Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations

NCT06550999 | Not Yet Recruiting FDA Device

• 1 other identifier: 4338
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Laceration

Keywords

Adhesive strips; Sutures; Laceration repair; Cosmesis; Scar healing

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Time to repair laceration

  Assessed immediately after the intervention

• Laceration/scar length and width

  Assessed immediately after the intervention and two months after the intervention

• Complications during and/or after the repair

  Assessed immediately after the intervention and two months after the intervention

Study Arms (2)

Adhesive strip repair

EXPERIMENTAL

In this arm, patients will have their facial laceration properly cleaned and repaired with adhesive strips.

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.

Procedure: Laceration repair with sutures

Interventions

Laceration repair with adhesive strips DEVICE

Repair of the patient's facial laceration with adhesive strips

Also known as: Adhesive strips, Steri-Strips, STERI-STRIP ANTIMICROBIAL SKIN CLOS

Adhesive strip repair

Laceration repair with sutures PROCEDURE

Repair of the patient's facial laceration with sutures

Suture repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult (\>18-years-old)
• Small (\<2.5 cm) and simple facial lacerations requiring repair

You may not qualify if:

• Patients less than 18 years old
• Pregnant females
• Incarcerated individuals

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Jeffry Nahmias, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffry Nahmias, M.D.

CONTACT

714-506-8076; jnahmias@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Following informed consent, patients will be randomized to either the adhesive strip repair group or the suture repair group for their facial laceration. The patient and care provider will therefore know which group they are part of. 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. The investigator and outcomes assessor will be blinded to the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 13, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)