An interventional study of Fast absorbing gut suture in Cutaneous Sutures and Scar Cosmesis, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.
Sponsored by University of California, Davis · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Wound closed with sutures spaced 2 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Device: Fast absorbing gut suture
Wound closed with sutures spaced 5 millimeters apart will be treated in a simple, interrupted cutaneous suture pattern
Device: Fast absorbing gut suture
Fast absorbing surgical gut suture is a strand of collagenous material
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
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
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
This randomized clinical trial was conducted at the University of California, Davis dermatology clinic from November 28, 2017, to June 15, 2018.
| Milestone | All Participants |
|---|---|
| Started | 50 |
| Completed | 48 |
| Not completed | 2 |
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.
| score on a scale | Fast Absorbing Gut Suture Placed 2 mm Apart | Fast Absorbing Gut Suture Placed 5 mm Apart |
|---|---|---|
| Patient Posas Score | 10.2 ± 4.7 | 11.5 ± 6.4 |
A secondary endpoint will include the width of the scar 1 cm from midline on each side. This measurement will be reported in mm
| mm | Fast Absorbing Gut Suture Placed 2 mm Apart | Fast Absorbing Gut Suture Placed 5 mm Apart |
|---|---|---|
| Width of Scar | 0.9 ± 0.6 | 0.8 ± 0.4 |
If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported
| Participants | Fast Absorbing Gut Suture Placed 2 mm Apart | Fast Absorbing Gut Suture Placed 5 mm Apart |
|---|---|---|
| Erythema | 0 | 0 |
Collected over At 3-Month Follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fast Absorbing Gut Suture Placed 2 mm Apart | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Fast Absorbing Gut Suture Placed 5 mm Apart | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart |
|---|---|
| Mean | 71.1 ± 11.4 |
| Sex: Female, Male(Participants) | Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart |
|---|---|
| Female | 7 |
| Male | 43 |
| Race (NIH/OMB)(Participants) | Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 50 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Fast Absorbing Gut Suture Placed 2 mm and 5 Mmapart |
|---|---|
| United States | 50 |
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University of California, Davis