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

NCT04870008 | Completed

• 1 other identifier: 1508837
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suture; Dermatologic Surgery; Scar; Cosmetic Outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Any complications from the treatment

  3-12 months

Study Arms (2)

2 mm

ACTIVE COMPARATOR

The side of patient's scar that will receive the sutures placed at 2 mm from wound edge.

Procedure: Suture

5 mm

ACTIVE COMPARATOR

The side of patient's scar that will receive the sutures placed at 5 mm from wound edge.

Procedure: Suture

Interventions

Suture PROCEDURE

The side of patient's scar that will receive the sutures placed at 2 or 5 mm from wound edge.

2 mm; 5 mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Sutures

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Dermatology, Director of Dermatologic Surgery

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: November 20, 2019
• Primary Completion: November 20, 2020
• Study Completion: April 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

US (1)