ScarringNCT06288009
Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds
A study testing Running locking suture and Standard running suture in people with Scarring, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scarring
- What is being tested?
- Running locking suture and Standard running suture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Incarceration
- Under 18 years of age
- Pregnant Women
- Unable to understand written and oral English
- Wounds with predicted closure length less than 3cm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis - Dermatology Department
Sacramento, California, 95816
John Robb, BS, 916-551-2636, jmrobb@ucdavis.edu
Daniel Eisen, MD, 916-551-2611, dbeisen@ucdavis.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Scarring
- Being tested
- Running locking suture, Standard running suture
- Keywords
- Running Locking Suture
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running locking sutureProcedure or surgery
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 sutureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Running locking suture; Procedure: Standard running suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ScarringStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, MD, Principal investigator, University of California, Davis - Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288009
- Sponsor's protocol ID
- 2135389
- Status last verified
- Dec 2025
- First submitted
- 23 Feb 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kantor J Kantor, Jonathan.
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.
PubMed 17545862MacDougal BA. Locking a continuous running suture. J Am Coll Surg. 1995 Dec;181(6):563-4. No abstract available.
PubMed 7582234Schlechter 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.
PubMed 7944193Wong 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.
PubMed 8454786
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT06288009
- Acronym / sponsor ID
- 2135389
- Conditions
- Scarring
- Keywords
- Running Locking Suture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Layered Closure with Running Locking Suture on Side A | Experimental | Procedure: Running locking suture, Procedure: Standard running sutureFor 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. |
| Layered Closure with Running Locking Suture on Side B | Experimental | Procedure: Running locking suture, Procedure: Standard running sutureFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Incarceration
- Under 18 years of age
- Pregnant Women
- Unable to understand written and oral English
- Wounds with predicted closure length less than 3cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Running locking sutureIn 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 or surgery | Layered Closure with Running Locking Suture on Side A, Layered Closure with Running Locking Suture on Side B |
| Standard running sutureIn 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. | Procedure or surgery | Layered Closure with Running Locking Suture on Side A, Layered Closure with Running Locking Suture on Side B |
Primary outcome
Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Time frame: 3 months
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 secondary outcomes
Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
Time frame: 3 months
Width of Scar as measured using Trace-to-Tape Method
Time frame: 3 months
Complications or Adverse Events from Treatment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- BackgroundKantor J Kantor, Jonathan.
- Background: PubMed 17545862Joshi 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.
- Background: PubMed 7582234MacDougal BA. Locking a continuous running suture. J Am Coll Surg. 1995 Dec;181(6):563-4. No abstract available.
- Background: PubMed 7944193Schlechter 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.
- Background: PubMed 8454786Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Eisen, MD principal investigator
University of California, Davis - Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running locking suture and Standard running suture in people with Scarring, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Robb, BS, BA (9165512636, jmrobb@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288009, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.