Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm)

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

It is standard teaching that the top layer of sutures should be placed 3-5mm from the wound edge. However, there is lack of data regarding the most optimal placement of sutures from the wound edge for the best cosmetic outcome. The research team wish to determine if sutures placed closer to the wound edge (2mm) or farther from the wound edge (5mm) makes a difference in the cosmetic outcome of the scar.

Study Overview

• Status: Completed
• Conditions: Scar; Suture; Dermatologic Surgery; Cosmetic Outcome
• Intervention / Treatment: Procedure: Suture

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. Given the overall lack of evidence in the literature, the choice of suturing technique is largely dependent on the surgeon's preference.

This study aims to investigate whether the distance of simple cuticular suture placement from the wound edge affects wound cosmesis on the head and neck. In other words, we would like to determine which of the following yields a more cosmetically appealing scar: cuticular sutures placed 2 mm from wound edge or cuticular sutures placed 5mm from wound edge.

Although a Dermatologic surgery textbook states that simple cuticular sutures should be placed 3 mm-5 mm from the wound edge1, there have not been any studies to evaluate the optimal distance from wound edge to achieve the most cosmetically appealing scar.

Overall, there is paucity of data regarding the optimal distance of cuticular suture placement from the wound edge to achieve the most cosmetically appealing scar. The research team hope that the study will provide new insight in cutaneous surgery.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18 years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure on the head and neck with predicted primary closure
• Willing to return for follow up visit

Exclusion Criteria:

• Mentally handicapped
• Incarceration
• Under 18 years of age
• Pregnant Women
• Wounds with predicted closure length less than 3 cm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2 mm; The side of patient's scar that will receive the sutures placed at 2 mm from wound edge.	Procedure: Suture; The side of patient's scar that will receive the sutures placed at 2 or 5 mm from wound edge.
Active Comparator: 5 mm; The side of patient's scar that will receive the sutures placed at 5 mm from wound edge.	Procedure: Suture; The side of patient's scar that will receive the sutures placed at 2 or 5 mm from wound edge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score of two blinded reviewers using the patient observer scar assessment score	At the follow-up visit, two blinded observers will record their scores independently using the POSAS (Patient and Observer Scar Assessment Scale) instrument. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 10 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation). The total score of both scales can be simply calculated by summing up the scores of each of the six items.	3-12 months
The mean scar width using the trace-to-tape method at the assessment visit	The trace-to-tape method is an objective outcome measure for linear postoperative scars. Mean scar width in mm.	3-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any complications from the treatment	Occurrence of any complications including: spitting sutures, dehiscence, infection, necrosis, bleeding, and hematoma	3-12 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1508837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No