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

NCT ID: NCT04870008

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2021-04-01

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.

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.

Conditions

Suture; Dermatologic Surgery; Scar; Cosmetic Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

2 mm

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

Group Type: ACTIVE_COMPARATOR

Suture

Intervention Type: PROCEDURE

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

5 mm

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

Group Type: ACTIVE_COMPARATOR

Suture

Intervention Type: PROCEDURE

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

Interventions

Suture

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Daniel Eisen, MD

Professor of Clinical Dermatology, Director of Dermatologic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, Davis

Sacramento, California, United States

Countries

United States

Other Identifiers

1508837

Identifier Type: -

Identifier Source: org_study_id