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

NCT ID: NCT03330041

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-03
• Study Completion Date: 2018-08-09

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.

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.

Conditions

Cutaneous Sutures and Scar Cosmesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Fast absorbing gut suture

Intervention Type: DEVICE

Fast absorbing surgical gut suture is a strand of collagenous material

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

Group Type: EXPERIMENTAL

Fast absorbing gut suture

Intervention Type: DEVICE

Fast absorbing surgical gut suture is a strand of collagenous material

Interventions

Fast absorbing gut suture

Fast absorbing surgical gut suture is a strand of collagenous material

Intervention Type: DEVICE

Eligibility 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

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

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eisen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis, Department of Dermatology

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30649154 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1115596

Identifier Type: -

Identifier Source: org_study_id