Clinical trial NCT06288009: Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds
Official title: Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scarring
Keywords: Running Locking Suture
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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 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

Primary outcomes:
measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
timeFrame: 3 months
Secondary outcomes:
measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
timeFrame: 3 months
measure: Width of Scar as measured using Trace-to-Tape Method
timeFrame: 3 months
measure: Complications or Adverse Events from Treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis - Dermatology Department
state: California
Study officials:
affiliation: University of California, Davis - Dermatology
name: Daniel Eisen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kantor J Kantor, Jonathan.
citation: 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.
citation: MacDougal BA. Locking a continuous running suture. J Am Coll Surg. 1995 Dec;181(6):563-4. No abstract available.
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.
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.