Cutaneous Sutures and Scar Cosmesis
Conditions
Keywords
Cutaneous Sutures, Scar Cosmesis, Linear Wound Closure, Wound Cosmesis
Brief summary
This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter spacing between sutures.
Detailed description
Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer. The deep layer dissolves naturally whereas the top layer may necessitate removal if non-absorbable sutures are used. This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter spacing between sutures. It is possible that fewer, more widely spaced sutures may leave more open space in the wound, leaving more tension to pull on those few sutures, possibly encouraging the wound to dehisce and make it harder to approximate the wound edges yielding a less cosmetically appealing scar compared to placing many closely approximated sutures which would decrease the tension and likely better approximate the wound edges yielding a more cosmetically appealing scar. On the other hand, the investigators may find that suture spacing has no effect on wound cosmesis and that placing fewer, more widely spaced sutures is much more time efficient. The investigators may also find that the effect of suture spacing on wound cosmesis is dependent on wound tension. For example, perhaps the suture pacing would have no effect on the cosmesis of a wound under no tension, however, for a wound under high tension, it is possible that many closely approximated sutures would yield better cosmetic results for the reasons listed above.
Interventions
DEVICEFast absorbing gut suture
Fast absorbing surgical gut suture is a strand of collagenous material
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Able to give informed consent themselves * Patient scheduled for cutaneous surgical procedure on the trunk and extremities with predicted primary closure * Willing to return for follow up visit.
Exclusion criteria
* Mentally handicapped * Unable to understand written and oral English * Incarceration * Under 18 years of age * Pregnant Women * Wounds with predicted closure length less than 4 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Posas Score | 3 months following procedure | Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin & 10 representing the most severe scar imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Width of Scar | 3 months following procedure | A secondary endpoint will include the width of the scar 1 cm from midline on each side. This measurement will be reported in mm |
| Erythema | 3 months following procedure | If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported |
Countries
United States
Participant flow
Recruitment details
This randomized clinical trial was conducted at the University of California, Davis dermatology clinic from November 28, 2017, to June 15, 2018.
Participants by arm
| Arm | Count |
|---|---|
| Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart Wound closed with sutures spaced 2 and 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Fast absorbing gut suture: Fast absorbing surgical gut suture is a strand of collagenous material | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart |
|---|---|
| Age, Continuous | 71.1 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Patient Posas Score
Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin & 10 representing the most severe scar imaginable.
Time frame: 3 months following procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast Absorbing Gut Suture Placed 2 mm Apart | Patient Posas Score | 10.2 score on a scale | Standard Deviation 4.7 |
| Fast Absorbing Gut Suture Placed 5 mm Apart | Patient Posas Score | 11.5 score on a scale | Standard Deviation 6.4 |
Secondary
Erythema
If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported
Time frame: 3 months following procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fast Absorbing Gut Suture Placed 2 mm Apart | Erythema | 0 Participants |
| Fast Absorbing Gut Suture Placed 5 mm Apart | Erythema | 0 Participants |
Secondary
Width of Scar
A secondary endpoint will include the width of the scar 1 cm from midline on each side. This measurement will be reported in mm
Time frame: 3 months following procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast Absorbing Gut Suture Placed 2 mm Apart | Width of Scar | 0.9 mm | Standard Deviation 0.6 |
| Fast Absorbing Gut Suture Placed 5 mm Apart | Width of Scar | 0.8 mm | Standard Deviation 0.4 |