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Trial Outcomes & Findings for Timing of Suture Removal to Reduce Scarring in Skin Surgery (NCT NCT05036785)

NCT ID: NCT05036785

Last Updated: 2024-10-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

3 months

Results posted on

2024-10-24

Participant Flow

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
30
30
Overall Study
COMPLETED
21
18
Overall Study
NOT COMPLETED
9
12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Timing of Suture Removal to Reduce Scarring in Skin Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Suture Removal at 7 Days
n=21 Participants
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
Suture Removal at 10 Days
n=18 Participants
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
Total
n=39 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=93 Participants
11 Participants
n=4 Participants
20 Participants
n=27 Participants
Age, Categorical
>=65 years
12 Participants
n=93 Participants
7 Participants
n=4 Participants
19 Participants
n=27 Participants
Age, Continuous
66 years
n=93 Participants
61 years
n=4 Participants
64 years
n=27 Participants
Sex: Female, Male
Female
11 Participants
n=93 Participants
11 Participants
n=4 Participants
22 Participants
n=27 Participants
Sex: Female, Male
Male
10 Participants
n=93 Participants
7 Participants
n=4 Participants
17 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=93 Participants
18 Participants
n=4 Participants
39 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
United Kingdom
21 Participants
n=93 Participants
18 Participants
n=4 Participants
39 Participants
n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Suture Removal at 7 Days
n=21 Participants
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
Suture Removal at 10 Days
n=18 Participants
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
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
Interval 2.0 to 10.0
7.4 score on a scale
Interval 3.0 to 10.0
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
Interval 6.0 to 26.0
16.1 score on a scale
Interval 6.0 to 32.0
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
Interval 6.0 to 44.0
20.3 score on a scale
Interval 6.0 to 49.0
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
Interval 3.0 to 10.0
6.6 score on a scale
Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Suture Removal at 7 Days
n=21 Participants
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
Suture Removal at 10 Days
n=18 Participants
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
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
0 participants
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
2 participants
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
1 participants

Adverse Events

Suture Removal at 7 Days

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Suture Removal at 10 Days

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ellen Richards

Royal Devon and Exeter NHS Trust

Phone: 01392 411611

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place