Interrupted Subdermal Suture
Conditions
Keywords
Subdermal, Suture, Wound Closure, Wound Cosmesis
Brief summary
This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter 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 layer and a top layer. The deep layer dissolves naturally whereas the top layer must be removed. This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter 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, we 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 investigator 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
DEVICEVicryl absorbable suture
Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 and Observer Scar Assessment Scale - Reviewer 1 | 3 months following procedure | The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes. |
| Patient and Observer Scar Assessment Scale - Reviewer 2 | 3 months following procedure | The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes. |
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 |
| Complications | 3 months following procedure | Any complications including suture reaction, dehiscence, infection, necrosis, bleeding, and hematoma |
Countries
United States
Participant flow
Recruitment details
The surgeons recruited patients for the study from their cutaneous surgical practices.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.2 years STANDARD_DEVIATION 7.7 |
| Closure Length | 5.89 centimeters STANDARD_DEVIATION 1.2 |
| Indication for Surgery Excision | 0 Wound halves |
| Indication for Surgery Mohs | 50 Wound halves |
| Location of Surgical Procedure Cheeks | 18 Wound halves |
| Location of Surgical Procedure Chin | 1 Wound halves |
| Location of Surgical Procedure Forehead | 6 Wound halves |
| Location of Surgical Procedure Neck | 11 Wound halves |
| Location of Surgical Procedure Post-auricular | 1 Wound halves |
| Location of Surgical Procedure Pre-auricular | 8 Wound halves |
| Location of Surgical Procedure Temple | 10 Wound halves |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Wound halves |
| Race (NIH/OMB) Asian | 0 Wound halves |
| Race (NIH/OMB) Black or African American | 0 Wound halves |
| Race (NIH/OMB) More than one race | 0 Wound halves |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Wound halves |
| Race (NIH/OMB) Unknown or Not Reported | 0 Wound halves |
| Race (NIH/OMB) White | 50 Wound halves |
| Sex: Female, Male Female | 22 Wound halves |
| Sex: Female, Male Male | 39 Wound halves |
| Surgeon Experience Attending | 17 Wound halves |
| Surgeon Experience Fellow | 32 Wound halves |
| Surgeon Experience Resident | 2 Wound halves |
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
None listed