 | 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. |
| 26146089 | 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. |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| 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 |
| OG001 | 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 |
|
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| 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)? | The impact on overall scar cosmesis was investigated using the POSAS score (results detailed above) and wound complications rates are detailed below for each group. | Posted | Number | participants | 3 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
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| Dehiscence |
|