Suture Related ComplicationNCT05036785
Timing of Suture Removal to Reduce Scarring in Skin Surgery
A study testing Timing of suture removal in people with Suture Related Complication, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suture Related Complication
- What is being tested?
- Timing of suture removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2021to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Suture Related Complication
- Being tested
- Timing of suture removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of suture removalOther
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
| Study group | Role | What they receive |
|---|---|---|
| Suture removal at 7 days | Active comparator | Suture removal at 7 days post skin surgery Receives: Other: Timing of suture removal |
| Suture removal at 10 days | Active comparator | Suture removal at 10 days post skin surgery Receives: Other: Timing of suture removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)?
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start7 Dec 2021
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Suture Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre prospective randomized assessor blinded parallel group feasibility study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily McGrath, BMedSci BMBS, Principal investigator, Royal Devon and Exeter NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036785
- Sponsor's protocol ID
- 2011060
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2021
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30380964Prowse, 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.
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.
PubMed 13583327Moy 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.
PubMed 1512311Hasan 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.
PubMed 19760198Hohenleutner 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.
PubMed 11200831Wolf 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.
PubMed 8282914Kobayashi 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.
PubMed 25727933Viechtbauer 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.
PubMed 26146089
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Suture Removal to Reduce Scarring in Skin Surgery
- ClinicalTrials.gov ID
- NCT05036785
- Acronym / sponsor ID
- 2011060
- Conditions
- Suture Related Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single centre prospective randomized assessor blinded parallel group feasibility study
| Arm | Type | Receives |
|---|---|---|
| Suture removal at 7 days | Active comparator | Other: Timing of suture removalSuture removal at 7 days post skin surgery |
| Suture removal at 10 days | Active comparator | Other: Timing of suture removalSuture removal at 10 days post skin surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to provide valid informed consent and/or unwilling to attend for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of suture removalPatients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery | Other | Suture removal at 10 days, Suture removal at 7 days |
Primary outcome
The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups
Time frame: 3 months
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30380964Weitemeyer 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.
- BackgroundProwse, 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: PubMed 13583327CRIKELAIR GF. Skin suture marks. Am J Surg. 1958 Nov;96(5):631-9. doi: 10.1016/0002-9610(58)90464-1. No abstract available.
- Background: PubMed 1512311Moy 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.
- Background: PubMed 19760198Hasan 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.
- Background: PubMed 11200831Hohenleutner 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.
- Background: PubMed 8282914Wolf 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.
- Background: PubMed 25727933Kobayashi 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.
- Background: PubMed 26146089Viechtbauer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily McGrath, BMedSci BMBS principal investigator
Royal Devon and Exeter NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of suture removal in people with Suture Related Complication, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036785, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.