Clinical trial NCT06550999: Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
Official title: Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Facial Laceration
Keywords: Adhesive strips
Sutures
Laceration repair
Cosmesis
Scar healing
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria: All adult (\>18-years-old) patients presenting with small (\<2.5 cm) and simple facial lacerations requiring repair

Exclusion Criteria:

* Patients less than 18 years old, pregnant females, incarcerated individuals

Primary outcomes:
measure: Patient pain score
timeFrame: Assessed immediately after the intervention
measure: Patient's satisfaction and experience during laceration repair
timeFrame: Assessed immediately after the intervention
measure: Patient's cosmetic score of the laceration immediately after repair
timeFrame: Assessed immediately after the intervention
measure: Patient's cosmetic score of the laceration scar
timeFrame: Assessed two months after the intervention
measure: Evaluator's cosmetic score of the wound assessed from a photograph
timeFrame: Assessed two months after the intervention
Secondary outcomes:
measure: Time to repair laceration
timeFrame: Assessed immediately after the intervention
measure: Laceration/scar length and width
timeFrame: Assessed immediately after the intervention and two months after the intervention
measure: Complications during and/or after the repair
timeFrame: Assessed immediately after the intervention and two months after the intervention
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Jeffry Nahmias, M.D.
role: PRINCIPAL_INVESTIGATOR
References: