Suture Related Complication
Conditions
Brief summary
This is a single centre prospective randomized assessor blinded parallel group feasibility study that will be undertaken in the Royal Devon and Exeter Dermatology department. The investigators will be looking at whether timing of percutaneous suture removal after skin surgery impacts on the incidence of suture marks and overall scar cosmesis.
Detailed description
Stitch marks (also known as suture marks or track marks) are permanent marks left in the skin where the stitch has caused local tissue damage and scarring. The risk of these marks is in part thought to be related to the length of time that the stitches are left in place before removal. Stitches are normally left in place for longer on sites where the skin is under greater tension such as the chest or back because there is a concern that the wound may be more likely to open up on these sites. On the chest or back, stitches may be left in place for up to 14 days even though the chest or back is a common site for stitch marks to form. The investigators are conducting a single centre prospective randomized assessor blinded parallel group feasibility study to estimate a sample size required for a properly powered RCT, and also to provide some preliminary data on the incidence of wound complications and overall scar cosmesis in each group. All patients attending the dermatology department for wide local excision as part of their skin cancer treatment and primary closure of the subsequent wound will be considered for entry into the trial. Clinicians will identify potential participants during routine practice at their clinic visit. Patients who fulfil the entry criteria will be invited at that appointment to take part. On the date of participants skin surgery, they will be consented and randomized to either 'suture removal at 7 days' or 'suture removal at 10 days'. Participants will then be booked for a 3 month follow up where the scar site will be evaluated from a patient and clinician perspective to assess suture marks and overall cosmesis.
Interventions
OTHERTiming of suture removal
Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
Sponsors
Royal Devon and Exeter NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Intervention model description
Single centre prospective randomized assessor blinded parallel group feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients of 18 years old or above who had capacity to consent to surgery who were willing to attend follow-up appointments within the department * Patients undergoing wide local excision as part of their skin cancer treatment pathway * Lesions excised from the anterior chest or back * Post-operative wound \>/= 10mm width * Wound could be closed with primary intention healing
Exclusion criteria
* Inability to provide valid informed consent and/or unwilling to attend for follow-up * Wounds where the edges could not be closely adhered with dermal sutures alone. * Wounds requiring a flap or graft for closure. * Patients requiring further treatment following original excision eg. Further WLE, radiotherapy etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Does Earlier Suture Removal Have an Impact (Negative or Positive) on Overall Scar Cosmesis and Wound Complication Rates (as Assessed by the Clinician and the Patient)? | 3 months | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suture Removal at 7 Days Suture removal at 7 days post skin surgery
Timing of suture removal: Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery | 21 |
| Suture Removal at 10 Days Suture removal at 10 days post skin surgery
Timing of suture removal: Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery | 18 |
| Total | 39 |
Baseline characteristics
| Characteristic | Suture Removal at 7 Days | Suture Removal at 10 Days | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 7 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 20 Participants |
| Age, Continuous | 66 years | 61 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 18 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 18 |
| other Total, other adverse events | 0 / 21 | 0 / 18 |
| serious Total, serious adverse events | 0 / 21 | 0 / 18 |
Outcome results
Primary
The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups
In patients undergoing wide local excision and primary wound closure for treatment of skin cancer does earlier removal of percutaneous sutures (7 days rather than 10 days) reduce the incidence of suture marks assessed at 3 months post-operatively. The patient and observer scar assessment scale (POSAS) was used. The patient POSAS was comprised of a score between 1-10 each for pain, itch, colour, stiffness, thickness and irregularity. The observer POSAS was comprised of a score between 1-10 each for vascularity, pigmentation, thickness, relief, pliability and surface area. 1 being normal skin and 10 abnormal skin. The total POSAS scores for both patients/observers were calculated by adding these up, with min/max 1-60. Higher scores equating to worse outcomes. A visual analogue scale (VAS) was used (min/max 1 to 10) to assess the appearance of suture marks, with 1 being normal skin and 10 being abnormal.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Suture Removal at 7 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | POSAS Total Score (Observer) | 12.9 score on a scale |
| Suture Removal at 7 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | POSAS Total Score (Participant) | 19.5 score on a scale |
| Suture Removal at 7 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | VAS scores for suture marks (Observer) | 7.2 score on a scale |
| Suture Removal at 7 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | VAS scores for suture marks (Participant) | 8.4 score on a scale |
| Suture Removal at 10 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | VAS scores for suture marks (Participant) | 7.4 score on a scale |
| Suture Removal at 10 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | POSAS Total Score (Observer) | 16.1 score on a scale |
| Suture Removal at 10 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | VAS scores for suture marks (Observer) | 6.6 score on a scale |
| Suture Removal at 10 Days | The Measured Difference in POSAS and VAS Scores Between 7-day and 10-day Groups | POSAS Total Score (Participant) | 20.3 score on a scale |
Secondary
Does Earlier Suture Removal Have an Impact (Negative or Positive) on Overall Scar Cosmesis and Wound Complication Rates (as Assessed by the Clinician and the Patient)?
The impact on overall scar cosmesis was investigated using the POSAS score (results detailed above) and wound complications rates are detailed below for each group.
Time frame: 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Suture Removal at 7 Days | 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)? | Bleeding | 0 participants |
| Suture Removal at 7 Days | 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)? | Infection | 1 participants |
| Suture Removal at 7 Days | 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)? | Dehiscence | 1 participants |
| Suture Removal at 10 Days | 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)? | Bleeding | 0 participants |
| Suture Removal at 10 Days | 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)? | Infection | 2 participants |
| Suture Removal at 10 Days | 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)? | Dehiscence | 1 participants |