- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06550999
Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeffry Nahmias, M.D.
- Phone Number: 714-506-8076
- Email: jnahmias@hs.uci.edu
Study Locations
-
-
California
-
Orange, California, United States, 92868
- University of California Irvine
-
Contact:
- Jeffry Nahmias, M.D.
- Email: jnahmias@hs.uci.edu
-
Principal Investigator:
- Jeffry Nahmias, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All adult (>18-years-old)
- Small (<2.5 cm) and simple facial lacerations requiring repair
Exclusion Criteria:
- Patients less than 18 years old
- Pregnant females
- Incarcerated individuals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adhesive strip repair
In this arm, patients will have their facial laceration properly cleaned and repaired with adhesive strips.
|
Repair of the patient's facial laceration with adhesive strips
Other Names:
|
|
Experimental: Suture repair
In this arm, patients will have their facial laceration properly cleaned and repaired with sutures of any material.
|
Repair of the patient's facial laceration with sutures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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"
|
Assessed immediately after the intervention
|
|
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")
|
Assessed immediately after the intervention
|
|
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)
|
Assessed immediately after the intervention
|
|
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).
|
Assessed two months after the intervention
|
|
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)
|
Assessed two months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to repair laceration
Time Frame: Assessed immediately after the intervention
|
The amount of time lapsed in repairing the laceration
|
Assessed immediately after the intervention
|
|
Laceration/scar length and width
Time Frame: Assessed immediately after the intervention and two months after the intervention
|
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
Time Frame: Assessed immediately after the intervention and two months after the intervention
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffry Nahmias, M.D., University of California, Irvine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4338
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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