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

Scar 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: NCT04870008
• Other study ID #: 1508837
• Status: Completed
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: April 1, 2021

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2021
• Est. primary completion date: November 20, 2020
• 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 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

Related Conditions & MeSH terms

• Cosmetic Outcome
• Dermatologic Surgery
• Scar
• Suture

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Davis	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	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
Primary	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	Any complications from the treatment	Occurrence of any complications including: spitting sutures, dehiscence, infection, necrosis, bleeding, and hematoma	3-12 months