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

Scarring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288009
• Other study ID #: 2135389
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: University of California, Davis
• Contact: John Robb, BS, BA
• Phone: 9165512636
• Email: jmrobb[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: March 1, 2025
• 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 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

Related Conditions & MeSH terms

• Scarring
• Surgical Wound

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Davis - Dermatology Department	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Erratum In: Laryngoscope. 2007 Aug;117(8):1510. Lindsey, Charlie [corrected to Lindsey, William H]. — View Citation

Kantor J Kantor, Jonathan.

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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