Clinical trial NCT03330041: Suturing Distance From the Wound Edge, 2 mm vs 5 mm
Official title: Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm) From Wound Edge on the Closure of Linear Wounds on the Head and Neck: a Randomized Evaluator Blinded Split Wound Comparative Effective Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Sutures and Scar Cosmesis
Keywords: Cutaneous Sutures
Scar Cosmesis
Linear Wound Closure
Wound Cosmesis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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).
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Posas Score
timeFrame: 3 months following procedure
Secondary outcomes:
measure: Width of Scar
timeFrame: 3 months following procedure
measure: Erythema
timeFrame: 3 months following procedure
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sklar LR, Pourang A, Armstrong AW, Dhaliwal SK, Sivamani RK, Eisen DB. Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck: A Randomized Clinical Trial. JAMA Dermatol. 2019 Mar 1;155(3):321-326. doi: 10.1001/jamadermatol.2018.5057.