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

Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Scarring
• Intervention / Treatment: Procedure: Running locking suture; Procedure: Standard running suture

Detailed Description

Following cutaneous surgical procedures, scar formation is inevitable. Reducing the degree of scar formation and achieving the best aesthetic outcome remains prominent within the dermatological literature.

Wound closure can be achieved by a variety of suturing techniques. After the dermis is closed using deep sutures, the epidermis is closed with a second layer of sutures for additional reinforcement. Approximating the epidermis is commonly performed with running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches.

Running locking sutures are another technique that can achieve secondary layer closure of wounds. Like the running suture, the first anchoring knot is made at one end of the wound, but rather than pulling all of the suture material through after completing the throw, a loop of suture is left from the beginning of the throw, and 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. This technique may achieve better hemostasis by improving eversion and providing more equal tension across all loops of the running suture.

To our knowledge, the impact of scar cosmesis and rate of post-operative complications using a running locking suture technique in comparison to using standard running sutures for primary linear repair of surgical wounds has not been studied. This study seeks to determine the effectiveness of an alternative suturing technique for epidermal approximation by using individuals as their own controls in a split-scar model.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Robb, BS, BA; Phone Number: 9165512636; Email: jmrobb@ucdavis.edu
• Study Contact Backup: Name: Keemberly Kim, MD; Phone Number: 9168161525; Email: keekim@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Recruiting
      • University of California, Davis - Dermatology Department
      • Principal Investigator: Daniel Eisen, MD
      • Contact: Daniel Eisen, MD; Phone Number: 916-551-2611; Email: dbeisen@ucdavis.edu
      • Contact: John Robb, BS; Phone Number: 916-551-2636; Email: jmrobb@ucdavis.edu
      • Sub-Investigator: Keemberly Kim, MD
      • Sub-Investigator: Samantha Daniel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Layered Closure with Running Locking Suture on Side A; 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; 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.; Procedure: Standard running suture; 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.
Experimental: Layered Closure with Running Locking Suture on Side B; 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; 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.; Procedure: Standard running suture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Width of Scar as measured using Trace-to-Tape Method	The trace-to-tape method is an objective measure for linear postoperative scars. The mean scar width will be determined using the trace-to-tape method. The surface area of the scar will be collected by tracing the scar with a water-based gel pen. While still wet, the gel residue will be lifted from the skin with clear packing tape and transferred on a sheet of paper.	3 months
Complications or Adverse Events from Treatment	For example, if one half of the scar has more associated erythema, as measured using the Trace-to-Tape method, then it will be recorded. Other complications from the treatment will also be recorded.	3 months
Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)	This is the patient portion of the POSAS assessment, which will be independently recorded. The patient scale of the POSAS consists of six items (pain, itch, thickness, color, stiffness, and irregularity). All items are scored on a scale ranging from 1 ("as normal skin") to 10 ("yes, very different"). The sum of the six items results in a total score of the POSAS patient scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.	3 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Daniel Eisen, MD, University of California, Davis - Dermatology

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Running Locking Suture
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Pathological Conditions, Signs and Symptoms; Cicatrix
• Other Study ID Numbers: 2135389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No