Timing of Suture Removal to Reduce Scarring in Skin Surgery
Phase: NA
Conditions: Suture Related Complication
Sponsor: Royal Devon and Exeter NHS Foundation Trust

 
 
 
 
Royal Devon and Exeter 
 
 
NHS Foundation Trust 
 
Timing of Suture Removal to Reduce Scarring in Skin Surgery 
 
Version 2: 19th September 2021 
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Timing of Suture Removal to Reduce Scarring 
in Skin Surgery 
 
 
 
 
 
 
 
 
 
 
End Date 26th October 2022 
 
IRAS Number: 303519 
 
Sponsor: Royal Devon and Exeter NHS Trust 
 
Chief Investigator: 
Dr Emily McGrath, Consultant Dermatologist, Royal Devon and Exeter NHS Trust 
 
Co-Principle Investigators: 
Dr Alistair Brown, Dermatology Registrar, Royal Devon and Exeter NHS Trust 
Dr Ellen Richards, Academic Foundation Doctor, Royal Devon and Exeter NHS Trust 

 
 
 
 
Royal Devon and Exeter 
 
 
NHS Foundation Trust 
 
Timing of Suture Removal to Reduce Scarring in Skin Surgery 
 
Version 2: 19th September 2021 
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1. HRA PROTOCOL COMPLIANCE DECLARATION 
 
 
The undersigned confirm that the following protocol has been agreed and accepted and that the 
Chief Investigator agrees to conduct the study in compliance with the approved protocol and will 
adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other 
regulatory requirement. 
 
I agree to ensure that the confidential information contained in this document will not be used for 
any other purpose other than the evaluation or conduct of the investigation without the prior 
written consent of the Sponsor 
 
I also confirm that I will make the findings of the study publically available through publication or 
other dissemination tools without any unnecessary delay and that an honest accurate and 
transparent account of the study will be given; and that any discrepancies from the study as planned 
in this protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
...................................................................................................... 
 
 
Position: 
...................................................................................................... 
 
 
 
 
Chief Investigator: 
Signature: 
...................................................................................................... 
 
Date: 
....../....../...... 
Name: (please print): 
...................................................................................................... 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
Royal Devon and Exeter 
 
 
NHS Foundation Trust 
 
Timing of Suture Removal to Reduce Scarring in Skin Surgery 
 
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2. CONTENTS 
 
GENERAL INFORMATION 
 
 
 
 
 
 
 
PAGE 
1. HRA PROTOCOL COMPLIANCE DECLARATION 
 
 
 
 
2 
2. CONTENTS 
 
 
 
 
 
 
 
 
3-4 
3. KEY STUDY CONTACTS  
 
 
 
 
 
 
5 
4. STUDY SUMMARY 
 
 
 
 
 
 
 
5 
5. FUNDING 
 
 
 
 
 
 
 
 
5-6 
6. ROLE OF SPONSOR AND FUNDER 
 
 
 
 
 
6 
7. PROJECT MANAGEMENT 
 
 
 
 
 
 
6-7 
8. TIMELINE 
 
 
 
 
 
 
 
 
7 
9. STUDY FLOW CHART 
 
 
 
 
 
 
 
8 
 
PROTOCOL 
 
 
 
 
 
 
 
 
 
PAGE 
 
 
 
 
 
 
 
10. BACKGROUND   
 
 
 
 
 
 
 
10 
11. RATIONALE & LITERATURE REVIEW 
 
 
 
 
 
10-11 
12. THEORETICAL FRAMEWORK 
 
 
 
 
 
 
11 
13. RESEARCH QUESTION  
 
 
 
 
 
 
11-12 
14. AIMS AND OBJECTIVES  
 
 
 
 
 
 
12 
15. LAY SUMMARY  
 
 
 
 
 
 
 
12-13 
16. STUDY DESIGN  
 
 
 
 
 
 
 
13 
16.1 Study Setting, Population and Patient Identification 
 
 
 
13 
16.2 Data Collection Prior to Surgery 
 
 
 
 
 
14 
16.3 Surgical Procedure 
 
 
 
 
 
 
 
14 
16.4 Randomization and Blinding  
 
 
 
 
 
14-15 
16.5 Wound Dressing and Post-operative Care 
 
 
 
 
15 
16.6 Data Collection at 3 Month Follow Up  
 
 
 
 
16 
17. DATA ANALYSIS AND METHODS 
 
 
 
 
 
16-17 
18. SAMPLE AND RECRUITMENT 
 
 
 
 
 
 
17 
18.1 Study Population, Sampling and Recruitment  
 
 
 
17 
18.2 Inclusion Criteria 
 
 
 
 
 
 
 
17 
18.3 Exclusion Criteria 
 
 
 
 
 
 
 
17 
18.4 Sample Size 
 
 
 
 
 
 
 
 
18 
18.5 Sample Identification  
 
 
 
 
 
 
18 
18.6 Consent 
 
 
 
 
 
 
 
 
18-19 
19. ETHICAL AND REGULATORY COMPLIANCE 
 
 
 
 
19 

 
 
 
 
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19.1 Patient Safety and Serious Adverse Events 
 
 
 
 
19-20 
19.2 Assessment and Management of Risk  
 
 
 
 
20 
19.3 Quality Assurance 
 
 
 
 
 
 
 
20 
19.4 Research Ethics Committee (REC) Review and Reports  
 
 
20 
19.5 Amendments  
 
 
 
 
 
 
 
20 
19.6 Protocol Compliance  
 
 
 
 
 
 
20 
19.7 Data Protection and Confidentiality 
 
 
 
 
 
21 
19.8 Access to the Final Study Data Set 
 
 
 
 
 
21 
20. DISSEMINATION POLICY 
 
 
 
 
 
 
21 
20.1 Authorship 
 
 
 
 
 
 
 
 
21 
21. REFERENCES 
 
 
 
 
 
 
 
 
22 
22. APPENDICIES 
 
 
 
 
 
 
 
 
22 
22.1 Appendix 1 – Required Documentation 
 
 
 
 
22 
22.2 Appendix 2 – Amendment History 
 
 
 
 
 
22-23 
22.3 Appendix 3 – CV of Chief Investigator (Dr Emily McGrath) 
 
 
23-25 
22.4 Appendix 4 – CV of Co-Principle Investigator (Dr Ellen Richards) 
 
26-28 
22.5 Appendix 5 – CV of Co-Principle Investigator (Dr Alistair Brown) 
 
28-35 
22.6 Appendix 6 – Patient Information Sheet 
 
 
 
 
36-46 
22.7 Appendix 7 – Patient Informed Consent Form  
 
 
 
47 
22.8 Appendix 8 – Data Collection Form 
 
 
 
 
 
48-49 
22.9 Appendix 9 – POSAS Observer Scale 
 
 
 
 
 
50 
22.10 Appendix 10 – POSAS Patient Scale 
 
 
 
 
 
51 
22.11 Appendix 11 – Numerical Visual Analogue Scale (VAS)  
 
 
52 
22.12 Appendix 12 – GP letter 
 
 
 
 
 
 
53 
22.13 Appendix 13 – Suture Removal Standard Operating Procedure (SOP) 
 
54-55 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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3. KEY STUDY CONTACTS 
 
 
Chief Investigator 
Dr Emily McGrath 
Consultant Dermatologist 
Royal Devon and Exeter NHS Trust 
Emily.mcgrath@nhs.net 
Study Co-ordinators 
Dr Ellen Richards 
Academic Foundation Doctor 
Royal Devon and Exeter NHS Trust 
Ellen.richards6@nhs.net 
 
Dr Alistair Brown 
Dermatology Registrar 
Royal Devon and Exeter NHS Trust 
Alistair.brown4@nhs.net 
Sponsor 
Royal Devon and Exeter NHS Trust 
Funder 
Dermatology Department 
Royal Devon and Exeter NHS Trust 
 
4. STUDY SUMMARY 
 
Study Title 
Timing of Suture Removal to Reduce Scarring in Skin 
Surgery 
Study Design 
Prospective randomized assessor blinded parallel 
group feasibility study 
Planned Size of Sample  
60 
Follow up duration  
3 months 
Research Question/Aim(s) 
 
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. 
 
5. FUNDING 
 
FUNDER 
FINANCIAL AND NON FINANCIAL SUPPORT GIVEN 
Dermatology Department 
Royal Devon and Exeter NHS Trust 
Heavitree Hospital 
Financial support for printing patient information 
sheets and other required documentation. 
Facilitating space for clinic follow-up. 

 
 
 
 
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Gladstone Road 
Exeter 
EX1 2ED 
 
Support of the dermatology team helping with 
recruitment to trial. 
Royal Devon and Exeter NHS Trust 
Barrack Road, Exeter, EX2 5DW 
Support in the form of allocation of an academic 
foundation doctor as co-principle investigator.  
 
6. ROLE OF SPONSOR AND FUNDER 
 
Sponsor: Royal Devon and Exeter NHS Trust 
 
Role of Sponsor:  
• 
To take overall responsibility for the research 
• 
Ensuring appropriate indemnity or insurance for the study 
• 
Ensuring patient/participant safety and rights 
 
Role of Funder: 
• 
To aid in financial support for printing and dissemination of patient information sheets and 
postage of trial information to participants 
• 
To provide healthcare professionals within the dermatology department to help with 
execution of patient recruitment and follow-up 
 
7. PROJECT MANAGEMENT 
 
Dr Emily McGrath 
Consultant Dermatologist 
Royal Devon and Exeter NHS Trust 
Primary responsibility for conduct of trial 
Adverse event assessment 
Responsible for concealment of patient 
randomization 
Trial recruitment and consent 
Protocol contributor 
Dr Ellen Richards 
Academic Foundation Doctor 
Royal Devon and Exeter NHS Trust 
Initiation and conduct of trial 
Day to day running of project 
Reporting of adverse events 
Maintenance of regulatory documents and 
spreadsheet 
Review of patients at 3-month follow-up 
Study write-up 
Protocol contributor 
Dr Alistair Brown 
Dermatology Registrar 
Royal Devon and Exeter NHS Trust 
Initiation and conduct of trial 
Data analysis 
Study write-up 
Protocol contributor 
Dr Roy Powell 
Protocol contributor 

 
 
 
 
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Research Statistician  
Royal Devon and Exeter NHS Trust 
All doctors within the dermatology department 
Trial recruitment and consent 
Data collection prior to procedure 
Data collection in theatre 
 
8. TIMELINE 
 
Months 
 
0 
3-6 
6-12 
12-15 
Finalize protocol 
x 
 
 
 
Ethics submission 
x 
 
 
 
Patient recruitment 
 
x 
 
 
3 month follow-up 
 
 
x 
 
Data entry 
 
 
x 
 
Data analysis 
 
 
 
x 
Project write up 
 
 
 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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9. STUDY FLOW CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient attendance at clinic. 
Decision to perform wide 
local excision as part of skin 
cancer treatment pathway
Patient informed of 
opportunity to enroll in study 
and provided with trial 
information leaflet 
Patient booked for surgery, 
telephone call to advise date of 
surgery. Invited to take part in 
the study
Patient to be contacted by a 
member of the research 
team before surgery for an 
opportunity to discuss the 
trial further and invited to 
join. Verbal consent gained
Formal written consent gained at 
time of surgery by member of 
the research team
Surgery performed as per 
protocol
Patient leaves the room with 
nurse for randomization, 
nurse opens envelope with 
trial allocation arm  
Appointment is booked with GP 
or in the department for suture 
removal at either 7 or 10 days
Follow-up at 3 months with 
wound review
OR 

 
 
 
 
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Timing of Suture Removal to Reduce Scarring 
in Skin Surgery 
 
 
Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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10. 
BACKGROUND 
 
A suture mark (also known as stitch mark or track mark) is scar tissue thought to be caused by local 
tissue necrosis following suture placement.  The risk of suture marks appears to be associated with 
the timing of suture removal.  Sutures left in situ for longer than seven days increase the risk of 
permanent scarring.   
Percutaneous sutures are commonly used in dermatological surgery to achieve wound edge 
apposition, eversion and to prevent a depressed scar.  Despite the risk of suture marks they are 
often left in situ for longer than seven days especially on sites of skin tension.  On the chest or back 
it is common practice to wait up until 14 days before suture removal.  The timing of suture removal 
is guided by surgeon preference and concern about wound dehiscence.  However, wound 
dehiscence is unlikely to occur where there is adequate placement of dermal or subcuticular sutures 
(sutures beneath the top layer of skin, otherwise known as buried sutures).  Where there is 
adequate subcuticular suturing to close the wound the percutaneous sutures may be removed 
earlier. There is currently no clear consensus on the timing of suture removal and the current 
standard of care varies between 7 and 14 days. 
We hypothesize that earlier removal of percutaneous sutures (7 days rather than 10 days) reduces 
the incidence of suture marks in patients undergoing excision and primary wound closure for 
treatment of skin cancer.  We are also interested to study whether early suture removal has an 
impact upon overall scar cosmesis, patient reported outcome measure, and wound complications 
including bleeding, infection, and dehiscence.   
11. 
RATIONALE & LITERATURE REVIEW 
 
Medline and CENTRAL were searched using the following terms “scar” and “skin” and (“suture” or 
“stitch”).  1585 titles were reviewed.  60 articles were identified for potential relevance and abstracts 
reviewed. 12 full text articles were reviewed. 
 
Suture marks, sometimes described as ‘track marks’, ‘railroad tracks’, ‘cross hatching’ or ‘fishbone 
scars’ are a known complication of suture placement.  The incidence of this occurrence and the 
impact on the patient is not known although they are seen as an unfavourable scar characteristic [1].  
Surgical technique (tissue handling, suture technique, layered closure, use of lines of natural skin 
tension, close approximation and eversion) and patient factors (keloid tendency, skin type or body 
site) are thought to play an important role [2]. Another factor that is thought to play an important 
role is the timing of suture removal.  Sutures left in place for more than seven days are thought to 
increase the risk of suture marks [3].   
 
Percutaneous sutures are generally left in place for longer due to concern about wound dehiscence.  
However, several alternative wound closure techniques have been described to negate the use of 
percutaneous sutures or to reduce suture marks [4]. These studies demonstrate that adequate 
subcuticular suturing is sufficient for prevention of wound dehiscence.  These include the use of 
adhesive glue following dermal closure with buried sutures [5], the use of buried subcuticular sutures 
alone [6], and suture removal and replacement of sutures at 3 days post operatively [7].  Another 

 
 
 
 
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study that assessed the use of adhesive strips following subcuticular running vertical mattress 
sutures found that adhesive strips provided no additional benefit to subcuticular sutures alone [8].   
 
Despite alternatives to percutaneous closure, the use of percutaneous sutures is still common 
practice in dermatological surgery in the UK.  This is because percutaneous sutures are considered 
best practice in order to achieve wound edge eversion and help prevent a depressed scar.  There is 
insufficient evidence to guide the length of time until suture removal but common practice dictates 
that on sites of tension percutaneous sutures should remain in situ for longer until removal.  On the 
chest or back suture removal between 7 and 14 days is normally suggested for suture removal.  
  
Adequate approximation of the wound edges with placement of dermal sutures should negate the 
requirement for percutaneous sutures to remain in situ for longer than seven days even in sites of 
tension.   
 
12. 
THEORETICAL FRAMEWORK 
 
We are interested to assess whether earlier suture removal reduces stitch marks in wounds where 
close approximation of wound edges can be achieved with dermal sutures.  In doing so we hope to 
provide evidence that earlier suture removal reduces the risk of suture marks without increasing 
wound complications. 
 
As the incidence of suture marks is currently uncertain and the impact that these have on the patient 
is unknown we intend to perform a feasibility study prior to conducting a randomized controlled 
trial.  This study would give as indication as to the sample size required to power our RCT correctly.  
It will also provide an indication as to the ease of recruitment, patient participation, loss to follow-
up, and complication rate.  Furthermore, it will allow us to evaluate the use of our chosen assessment 
tools.   
 
We have designed a single centre, randomized, blinded, parallel group feasibility study to assess 
viability of a randomized control trial (RCT) to answer this question. 
13. 
RESEARCH QUESTION 
 
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 questions:  
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)? 
 

 
 
 
 
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*Risk of post-operative bleeding, risk of surgical site infection, risk of wound dehiscence (opening up of 
scar) 
14. 
AIMS AND OBJECTIVES 
 
Aim: 
To test the feasibility of conducting a definitive trial looking at outcomes for earlier removal of 
percutaneous sutures (7 days versus 10 days) for patients undergoing wide local excision and primary 
closure for treatment of skin cancers on the chest or back in dermatology. 
Objectives: 
1. To work out the standard deviation of the outcome measure (suture marks versus no suture 
marks) in order to estimate a sample size required for a properly powered RCT.  (The incidence 
of ‘suture marks’ and the impact that these have on patients is currently unknown). 
2. To provide some preliminary data on the incidence of wound complications and overall scar 
cosmesis in each group and ensure that this does not differ from expected: 
a. Overall cosmesis 
b. Risk of post-operative bleeding 
c. Risk of surgical site infection 
d. Risk of wound dehiscence (opening up of scar) 
3. To assess the willingness of participants to be randomized. 
4. To assess the willingness of clinicians to recruit patients. 
5. To assess follow-up rates and adherence. 
6. To assess the characteristics and ease of use of the proposed outcome measures including 
POSAS for scar assessment, a VAS, and patient reported outcome for complications including 
dehiscence and infection.   
7. To gain feedback from patients at their three month follow up appointment on the patient 
pathway including the trial information leaflet and consent process.  
8. To collect data on any additional costs that we may incur that have not been planned for, to 
inform costing for a future trial e.g. additional printing of PIS or consent forms or additional 
clinic booking slots 
9. To use the gathered data to refine the design of the proposed RCT. 
15. 
LAY SUMMARY 
 
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 

 
 
 
 
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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.   
 
In skin surgery, wounds are commonly closed in two layers.  A layer of dissolving stitches is placed 
under the top layer of the skin to bring the wound edges together.  These stitches do not need to be 
removed.  Another layer of stitches is then placed along the top of the wound, often with non-
dissolvable stitches that need to be removed.  If the wound edges can be brought closely together 
with the deeper stitches, then we do not believe that the top stitches need to stay in place for longer 
than seven days, even on sites of tension.  This is because the deeper stitches should prevent the 
wound from opening up.  We believe that stitch removal at 7 days rather than 10 days reduces the 
risk of stitch marks without increasing the risk of the wound opening up.   
We would like to perform a small study to assess how practical it will be to perform a full study to 
look at whether earlier removal of superficial stitches (7 days rather than 10 days) reduces the risk 
of stitch marks. 
We would also like to assess the impact that stitch marks have on patients, the effect of early stitch 
removal on the overall appearance of the scar, and the effect of early stitch removal on the number 
of wound complications. 
We aim to invite patients to join the study who are having a wide local removal of skin on the back 
or chest.  These patients will be randomly assigned to two groups: stitch removal at 7 days and stitch 
removal at 10 days.  The two groups will otherwise be treated the same.  Patients will be reviewed 
again at 3 months to assess their scar and the presence of stitch marks, and to record information 
about any complications they experienced and information about their experience.  This information 
will be used to assess the feasibility of a larger study to answer the question ‘does earlier removal of 
superficial stitches (7 days rather than 10 days) reduce the risk of stitch marks?’ 
 
16. 
STUDY DESIGN 
 
16.1 Study Setting, Population and Patient Identification 
 
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, Heavitree 
Hospital. The initial skin cancer clinic, surgical procedure and follow-up will all be undertaken within 
the department. 
Our patient population is all patients attending the dermatology department for wide local excision 
as part of their skin cancer treatment and primary closure of the subsequent wound. 
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 and given a patient information 
sheet (PIS). They will be offered and consented for a further telephone call to discuss the study 
further. 

 
 
 
 
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Alternatively, when patients are telephoned to inform them of the date of their surgery, they will be 
informed of the study then. If patients are interested in the study, they will be offered a further 
telephone appointment with a member of the research team to discuss the study further, answer 
any questions and gain verbal consent. The PIS can be emailed or posted to the patient at their 
request. All patients will be offered a telephone call between clinic visit and their date of surgery for 
any questions to be answered and verbal consent to be gained. 
16.2 Data Collection Prior to Surgery 
 
On the day of their surgery, patients will be reminded of the trial and written consent will be sought 
by an appropriate member of the research team. Patients will then have their procedure performed 
and the randomization process will occur. 
Data collection prior to procedure will include smoking status, history of immunosuppression, 
diagnosis of diabetes, full drug history (including steroid and anticoagulants use), age, ethnicity and 
history of keloid scarring or hypertrophic scarring. We will specifically ask for history of steroid use 
as this may affect the healing of scars post-surgery. This should all be recorded as standard practice 
and should not add additional workload, however this will be assessed in the feasibility study. 
Data collection after the surgical procedure will include the size of the wound (maximal width and 
length), number of dermal sutures, type of dermal sutures used and number of percutaneous sutures 
used. Again, these should all be recorded as standard practice. 
 
16.3 Surgical Procedure 
 
The surgical procedure will be performed by one of the dermatological surgeons within the 
department. 
 
All patients will have a standard local anaesthetic comprising lidocaine 1 or 2% with adrenaline 
1:200000.   
 
Patients will have their wide local excision with adequate margin as per regional guidance by an 
appropriately trained practitioner. The wound edges may be undermined if necessary or according 
to surgeon preference in order to achieve primary closure (documented accordingly).  
 
The wound edges will be closely approximated with buried subcuticular interrupted vertical mattress 
sutures using 3/0 PDS (synthetic dissolvable mono filament suture) or equivalent.  The number of 
sutures will be recorded.  If the wound edges cannot be closely approximated then the patient will 
be withdrawn from the study. Interrupted percutaneous sutures will then be placed using ethilon 
4/0  (non-absorbable, nylon monofilament suture) or equivalent in order to achieve optimal wound 
edge eversion. 
 
16.4 Randomization and Blinding 
 

 
 
 
 
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Patients will be randomized into two groups following acceptance into the trial. A dermatology nurse, 
independent to the research trial and not involved in data collection or analysis, will use a random 
number generator to prepare 60 sealed envelopes, labelled ‘participant 1’ to ‘participant 60’. These 
sealed envelopes will contain a slip of paper that either says ‘suture removal at 7 days group’ or 
‘suture removal at 10 days group’. During preparation of these envelopes using the random number 
generator, an odd number produced will be ‘suture removal at 7 days group’ and an even number 
will be ‘suture removal at 10 days group’. The nurse who prepares these envelopes will be 
independent of the research trial to avoid any selection bias and maintain concealment. They will 
also have completed a ‘Good Clinical Practice’ (GCP) certificate. The surgeon and members of the 
research team involved in data gathering and analysis will be blinded to allocation. 
After written consent to the trial has been gained, and excision of the lesion performed, the patient 
will leave the theatre room alongside one of our dermatology nurses/HCAs who is independent of 
the research team in order to maintain concealment and prevent selection bias. The patient and 
nurse/HCA will open one of the sealed envelopes, in numbered order, to reveal which arm of the 
trial they have been allocated to. The patient will be requested not to disclose which arm of the trial 
they were in. The theatre nurse or healthcare assistant will then discuss the post-operative wound 
care and timing of suture removal with the patient.  
Patient blinding is not feasible as patients need to know which day to have their sutures removed 
post-surgery. 
Before the patient leaves the department, an appointment will be booked with their GP for suture 
removal at either 7 or 10 days. If their GP does not have the capacity to remove the sutures on the 
given day, an appointment will be booked within the dermatology department on the given day for 
suture removal. 
If the patient cannot attend the appointment for suture removal specifically on day 7 or 10, they will 
be removed from the study. 
The envelope containing the slip of paper with the randomized trial arm will be re-sealed and placed 
in a larger envelope labelled with the participant number. The signed consent form will also be kept 
in this labelled participant envelope, which will be placed in a secure location in line with data 
governance. 
Concealment of the trial arm allocation will be maintained until trial completion. However, the code 
could be broken in the event of a significant adverse event. 
All recorded data will be anonymized prior to statistical analysis by the statistician.  
 
16.5 Wound Dressing and Post-operative Care 
 
Following wound closure, the wounds will be dressed with steristrips, a sterile film and pad dressing 
as per protocol after skin surgery. After 48 hours, the patients will be instructed to remove the 
dressing and then gently cleanse the wound and apply petroleum jelly to it twice daily until suture 
removal.  This advice will be given to all patients independent on which trial arm they have been 
allocated. 
 

 
 
 
 
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On the day of suture removal, either at GP or in the dermatology department, sutures will be 
removed as per our standard operating procedure (SOP), available in the department or emailed to 
the GP practice performing the suture removal (please see appendices).  
 
If there are any signs of wound dehiscence, or that the wound may dehisce on suture removal, the 
suture may be kept in, as per advice on our SOP. These patients will be withdrawn from the study. 
 
16.6 Data Collection at 3 Month Follow Up 
 
Patients will be booked in for a 3 month follow-up appointment, as per their standard care pathway. 
Data collection at 3 month follow up will include completing a patient and observer scar assessment 
scale (POSAS) with regards to overall scar cosmesis, and also a visual analogue scale (VAS) in relation 
to suture marks specifically. We have chosen these tools as they are validated, well known scales to 
characterise scars subjectively and objectively [10].  
 
The patient will be asked about any post-operative complications that were not detected at suture 
removal including wound infection, dehiscence, and significant post-operative bleeding (defined as 
bleeding requiring assessment by a healthcare professional). Assessment will be carried out by a 
member of the research team who will be blinded to trial allocation.   
 
Photographs of the scar will be taken at the follow-up visit using the departmental camera to allow 
review of scar assessment at a later date if required. This will be directly uploaded onto their 
electronic patient record in line with Trust policy. Patients will be verbally consented for this at time 
of follow up, as per usual practice. 
 
 
17. 
DATA ANALYSIS METHODS 
 
Dr Roy Powell, Statistical advisor, Royal Devon and Exeter hospital has been consulted.   
 
Data collection and input will be carried out by the research team who will be employed by the 
RDEFT and will comply with local and national information governance standards. A password-
protected Excel spreadsheet will be set up on a Trust computer in the Dermatology Department - 
also password protected. All paper and electronic data will be collected and stored in compliance 
with data protection guidelines, good clinical practice in research guidance and Trust clinical 
governance policy. 
 
A feasibility study will provide an opportunity to assess the data to be collected and the choice of 
appropriate statistical tests for a future definitive trial. Data analysis will involve statistical methods 
appropriate to the data collected. The statistical analysis for the feasibility study will be descriptive 
for each group as hypothesis testing is not an aim of the feasibility study and it is likely to be 
underpowered for that anyway. Descriptive statistics of baseline characteristics will be compared 
between study groups to demonstrate the effectiveness of randomisation. Continuous outcome 

 
 
 
 
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data will be tested for normality using the Shapiro Wilks test. If the data are found to be normally 
distributed, central tendency will be expressed using means and dispersion using standard deviation. 
If the data prove not to be Gaussian, and cannot easily be transformed, they will be summarized 
using medians, interquartile ranges and ranges. Mean (or median) differences and the standard 
deviation of the differences will be used to inform sample size calculations for a definitive trial. 
Confidence intervals will be derived wherever possible. Categorical data will be summarized as 
proportions and percentages as appropriate with associated confidence intervals. No attempt will be 
made at this stage to make formal comparisons of outcome measures – this will be done in the 
eventual definitive study. Summaries of secondary outcome measures will also be produced in a 
similar manner to the above. 
 
All data management will adhere to GDPR compliance. Statisticians will be blinded to allocation 
arms. 
 
18. 
SAMPLE AND RECRUITMENT 
 
18.1 Study Population, Sampling and Recruitment 
 
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 and given copies of the PIS. 
They will also be offered a telephone appointment with a member of the research team for further 
information about the trial. 
Alternatively, patients will be informed of the study when telephoned to confirm the time and date 
for their surgery. If they express interest in the study, they will be offered a further telephone call 
with a member of the research team to answer any questions they may have about the study and 
gain verbal consent. The PIS can be emailed or posted to the patient at their request.  
All patients will be offered a telephone call between clinic visit and their date of surgery for any 
questions to be answered and verbal consent to be gained. 
 
18.2 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 

 
 
 
 
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• 
Wound could be closed with primary intention healing 
 
18.3 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. 
 
18.4 Sample Size 
 
As this is a feasibility study, it will not be powered to find significant differences between the groups.  
Instead it is an opportunity to test the feasibility of collecting the specified outcome data and 
describing it in terms of central tendency (mean, median) and dispersion (standard deviation or 
interquartile range as appropriate).  A feasibility study provides an excellent opportunity to uncover 
problems ahead of time, minimizing the need to adapt procedures or to develop contingency plans 
at short notice when the larger study is being conducted. A simple method for choosing a sample 
size for a feasibility study that ensures the discovery of potential problems with high confidence is 
employed here [9]. The method is used to determine the necessary sample size so that a problem is 
likely to be observed at least once during the course of the feasibility study. The emphasis therefore 
is on “problem detection” and not on the estimation of the “problem frequency.” If the probability 
(p) of a problem arising is 0.05, then a sample size of 59 would be required to detect at least one 
instance of the problem. The formula for calculating this is approx. 3/p participants if one wants to 
be approximately 95% certain that the problem will manifest itself at least once during the feasibility 
study. We will aim for 30 analysable cases per group in the final dataset giving a total of 60 cases. 
 
18.5 Sample Identification 
 
As mentioned previously, all patients attending the dermatology department for wide local excision 
as part of their skin cancer treatment will be considered for entry into the trial. Only the members of 
the existing clinical care team will have access to patient records in order to identify potential 
participants during their clinic visit. Any patients that have been informed of the study whilst having 
the time and date of their surgery confirmed, and have expressed interest, will be offered a further 
telephone call to discuss the study in depth and have any questions answered. 
 
18.6 Consent 
 
All patients who express interest in the study will be given the patient information leaflet either in 
physical form, post or email. They will be invited to discuss the project further with a member of the 
research team by means of a telephone call between their clinic attendance and surgical 

 
 
 
 
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appointment. Participants will be given sufficient time to read the information sheet and ask any 
further questions prior to consenting. Verbal consent will be gained on the telephone. 
 
Participants willing to join the trial will have written informed consent obtained by a member of the 
research team at the time of their surgery attendance. A electronic copy of this research consent will 
be placed on the participants electronic hospital record. Only once they are fully informed will they 
be asked to make a decision to enter the trial.  
 
The patient will be informed that they do not have to take part in the study and if they choose not to 
take part, refusal to enter into the study will not compromise their care.   
 
The patient will also be informed that if at any time they wish to withdraw from the study they can 
do so, without having to give a reason and again this will not compromise their care.  
 
The patient’s GP will be informed by letter of the patient’s inclusion in the study. 
 
If any new information becomes available which may be relevant to the patients consent, forms will 
be revised and informed consent sought again.     
 
Once the decision to take part has been agreed, randomization will occur. 
 
Please seen appendix for patient information leaflets and consent documents. 
 
19. 
ETHICAL AND REGULATORY COMPLIANCE 
 
19.1 Patient Safety and Serious Adverse Events 
 
A serious adverse event (SAE) is any untoward medical occurrence that: 
• 
Results in death; 
• 
Is life-threatening; 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization; 
• 
Results in persistent or significant disability/incapacity; 
• 
Consists of a congenital anomaly or birth defect. 
 
Adverse events (AE) that may occur and for which patients will be consented include: 
• 
Bleeding 
• 
Infection 
• 
Scarring 
• 
Wound dehiscence 
• 
Pain 
 
We do not anticipate there being any increase in adverse events in either arm.  The aim of the study 
is to assess whether early suture removal reduces scarring.  It may become apparent that scarring is 

 
 
 
 
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less in the early suture removal arm.  We will record the incidence of adverse events in both 
treatment arms to ensure that patients are not experiencing a greater number of adverse events in 
either treatment group 
This is a pragmatic trial: the nature of the study means that it involves routine clinical practice. There 
should be no additional risk to patients beyond routine care. With good participant information and 
subsequent post-trial engagement, we would hope to recruit rapidly to the trial. 
 
All AE’s and SAE’s will be reported to R&D within 24hrs of the investigator being made aware of the 
event. An SAE occurring to a participant will be reported to the REC that gave a favourable opinion 
of the study where the event was related or unexpected. This will be reported within 15 working 
days. 
 
19.2 Assessment and Management of Risk 
 
The principle investigators have a professional obligation to closely monitor participants and in the 
event of an adverse event being identified, follow established clinical treatment or referral protocols.   
 
19.3 Quality Assurance Procedures 
 
The study will be monitored in accordance with the current approved protocol and good clinical 
practice.  Surgical technique, methodology and outcome will all be monitored and audited in 
accordance with current departmental practice.   
 
19.4 Research Ethics Committee (REC) Review and Reports 
 
Before the start of the study, a favourable opinion will be sought from a REC for the study protocol, 
informed consent forms and other relevant documents. 
 
Substantial amendments that require review by NHS REC will not be implemented until that review 
is in place and other mechanisms are in place to implement at site. All correspondence will REC will 
be retained. 
 
It is the Chief Investigator’s responsibility to produce the annual reports as required and they will 
notify the REC at the end of the study. An annual progress report will be submitted to the REC within 
30 days of the anniversary date on which the favourable opinion was given, if the study has not been 
declared ended by then. 
 
If the study is ended prematurely, the Chief Investigator will notify the REC including the reasons for 
the premature termination. 
 
Within one year after the end of the study, the Chief Investigator will submit a final report with the 
results, including any publications/abstracts, to the REC. 

 
 
 
 
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19.5 Amendments 
 
If any substantial amendments to the protocol or supported documents is required, a notice of 
amendment will be submitted to the REC.  
 
19.6 Protocol Compliance 
 
Any deviations from the planned protocol will be documented and reported to the Chief Investigator 
and Sponsor immediately. 
 
19.7 Data Protection and Confidentiality  
 
The patients will be recruited to the trial and all data will be stored anonymously against a 
participant number. Only the clinical team will have access to the single table correlating patient 
name and participant number. This information will not be shared. All clinical and routine data will 
be collected and placed in a database by the clinical team preserving anonymity throughout the trial. 
It has been considered that the feasibility trial may begin to demonstrate clear advantages of one 
technique over the other. However, with the patient numbers involved, it seems unlikely that 
differences in the technique will be observed at levels that are statistically significant. 
 
Data will be stored for 5 years then destroyed appropriately. 
 
All paper and electronic data will be collected and stored in compliance with data protection 
guidelines, good clinical practice in research guidance and Trust clinical governance policy. 
 
Please see ‘Data Analysis Methods’ for further information. 
 
19.8 Access to the Final Study Dataset 
 
The final data set will be able to be accessed by the Chief Investigator and Principle Investigators. 
 
20. 
DISSEMINATION POLICY 
 
On completion of the study, the data will be analysed and tabulated and a final study report will be 
prepared and issued to the Chief Investigator and Principle Investigator. Based on the results of this 
feasibility study, we may be in the position to write a grant proposal in order to conduct a definitive 
RCT in the future. 
 
20.1 Authorship  
 
Those who participated in study design, execution and analysis will be granted authorship 

 
 
 
 
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21. 
REFERENCES 
 
[1] Weitemeyer MB, Bramsen P, Klausen TW, Hölmich 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.  
[2] Prowse P. , Shokrollahi K. Leaving our mark – are suture marks acceptable? Sept 2014, V96 (8) pp. 
264-266  
[3] Crikelair G. Skin suture marks. Am J Surg 1958: 96; 631–639 
[4] Moy RL, Waldman B, Hein DW. A review of sutures and suturing techniques. J Dermatol Surg 
Oncol 1992; 18: 785–795 
[5] Hasan Z , et al. Sutureless skin closure with isoamyl 2-cyanoacrylate in pediatric day-care surgery. 
Pediatr Surg Int 2009; 25: 1,123–1,125. Crossref, Google Scholar  
[6] Hohenleutner , et al. Intradermal buried vertical mattress suture as sole skin closure: Evaluation 
of 149 cases. Acta Derm Venereol 2000; 80: 344–347. Crossref, Google Scholar  
[7] Wolf R. Serial replacement of sutures for preventing suture marks. J Dermatol Surg Oncol 1993: 
19: 1131 
[8] 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.  
[9] Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J and Crutzen R. (2015) A simple formula 
for the calculation of sample size in pilot studies. Journal of Clinical Epidemiology, 68 (11) 1375-79. 
[10] Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. 
Eplasty. 2010;10:e43. Published 2010 Jun 21 
22. 
APPENDICIES 
 
22.1 Appendix 1 - Required Documentation  
 
• 
CV’s of research team 
• 
Patient information sheet 
• 
Patient informed consent form 
• 
Data collection form 
• 
POSAS Observer Scale 
• 
POSAS Patient Scale 

 
 
 
 
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• 
VAS scale 
• 
Standard Operating Procedure (SOP) for suture removal 
 
 
22.2 Appendix 2 - Amendment History  
 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
v1 
June 2021 
Ellen Richards 
Protocol for submission 
V2 
19th Sep 2021 
Ellen Richards 
Protocol updated with REC comments 
 
22.3 Appendix 3 – CV of Chief Investigator (Dr Emily McGrath) 
22.4 Appendix 4 – CV of Co-Principle Investigator (Dr Ellen Richards) 
22.5 Appendix 5 – CV of Co-Principle Investigator (Dr Alistair Brown) 
 
 
 
 
22.6 Appendix 6 – Patient Information Sheet 
 

 
 
 
 
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Timing of Suture Removal to 
Reduce Scarring in Skin 
Surgery 
 
 
 
 
 
Patient Information Sheet 
v3, 19th September 2021 

 
 
 
 
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Timing of Suture Removal to Reduce Scarring 
                           in Skin Surgery 
 
We are inviting you to take part in a research study called ‘Timing of Suture 
Removal to Reduce Scarring in Skin Surgery’ 
 
• 
Please take time to read the following information carefully. Discuss it with friends and relatives 
if you wish. Take time to decide whether or not you wish to take part. 
• 
You are free to decide whether or not to take part in this research study. If you choose not to 
take part, this will not affect the care you get from your own doctors in any way. 
• 
You can stop taking part in the study at any time, without giving a reason. 
• 
Ask us if there is anything that is not clear or if you would like more information.  
• 
Thank you for reading this information. If you decide to take part you will be given a copy of this 
information sheet and asked to sign a consent form. You’ll get a copy of that as well.  
 
Important things that you need to know 
 
• 
Suture marks are permanent marks left in the skin where suture placement has caused local 
tissue damage and scarring.  
• 
We want to find out whether earlier suture removal prevents suture marks without affecting 
wound healing on the chest and back.  
• 
We are testing suture removal at 7 days vs 10 days in patients undergoing excision and repair of 
suspected skin cancers on the chest and back. 
• 
The study will fit into your normal treatment if you require follow-up following your surgery, so 
that no extra hospital visits are required.  However, if no routine follow-up is required the study 
will require you to visit the hospital once more than if you were being treated in the usual way. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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Contents 
 
 
 
 
 
 
 
 
 
Page 
 
1 
Why are we doing this study?  
 
 
 
 
 
4 
2 
Why am I being asked to take part?  
 
 
 
 
 
5 
3 
What do I need to know about the intervention proposed? 
 
 
5 
4 
What will I need to do if I take part? 
 
 
 
 
 
5 
5 
What are the possible benefits of taking part?   
 
 
 
6 
6 
What are the possible disadvantages and risks of taking part?  
 
6 
7 
More information about taking part 
 
 
 
 
 
7 
8 
Contacts for further information  
 
 
 
 
 
8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sponsor: Royal Devon and Exeter NHS Trust 
 
How to contact us 
If you have any questions about this study, please talk to your dermatology doctor or nurse. The 
Chief Investigator (CI) and Principle Investigators (PI) can be contacted via the below details: 
 
Dr Emily McGrath (CI), Dr Ellen Richards (PI), Dr Alistair Brown (PI) 
Dermatology Department 
Heavitree Hospital  
Royal Devon and Exeter NHS Foundation Trust 
EX1 2ED 
01392 405512 

 
 
 
 
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1 
Why are we doing this 
study?  
 
What are suture marks? 
 
Suture marks, otherwise known as stitch marks or track marks, are permanent marks left in the skin 
where suture placement has caused local tissue damage and scarring. 
 
How common are suture marks? 
 
At the moment we do not know the answer to this question but they occur more commonly on sites 
of skin tension such as the chest and back. 
 
Why do suture marks develop? 
 
The risk of developing suture marks is probably affected by a number of factors including surgical 
technique and the patient’s own skin and health. Some sites on the body (such as the chest and 
shoulders) are more prone to scarring.  The risk of these marks is also thought to be in part related 
to the duration of time that the sutures are left in place before removal.   
 
How long are sutures normally left in place? 
 
When a wound is closed in dermatology a layer of dissolving sutures is placed under the top layer of 
skin to bring the wound edges together.  These sutures do not need to be removed.  Another layer 
of sutures is placed along the top of the wound.  These sutures are normally removed between 7 
and 14 days post-surgery.  Sutures may be left in place for longer if there is a concern about the 
wound opening up.  This is more common on sites of tension such as the chest and back.   
 
Why is a study needed? 
 
There are several questions that we want to answer: 
 
1. At the moment, we do not have good evidence that removing sutures early will prevent suture 
marks or have an effect on the appearance of the scar. We hope to demonstrate that early suture 
removal reduces scarring. 
 
2. We hope to estimate how commonly suture marks occur. 
 
3. We also do not know whether removing the sutures early will have any other consequences such 
as opening up of the wound. 
 
4. Finally, we hope to assess the impact that suture marks have on patients 
 
 

 
 
 
 
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2 
Why am I being asked to 
take part?  
 
You are being asked to take part in the study because you are planned to have an excision of a 
suspected skin cancer from your chest or back in the dermatology department.  We anticipate that 
the wound will be closed directly without involving any complex repair or skin graft.   
 
3 
What do I need to know 
about the intervention 
proposed?  
 
Your surgery will be performed in the same way regardless of whether you choose to be involved in 
the trial or not and will be performed in accordance with departmental practice.  
 
After the surgery you will be allocated to have your sutures removed at either 7 days or 10 days post 
operatively.   
 
4 
What will I need to do if 
I take part?  
 
Can I definitely take part? 
 
Not everyone may be able to take part in this study. We need to check your eligibility first to see 
whether you are suitable to take part.  If we are unable to close your wound adequately using the 
buried dissolving sutures you will be excluded from the trial. 
 
What if I am eligible to take part? 
 
If you are eligible and you agree to join the study, we will ask you to sign a consent form.  
There will be two different procedure groups in this study. These are: suture removal at 7 days and 
suture removal at 10 days. 
 
Which group will I be in?   
 
It is important that the groups receiving suture removal at 7 and at 10 days are as similar as possible 
at the start of the study. To ensure that this happens, randomisation is used to allocate people to 
each group.  You will find out which group you are in immediately following your surgical procedure.  
 
What will happen to me during the study?  
 

 
 
 
 
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You will be identified by a clinician or member of the research team prior to your skin surgery. You 
will be provided with a patient information sheet (PIS) either in person, or emailed/posted. All 
patients identified will be offered a telephone appointment to further discuss the project and gain 
verbal consent.  
 
If you have consented to take part in the study your surgery will then be carried out as per 
departmental practice.  This will not differ whether you are involved in the trial or not.  Immediately 
after your surgery your trial allocation will be revealed and the timing of your suture removal will be 
discussed with you.  This will either be at 7 days or 10 days. We will book an appointment with your 
GP for you in order to ensure your sutures are removed on the correct day. If your GP does not have 
capacity to perform suture removal on the specific day, you will be booked for suture removal in the 
dermatology department. If you cannot attend for suture removal on the specific day you have been 
randomised to, you will be withdrawn from the study. This will not affect your ongoing care. 
 
We would ask that if you do take part in this study, to not discuss the timing of your suture removal 
with the research team. 
 
On the day of your suture removal, either at GP or in the dermatology department, sutures will be 
removed as per our standard operating procedure (SOP) for suture removal. If there are any signs of 
wound dehiscence (your wound coming apart), or that the wound may dehisce on suture removal, 
the sutures may be kept in for an additional amount of time, as per advice on our SOP. If this is the 
case, you will be withdrawn from the study. This will not affect your ongoing care. 
 
You will then be reviewed at 3 months post operatively for a review of your scar and completion of a 
questionnaire about your subjective and objective opinion of your scar. We will ask you to rate on a 
scale of 1 to 10 about your opinion on the overall colour, thickness and appearance of your scar, 
using a validated tool called the ‘patient and observer scar assessment scale’ (POSAS). We will also 
ask for your opinion on the appearance of suture marks specifically using a ‘visual analogue scale’ 
(VAS). A healthcare professional will also assess the appearance of your scar and suture marks and 
take photographs that will be uploaded directly to your patient record. Again, we would kindly ask 
you to not discuss timing of suture removal with the research team at this point. 
 
 If you are being followed up routinely for your skin cancer we will arrange this in the same visit.  
 

 
 
 
 
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Will I get back any travel costs? 
 
Travel costs for the follow-up clinic visit will not be re-imbursed. 
 
5 
What are the possible 
benefits of taking part in 
this study?  
 
The information we get from this study will help us to improve treatment for present and future 
patients undergoing skin surgery.  
 
We are aiming to gather data to determine whether a large scale trial can be performed to answer 
the question of whether early suture removal may reduce scarring in skin surgery. By participating in 
this study, you will be helping us to gather data required to perform a larger scale trial which may 
affect medical practice in the future. 
 
A decision will be made at 
your dermatology clinic that 
you will requrie skin surgery
You will be informed of the 
study and given a patient 
information sheet to take 
home and read
You will be called to inform 
you of the date of your 
surgery. You will be invited 
to take part then and offered 
a further telephone 
appointment about the study
You will be offered a  
telephone call before your 
surgery to discuss the study 
and have the opportunity to 
ask any questions
On the day of your surgery, 
we will confirm you are 
happy to be included and ask 
you to sign a consent form
Once your surgery is 
complete, you will leave the 
room with a healthcare 
professional and find out 
when your sutures are to be 
removed
We will book an appointment 
wiht your GP or in the 
dermatology department to 
have your sutures removed
Attend your appointment 
at day 7 or 10 for suture 
removal
Follow-up at 3 months with a 
clinic appointment for wound 
review
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6 
What are the possible 
disadvantages and risks 
of taking part?  
 
All surgical procedures have some associated risks. The most common adverse effects of skin surgery 
are:  
• 
Risk of bleeding post operatively 
• 
Risk of surgical site infection (2-5%) 
• 
It may be painful when the local anaesthetic is inserted and when this wears off 
• 
You will be left with a permanent scar which may fade over time 
• 
Wound dehiscence (opening up of the wound) due to stretching of the scar or failure of the 
sutures 
It may be possible that early suture removal may increase your risk of wound dehiscence. However, 
if at day 7 or 10 your healthcare professional has concerns that removing sutures on the day will 
cause wound dehiscence or complications, your sutures will not be removed and you will be 
excluded from the study. Your healthcare professional will be able to give you additional advice in 
this instance. 
If you become concerned about any side effects, please tell the study staff as soon as possible.  
We do not anticipate there being any increased risks in either group but it may become apparent 
that one procedure reduces the risk of scarring or wound dehiscence more than the other following 
the study. 
 
7 
More information about 
taking part 
 
Do I have to take part in the “Timing of Suture Removal to Reduce Scarring in Skin Surgery” study? 
 
No, it is up to you to decide whether or not to take part. If you decide to take part you will be given 
this information sheet to keep and you will be asked to sign a consent form. Your GP will also be 
informed of your participation in this study. 
 
If you decide not to take part in this study, you are likely to receive the standard treatment, which is 
removal of sutures between 7 and 14 days at the discretion of the operating surgeon.  A decision to 
not take part at any time will not affect the standard of care you receive. 
 
Can I stop taking part after I’ve joined the study?  
 
You can stop taking part in all of this study, or in any part of it, at any time and without giving a 
reason. However, you must talk to your study doctor or nurse first so that they can advise you about 

 
 
 
 
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any concerns you may have. A decision to stop taking part at any time will not affect the standard of 
care you receive. 
 
How will we use information about you?  
 
We will need to use information from you and the follow up from your procedure for this research 
project. This information will include your name, NHS number, contact details and procedure details. 
People will use this information to do the research or to check your records to make sure that the 
research is being done properly. 
People who do not need to know who you are will not be able to see your name or contact details. 
Your data will have a code number instead.  
We will keep all information about you safe and secure.  
Once we have finished the study, we will keep some of the data so we can check the results. We will 
write our reports in a way that no-one can work out that you took part in the study. 
What are your choices about how your information is used? 
You can stop being part of the study at any time, without giving a reason, but we will keep 
information about you that we already have.  
We need to manage your records in specific ways for the research to be reliable. This means that we 
won’t be able to let you see or change the data we hold about you.  
Where can you find out more about how your information is used? 
 
You can find out more about how we use your information  
• 
at www.hra.nhs.uk/information-about-patients/ 
• 
by asking one of the research team 
• 
by sending an email or by ringing us on the contact details supplied on page 3 of this 
patient information sheet 
 
What will happen to the results of this study? 
 
When the study is completed, we will publish a summary of the results on our website.  
We will also publish the results in a medical journal, so that other doctors can see them. 
You can ask your doctor for a copy of any publication. Your identity and any personal details will be 
kept confidential. No named information about you will be published in any report of this study.  
 
Data will be stored for 5 years then destroyed appropriately. 
 

 
 
 
 
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Who is organising and funding the study?  
 
This study is organised by the Dermatology department at the Royal Devon and Exeter NHS 
Foundation Trust. 
 
Your doctor is not receiving any money or other payment for asking you to be part of the study.  
The Royal Devon and Exeter NHS Foundation Trust has overall responsibility for the conduct of the 
study. It is responsible for ensuring the study is carried out ethically and in the best interests of the 
study participants. 
 
Who has reviewed the Timing of suture removal to prevent suture marks in skin surgery study? 
 
It has been authorised by the Essex Research Ethics Committee (REC) and the hospital’s Research 
and Development Office.  
 
What if new information becomes available during the course of the study? 
 
Sometimes during a study, new information becomes available about the procedures that are being 
studied. If this happens, your doctor will tell you about it and discuss with you whether you want to 
continue the study. If you decide to stop taking part, your doctor will arrange for your care to 
continue outside of the study. 
 
Your doctor might also suggest that it is in your best interests to stop taking part in the study. Your 
doctor will explain the reasons and arrange for your care to continue outside the study.  
 
What happens if the Timing of Suture Removal to Reduce Scarring in Skin Surgery study stops 
early? 
 
Very occasionally a study is stopped early. If it happens, the reasons will be explained to you and 
your doctor will arrange for your care to continue outside of the study. 
 
What if something goes wrong for me? 
 
If you have any concerns about the way you have been approached or treated during the study, 
please talk to your study doctor or nurse. If you are still unhappy, or if you wish to complain, please 
use the normal NHS complaints process.  Our local Patient Advice and Liaison Service will be able to 
advise you further and they can be contacted by phone (01392 402093) or email (rde-
tr.PALS@nhs.net). 
 
In the event that something does go wrong and you are harmed during the research and this is due 
to someone's negligence then you may have grounds for a legal action for compensation against 
Royal Devon and Exeter NHS Trust but you may have to pay your legal costs. The normal National 
Health Service complaints mechanisms will still be available to you (if appropriate). 

 
 
 
 
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8 
Contacts for further 
information 
 
If you want further information about the Timing of Suture Removal to Reduce Scarring in Skin 
Surgery study, please contact your dermatology doctor or nurse, otherwise see page 3 for contact 
information for Chief Investigator and Principle Investigators. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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22.7 Appendix 7 – Patient Informed Consent Form 
Participant Consent Form 
IRAS ID: 303519 
Participant Number: 
 
 
 
 
 
 
 
 
         Initials: 
 
I confirm that I have read the patient information sheet, v3, dated 9th September 2021 for the 
above study. I have had the opportunity to consider the information, ask questions and have had 
these answered satisfactorily. 
 
 
I understand that my participation is voluntary and that I am free to withdraw at any time without 
giving any reason, without my medical care or legal rights being affected. 
 
 
 
I agree to my General Practitioner being informed of my participation in the study. 
 
 
 
I agree to having photos taken of my skin lesion, which will be uploaded directly to my electronic 
patient record  
 
 
 
I agree to my medical records being accessed by the research team for routinely collected data 
such as age, past medical history and surgical procedure notes 
 
 
 
I agree to take part in the above study. 
 
 
 
 
Participant: 
 
Signature:  
 
...................................................................................................... 
 
Date: ....../....../...... 
Name (please print): 
 
...................................................................................................... 
 
 
 
 
 
 
Consenter: 
 
Signature:  
 
...................................................................................................... 
 
Date: ....../....../...... 
Name: (please print): 
 
 
 

 
 
 
 
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...................................................................................................... 
 
22.8 Appendix 8 – Data Collection Form 
Data Collection Form 
Participant Number: 
 
 
 
Data Collection at Time of Surgery 
 
Age: 
 
 
Ethnicity: 
 
 
Clinical diagnosis (pre-op): 
 
 
Site: 
 
 
Length of wound (mm): 
 
 
Width of wound (mm): 
 
 
Number and type of 
interrupted subcuticular 
sutures: 
 
Number and type of 
interrupted percutaneous 
sutures: 
 
Drug history 
(immunosuppressants or 
anticoagulants): 
 
Diabetic diagnosis: 
 
 
Smoking history: 
 
 
History of keloid scar or 
hypertrophic scarring: 
 
Normal length of time 
recommended for suture 
removal in this case: 
 
 
 
 
 
 

 
 
 
 
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Data Collection at 3 Month Follow-up 
 
Stitch marks visible 
(yes/no): 
 
 
POSAS: 
 
 
 
Patient 
scale 
Pain: 
 
Itch: 
 
Colour: 
 
Stiffness: 
 
Thickness: 
 
Irregular: 
 
Overall Opinion (not part of total score): 
 
Total: 
 
 
 
 
Observer 
Scale 
Vascularity (pale; pink; red; purple; mix): 
 
Pigmentation (hypo; hyper; mix): 
 
Thickness (thicker; thinner): 
 
Relief (more; less; mix): 
 
Pliability (Supple; stiff; mix): 
 
Surface area (expansion; contraction; mix): 
 
Overall Opinion (not part of total score): 
 
Total: 
 
VAS: 
 
 
Wound infection (defined 
using CDC criteria for 
surgical site infection)*: 
 
 
Wound dehiscence: 
 
 
Significant post-operative 
bleeding: 
 
 
Any other comments:  
 
 
 
* Infection occurs within 30 days after the operation and infection involves only skin and subcutaneous 
tissue of the incision and at least one of the following: 
1.Purulent drainage with or without laboratory confirmation, from the superficial incision 
2.Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision 

 
 
 
 
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3.At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, 
redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-
negative 
4.Diagnosis of superficial incisional SSI made by a surgeon or attending physician 

 
 
 
 
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22.9 Appendix 9 – POSAS Observer Scale 
 

 
 
 
 
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22.10 Appendix 10 – POSAS Patient Scale 
 
 
 

 
 
 
 
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22.11 Appendix 11 – Numerical Visual Analogue Scale (VAS) 
 
Numerical Visual Analogue Scale (VAS) 
 
Participant Number: 
 
Please make a mark on the line below where you feel the appearance of your scar lies, with 
regards to suture marks. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Poor 
appearance 
of suture 
marks 
Excellent 
appearance 
of suture 
marks 

 
 
 
 
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22.12 Appendix 12 – GP letter 
 
Dermatology Department 
Heavitree Hospital 
Gladstone Rd  
Exeter 
EX1 2ED 
Ellen.richards6@nhs.net 
 
 
INSERT DATE 
 
Dear INSERT NAME OF GP 
 
TIMING OF SUTURE REMOVAL TO REDUCE SCARRING IN SKIN SURGERY 
 
Re: PARTICIPANT DETAILS 
 
The above named person has kindly agreed to take part in this research study. The objective 
of the study is to determine whether suture removal at day 7 or day 10 post skin surgery will 
affect suture marks and overall cosmesis of scars. 
 
Your patient has been chosen to take part because they have been booked for a wide local 
excision for their skin cancer surgery. 
 
Should you have any queries about this, please do not hesitate to contact me on the details 
above. 
 
Yours Sincerely, 
 
Dr Ellen Richards 
Academic Foundation Doctor 
Royal Devon and Exeter Hospital NHS Trust 
 
 
 
 
 
 
 
 
 

 
 
 
 
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22.13 Appendix 13 – Standard Operating Procedure (SOP) for Suture Removal 
Standard Operating Procedure (SOP) for 
Suture Removal 
Aim: 
The nurse or healthcare assistant is able to assess the wound post operatively, remove the 
superficial sutures appropriately and recommend simple post-operative wound care 
 
Procedure: 
 
1. Confirm the patients identity and gain consent for removal of sutures 
2. Wash hands and prepare procedure trolley surface aseptically with correct 
equipment: 
a. Disposable Fine tipped non toothed forceps 
b. Dressing pack – containing sterile gloves and gauze 
c. Disposable sharp surgical scissors 
d. Sterile normal saline if required 
3. Wash hands and use non-sterile gloves to remove current dressing (if any) 
4. The wound should specifically be checked for signs of dehiscence, infection or poor 
wound healing. If this is the case, medical advice should be sought 
5. If the wound shows signs that it may dehisce if sutures are removed at the time, then 
consider keeping sutures in for removal at a later date at the discretion of the 
healthcare professional. These patients will be excluded from the study. If this is the 
case, it is important that you let the study team know by contacting us on the below 
details. 
6. Removal of simple percutaneous interrupted sutures: 
a. Wash hands and don sterile gloves 
b. Gently grasp the knot of a suture with forceps and raise it slightly 
c. Place the tip of the suture scissors directly under the knot or on the side close 
to the skin 
d. Gently cut the suture and pull it out gently across the wound with the forceps  
i. Remove the suture across the wound to minimise any exposed suture 
passing through the skin and wound during the removal, this can lead 
to infection. Cutting the correct part of the suture (part directly under 
the knot on the side closest to the skin), will bypass this from happening 
e. Place steri-strips on the sites that sutures have been removed. These are 
applied in opposite directions with a small amount of tension to take tension 
away from the wound. Educate patient to let the steri-strips fall off naturally 
(usually 1-2 days). No further treatment to the wound should be required. 

 
 
 
 
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f. Continue to remove sutures until all sutures have been removed  
g. The application of a suitable wound dressing can be applied at the healthcare 
professionals discretion 
h. Discard sutures as per local policy and record the intervention in the medical 
notes 
i. Dispose any sharps and used instruments safely according to trust policy 
 
If there have been any early post-operative complications, such as dehiscence, infection or 
poor wound healing, please could you contact the study organisers on the details below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dr Emily McGrath (CI), Dr Ellen Richards (PI), Dr Alistair Brown (PI) 
Dermatology Department 
Heavitree Hospital  
Royal Devon and Exeter NHS Foundation Trust 
EX1 2ED 
01392 405512 
ellen.richards6@nhs.net 
Removal 
direction across 
the wound