Suturing Distance From the Wound Edge, 2 mm vs 5 mm

Cutaneous Sutures and Scar Cosmesis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330041
• Other study ID #: 1115596
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: August 9, 2018

Study information

• Verified date: April 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 9, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Sutures and Scar Cosmesis
• Wounds and Injuries

Intervention

Device:
• Fast absorbing gut suture
Fast absorbing surgical gut suture is a strand of collagenous material

Locations

Country	Name	City	State
United States	University of California, Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months following procedure
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	3 months following procedure
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	3 months following procedure