Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds

NCT06288009 | Recruiting

• 1 other identifier: 2135389
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring.

Conditions

Scarring

Keywords

Running Locking Suture

Outcome Measures

Primary Outcomes (1)

• Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

  3 months

Secondary Outcomes (3)

• Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  3 months

• Width of Scar as measured using Trace-to-Tape Method

  3 months

• Complications or Adverse Events from Treatment

  3 months

Study Arms (2)

Layered Closure with Running Locking Suture on Side A

EXPERIMENTAL

For all participants, one wound side half will be labeled as A and the other side as B. The bottom (subcutaneous) layer of the entire wound will receive the normal stitching. For the upper (cutaneous) layer, Side A will be closed with a running locking suture, and Side B will be closed with a standard running suture.

Procedure: Running locking suture; Procedure: Standard running suture

Layered Closure with Running Locking Suture on Side B

EXPERIMENTAL

For all participants, one wound side half will be labeled as A and the other side as B. The bottom (subcutaneous) layer of the entire wound will receive the normal stitching. For the upper (cutaneous) layer, Side B will be closed with a running locking suture, and Side A will be closed with a standard running suture.

Procedure: Running locking suture; Procedure: Standard running suture

Interventions

Standard running suture PROCEDURE

In standard running sutures, the first anchoring knot is made at one end of the wound, and all of the suture material is pulled through after completing the throw. This is repeated until reaching the end of the wound, where the suture material is then tied.

Layered Closure with Running Locking Suture on Side A; Layered Closure with Running Locking Suture on Side B

Running locking suture PROCEDURE

In running locking sutures, the first anchoring knot is made at one end of the wound, and a loop of suture is left from the beginning of the throw. The needle is then passed through the loop of suture, locking the suture in place. This is repeated until reaching the end of the wound, where the suture material is then tied to the loop using an instrument tie for the final throw.

Layered Closure with Running Locking Suture on Side A; Layered Closure with Running Locking Suture on Side B

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 or neck with predicted primary closure
• Willing to return for follow up visit

You may not qualify if:

• Incarceration
• Under 18 years of age
• Pregnant Women
• Unable to understand written and oral English
• Wounds with predicted closure length less than 3cm

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

RECRUITING

Related Publications (5)

• Kantor J Kantor, Jonathan.

  BACKGROUND

• Joshi AS, Janjanin S, Tanna N, Geist C, Lindsey WH. Does suture material and technique really matter? Lessons learned from 800 consecutive blepharoplasties. Laryngoscope. 2007 Jun;117(6):981-4. doi: 10.1097/MLG.0b013e31804f54bd.

  PMID: 17545862 BACKGROUND

• MacDougal BA. Locking a continuous running suture. J Am Coll Surg. 1995 Dec;181(6):563-4. No abstract available.

  PMID: 7582234 BACKGROUND

• Schlechter B, Guyuron B. A comparison of different suture techniques for microvascular anastomosis. Ann Plast Surg. 1994 Jul;33(1):28-31. doi: 10.1097/00000637-199407000-00006.

  PMID: 7944193 BACKGROUND

• Wong NL. The running locked intradermal suture. A cosmetically elegant continuous suture for wounds under light tension. J Dermatol Surg Oncol. 1993 Jan;19(1):30-6. doi: 10.1111/j.1524-4725.1993.tb03326.x.

  PMID: 8454786 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Eisen, MD

  University of California, Davis - Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Robb, BS, BA

CONTACT

9165512636; jmrobb@ucdavis.edu

Keemberly Kim, MD

CONTACT

9168161525; keekim@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two blinded observers will record their scores independently using the POSAS instrument.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)