Facial LacerationNCT06550999
Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
A study testing Laceration repair with adhesive strips and Laceration repair with sutures in people with Facial Laceration, run by University of California, Irvine at 1 site in United States.
Trial summary
There are a variety of techniques utilized to close lacerations, including but not limited to, traditional sutures, staples, adhesive strips, and skin glue. While closing open wounds and preventing infection are the primary goals of laceration repair, physicians are also concerned with minimizing scar formation and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Laceration
- What is being tested?
- Laceration repair with adhesive strips and Laceration repair with sutures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to May 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adult (>18-years-old)
- Small (<2.5 cm) and simple facial lacerations requiring repair
Who cannot join
- Patients less than 18 years old
- Pregnant females
- Incarcerated individuals
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
University of California Irvine
Orange, California, 92868
Jeffry Nahmias, M.D., jnahmias@hs.uci.edu
Jeffry Nahmias, M.D.
About this study
Official title: Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations: A Randomized Controlled Trial
There are a variety of techniques utilized to close lacerations, including but not limited to, traditional sutures, staples, adhesive strips, and skin glue. While closing open wounds and preventing infection are the primary goals of laceration repair, physicians are also concerned with minimizing scar formation and providing the best cosmetic outcomes for the patient. Specifically, the skin on the face is a sensitive area where cosmetic outcome is of high importance, and several laceration repair techniques have been devised for closing facial wounds.
Sutures have traditionally been used to close wounds in various types of tissue, and it is still very commonly used in the clinical setting. Adhesive strips (also known under the brand names of Steri-Strips, Curi-strips, Nichi-Strips, and Suture Strips) are another method to repair lacerations superficially. Due to their superficial application and ease of use, adhesive strips may help minimize scar formation and may result in less pain and complications for the patient when compared to conventional sutures.
Therefore, the aim of this study is to determine whether repair of small, simple facial lacerations with adhesive strips results in better patient experiences and better cosmetic outcomes than sutures. The investigators hypothesize that wounds repaired with adhesive strip will have higher patient satisfaction scores and better cosmetic outcomes.
Read the detailed description
This is a prospective, single-blinded, randomized controlled trial taking place in a single center. Patients will be identified in the emergency room as they present to the hospital and meet eligibility criteria. Following informed consent, patients will be randomized in a 1:1 ratio to either the adhesive strip repair or the suture repair group. Randomization will be dictated by a validated online software utilizing the Wichmann-Hill random number generator. A password-protected randomization database that is only accessible to the study team will be utilized.
After randomization to their respective laceration repair group, patients will be surveyed by the study team to assess their experience, satisfaction, and pain scores during the laceration repair. Approximately two months after their initial laceration repair, the patients will be contacted securely via phone call or email to assess if they had any complications and to assess their satisfaction and cosmetic rating of their laceration scar. Additionally, the subjects will be instructed to take pictures and/or videos of their scar and send it securely to the study team via UCI Epic MyChart (or a HIPAA-compliant encrypted email if MyChart is unavailable). These photos and videos will be de-identified and stored securely on a password-encrypted folder where a blinded evaluator will score the scars with a validated scar assessment tool. Patients will be instructed to only take photos/videos of their scar area and not any other major areas of their face that can be identified. Following the conclusion of the study, all patient identifiers and photos/videos will be destroyed to preserve patient privacy.
All survey data will be collected and entered into a REDCap database. Data collection will include demographics, phone/email contact information, patient satisfaction scores with the laceration repair, patient pain scores, patient scar cosmetic rating, presence of complications, and patient responses to questions about their general experience during the laceration repair and healing time period.
- Conditions
- Facial Laceration
- Being tested
- Laceration repair with adhesive strips, Laceration repair with sutures
- Keywords
- Adhesive strips, Sutures, Laceration repair, Cosmesis, Scar healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laceration repair with adhesive stripsDevice
Also called Adhesive strips, Steri-Strips, STERI-STRIP ANTIMICROBIAL SKIN CLOS
Repair of the patient's facial laceration with adhesive strips
Laceration repair with suturesProcedure or surgery
Repair of the patient's facial laceration with sutures
| Study group | Role | What they receive |
|---|---|---|
| Adhesive strip repair | Experimental | In this arm, patients will have their facial laceration properly cleaned and repaired with adhesive strips. Receives: Device: Laceration repair with adhesive strips |
| Suture repair | Experimental | In this arm, patients will have their facial laceration properly cleaned and repaired with sutures of any material. Receives: Procedure: Laceration repair with sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain score
Visual analogue scale (VAS) - 10-cm line representing a continuum from "no pain" to "worst pain imaginable"
Measured: Assessed immediately after the intervention
Patient's satisfaction and experience during laceration repair
Measured on a Likert-scale (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) and measured with a visual analogue scale (VAS) ("not satisfied" and to "fully satisfied")
Measured: Assessed immediately after the intervention
Patient's cosmetic score of the laceration immediately after repair
Measured on a visual analogue scale (VAS) - 100-mm visual analogue scale for cosmetic assessment of wound (0 = worst scar and 100 = best scar)
Measured: Assessed immediately after the intervention
Patient's cosmetic score of the laceration scar
Measured via the Patient and Observer Scar Assessment Scale (POSAS) - a validated cosmetic score assessment for wounds from the patient's perspective. Each item of the POSAS is rated on a 5-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 5 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation).
Measured: Assessed two months after the intervention
Evaluator's cosmetic score of the wound assessed from a photograph
Measured on the Stoney Brook Scar Evaluation Scale (SBSES) - a validated cosmetic score assessment of scars from the observer's perspective using a photograph. Scars are assigned either 0 or 1 point each for the presence or absence of the following: width greater than 2 mm, elevation or depression, discoloration, suture or staple marks, and overall poor appearance. A total cosmetic score is generated by adding the individual scores from each category ranging from 0 (worst) to 5 (best)
Measured: Assessed two months after the intervention
Secondary outcomes (3)
Time to repair laceration
The amount of time lapsed in repairing the laceration
Measured: Assessed immediately after the intervention
Laceration/scar length and width
The length and width in centimeters of the subject's laceration/scar
Measured: Assessed immediately after the intervention and two months after the intervention
Complications during and/or after the repair
Complications during the procedure will be evaluated by the study team by retrieving data from the medical chart, observing the laceration repair in real time, or surveying the patient after the laceration repair. Post-procedural complications will be evaluated by following up with patients via phone call or secure email
Measured: Assessed immediately after the intervention and two months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study startAug 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial LacerationStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-blinded, randomized controlled trial taking place in a single center. Patients will be identified in the emergency room as they present to the hospital and meet eligibility criteria. Following informed consent, patients will be randomized in a 1:1 ratio to either the adhesive strip repair or the suture repair group. Randomization will be dictated by a validated online software utilizing the Wichmann-Hill random number generator. Randomization and allocation concealment will be managed by a nominated independent individual(s) not involved in patient care or data extraction/analysis. A password-protected randomization database that is only accessible to the study team will be utilized.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffry Nahmias, MD, University of California, Irvine
- Investigators
- Jeffry Nahmias, M.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550999
- Sponsor's protocol ID
- 4338
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06550999
- Acronym / sponsor ID
- 4338
- Conditions
- Facial Laceration
- Keywords
- Adhesive strips, Sutures, Laceration repair, Cosmesis, Scar healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Aug 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.
There are a variety of techniques utilized to close lacerations, including but not limited to, traditional sutures, staples, adhesive strips, and skin glue. While closing open wounds and preventing infection are the primary goals of laceration repair, physicians are also concerned with minimizing scar formation and providing the best cosmetic outcomes for the patient. Specifically, the skin on the face is a sensitive area where cosmetic outcome is of high importance, and several laceration repair techniques have been devised for closing facial wounds.
Sutures have traditionally been used to close wounds in various types of tissue, and it is still very commonly used in the clinical setting. Adhesive strips (also known under the brand names of Steri-Strips, Curi-strips, Nichi-Strips, and Suture Strips) are another method to repair lacerations superficially. Due to their superficial application and ease of use, adhesive strips may help minimize scar formation and may result in less pain and complications for the patient when compared to conventional sutures.
Therefore, the aim of this study is to determine whether repair of small, simple facial lacerations with adhesive strips results in better patient experiences and better cosmetic outcomes than sutures. The investigators hypothesize that wounds repaired with adhesive strip will have higher patient satisfaction scores and better cosmetic outcomes.
Detailed description
This is a prospective, single-blinded, randomized controlled trial taking place in a single center. Patients will be identified in the emergency room as they present to the hospital and meet eligibility criteria. Following informed consent, patients will be randomized in a 1:1 ratio to either the adhesive strip repair or the suture repair group. Randomization will be dictated by a validated online software utilizing the Wichmann-Hill random number generator. A password-protected randomization database that is only accessible to the study team will be utilized.
After randomization to their respective laceration repair group, patients will be surveyed by the study team to assess their experience, satisfaction, and pain scores during the laceration repair. Approximately two months after their initial laceration repair, the patients will be contacted securely via phone call or email to assess if they had any complications and to assess their satisfaction and cosmetic rating of their laceration scar. Additionally, the subjects will be instructed to take pictures and/or videos of their scar and send it securely to the study team via UCI Epic MyChart (or a HIPAA-compliant encrypted email if MyChart is unavailable). These photos and videos will be de-identified and stored securely on a password-encrypted folder where a blinded evaluator will score the scars with a validated scar assessment tool. Patients will be instructed to only take photos/videos of their scar area and not any other major areas of their face that can be identified. Following the conclusion of the study, all patient identifiers and photos/videos will be destroyed to preserve patient privacy.
All survey data will be collected and entered into a REDCap database. Data collection will include demographics, phone/email contact information, patient satisfaction scores with the laceration repair, patient pain scores, patient scar cosmetic rating, presence of complications, and patient responses to questions about their general experience during the laceration repair and healing time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-blinded, randomized controlled trial taking place in a single center. Patients will be identified in the emergency room as they present to the hospital and meet eligibility criteria. Following informed consent, patients will be randomized in a 1:1 ratio to either the adhesive strip repair or the suture repair group. Randomization will be dictated by a validated online software utilizing the Wichmann-Hill random number generator. Randomization and allocation concealment will be managed by a nominated independent individual(s) not involved in patient care or data extraction/analysis. A password-protected randomization database that is only accessible to the study team will be utilized.
| Arm | Type | Receives |
|---|---|---|
| Adhesive strip repair | Experimental | Device: Laceration repair with adhesive stripsIn this arm, patients will have their facial laceration properly cleaned and repaired with adhesive strips. |
| Suture repair | Experimental | Procedure: Laceration repair with suturesIn this arm, patients will have their facial laceration properly cleaned and repaired with sutures of any material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult (>18-years-old)
- Small (<2.5 cm) and simple facial lacerations requiring repair
Key exclusion criteria (3 listed)
- Patients less than 18 years old
- Pregnant females
- Incarcerated individuals
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 |
|---|---|---|
| Laceration repair with adhesive stripsAlso: Adhesive strips, Steri-Strips, STERI-STRIP ANTIMICROBIAL SKIN CLOSRepair of the patient's facial laceration with adhesive strips | Device | Adhesive strip repair |
| Laceration repair with suturesRepair of the patient's facial laceration with sutures | Procedure or surgery | Suture repair |
Primary outcome
Patient pain score
Time frame: Assessed immediately after the intervention
Visual analogue scale (VAS) - 10-cm line representing a continuum from "no pain" to "worst pain imaginable"
Patient's satisfaction and experience during laceration repair
Time frame: Assessed immediately after the intervention
Measured on a Likert-scale (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) and measured with a visual analogue scale (VAS) ("not satisfied" and to "fully satisfied")
Patient's cosmetic score of the laceration immediately after repair
Time frame: Assessed immediately after the intervention
Measured on a visual analogue scale (VAS) - 100-mm visual analogue scale for cosmetic assessment of wound (0 = worst scar and 100 = best scar)
Patient's cosmetic score of the laceration scar
Time frame: Assessed two months after the intervention
Measured via the Patient and Observer Scar Assessment Scale (POSAS) - a validated cosmetic score assessment for wounds from the patient's perspective. Each item of the POSAS is rated on a 5-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 5 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation).
Evaluator's cosmetic score of the wound assessed from a photograph
Time frame: Assessed two months after the intervention
Measured on the Stoney Brook Scar Evaluation Scale (SBSES) - a validated cosmetic score assessment of scars from the observer's perspective using a photograph. Scars are assigned either 0 or 1 point each for the presence or absence of the following: width greater than 2 mm, elevation or depression, discoloration, suture or staple marks, and overall poor appearance. A total cosmetic score is generated by adding the individual scores from each category ranging from 0 (worst) to 5 (best)
3 secondary outcomes
Time to repair laceration
Time frame: Assessed immediately after the intervention
Laceration/scar length and width
Time frame: Assessed immediately after the intervention and two months after the intervention
Complications during and/or after the repair
Time frame: Assessed immediately after the intervention and two months after the intervention
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 12 Feb 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Jeffry Nahmias, M.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laceration repair with adhesive strips and Laceration repair with sutures in people with Facial Laceration, run by University of California, Irvine 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Feb 2026. 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 Jeffry Nahmias, M.D. (714-506-8076, jnahmias@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient pain score (time frame: Assessed immediately after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.