Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
NCT Number: NCT06550999
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Facial Laceration
Interventions: PROCEDURE: Laceration repair with adhesive strips|PROCEDURE: Laceration repair with sutures
Sponsor: University of California, Irvine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: University of California Irvine, Orange, California, 92868, United States

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.

Primary Outcome Measures: Patient pain score, Visual analogue scale (VAS) - 10-cm line representing a continuum from "no pain" to "worst pain imaginable", 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"), 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), 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)., 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), Assessed two months after the intervention
Secondary Outcome Measures: Time to repair laceration, The amount of time lapsed in repairing the laceration, Assessed immediately after the intervention|Laceration/scar length and width, The length and width in centimeters of the subject's laceration/scar, 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, Assessed immediately after the intervention and two months after the intervention