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

• ClinicalTrials.gov Identifier: NCT03330041
• Recruitment Status: Completed
• First Posted: November 6, 2017
• Results First Posted: January 21, 2020
• Last Update Posted: May 12, 2021
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cutaneous Sutures and Scar Cosmesis	Device: Fast absorbing gut suture	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• 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).
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• 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.
• Actual Study Start Date: October 3, 2017
• Actual Primary Completion Date: August 9, 2018
• Actual Study Completion Date: August 9, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fast absorbing gut suture placed 2 mm apart; Wound closed with sutures spaced 2 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
Experimental: Fast absorbing gut suture placed 5 mm apart; 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

Outcome Measures

Primary Outcome Measures :

1. Patient Posas Score [ Time Frame: 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 Outcome Measures :

1. Width of Scar [ Time Frame: 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

2. Erythema [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

University of California, Davis, Department of Dermatology

Sacramento, California, United States, 95816

Sponsors and Collaborators

University of California, Davis

Investigators

• Principal Investigator: Daniel Eisen, M.D.; University of California, Davis

  Study Documents (Full-Text)

Documents provided by University of California, Davis:

Study Protocol and Statistical Analysis Plan  [PDF] October 30, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03330041
• Other Study ID Numbers: 1115596
• First Posted: November 6, 2017
• Results First Posted: January 21, 2020
• Last Update Posted: May 12, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by University of California, Davis:

Cutaneous Sutures; Scar Cosmesis; Linear Wound Closure; Wound Cosmesis

Additional relevant MeSH terms:

Wounds and Injuries