Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Patient pain score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult (>18-years-old)
- •Small (<2.5 cm) and simple facial lacerations requiring repair
排除标准
- •Patients less than 18 years old
- •Pregnant females
- •Incarcerated individuals
研究组 & 干预措施
Adhesive strip repair
In this arm, patients will have their facial laceration properly cleaned and repaired with adhesive strips.
干预措施: Laceration repair with adhesive strips (Device)
Suture repair
In this arm, patients will have their facial laceration properly cleaned and repaired with sutures of any material.
干预措施: Laceration repair with sutures (Procedure)
结局指标
主要结局
Patient pain score
时间窗: Assessed immediately after the intervention
Visual analogue scale (VAS) - 10-cm line representing a continuum from "no pain" to "worst pain imaginable"
Patient's cosmetic score of the laceration immediately after repair
时间窗: 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)
Evaluator's cosmetic score of the wound assessed from a photograph
时间窗: 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)
Patient's cosmetic score of the laceration scar
时间窗: 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).
Patient's satisfaction and experience during laceration repair
时间窗: 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")
次要结局
- 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)
- Time to repair laceration(Assessed immediately after the intervention)
研究者
Jeffry Nahmias, MD
Health Sciences Professor
University of California, Irvine