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

Официальное название

Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Laceration repair with adhesive strips
  Repair of the patient's facial laceration with adhesive strips
• Процедура Laceration repair with sutures
  Repair of the patient's facial laceration with sutures

Первичные конечные точки

• Patient pain score [Срок оценки: Assessed immediately after the intervention]
• Patient's satisfaction and experience during laceration repair [Срок оценки: Assessed immediately after the intervention]
• Patient's cosmetic score of the laceration immediately after repair [Срок оценки: Assessed immediately after the intervention]
• Patient's cosmetic score of the laceration scar [Срок оценки: Assessed two months after the intervention]
• Evaluator's cosmetic score of the wound assessed from a photograph [Срок оценки: Assessed two months after the intervention]

Вторичные конечные точки (3)

• Time to repair laceration [Срок оценки: Assessed immediately after the intervention]
• Laceration/scar length and width [Срок оценки: Assessed immediately after the intervention and two months after the intervention]
• Complications during and/or after the repair [Срок оценки: Assessed immediately after the intervention and two months after the intervention]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California Irvine — Orange

Идентификаторы

NCT: NCT06550999 · 4338

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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