Impact of Baumann Skin Type on Wound Healing and Scar Formation Following Facial Skin Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale version 2.0 (POSAS 2.0)
研究概览
简要总结
The goal of this observational study is to learn how an individual's skin type influences the wound healing process and scar formation in Chinese patients undergoing facial dermatologic surgery. The main questions it aims to answer are:
How does skin type affect the quality of wound healing after facial surgery?
How does skin type affect the formation of hypertrophic scars after facial surgery?
Researchers will compare groups of patients with different skin types (classified by the Baumann Skin Type) to see if there are significant differences in their healing outcomes and scar characteristics.
Participants in this study will:
Receive standard facial dermatologic surgery as part of their clinical care.
Have their skin type assessed preoperatively.
Undergo scheduled postoperative follow-up assessments at 7 and 90 days to evaluate wound healing and scar development using standardized scales.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 14 and 60 years.
- •Clinically and postoperatively pathologically diagnosed with a facial benign tumor (e.g., melanocytic nevus, sebaceous cyst, seborrheic keratosis, etc.) and having undergone standard surgical treatment.
- •Voluntary participation in this study with written informed consent obtained.
- •Commitment to comply with all study protocols and to complete all follow-up visits and data collection procedures.
排除标准
- •Clinically or postoperatively diagnosed with a facial malignant tumor.
- •Wounds requiring staged excision or planned for secondary intention healing.
- •Surgical site located on or adjacent to the mucosal surface.
- •Known history of allergy to any medications or dressings to be used during or after surgery.
- •Presence of systemic diseases that significantly impair wound healing (e.g., poorly controlled diabetes, immunodeficiency disorders, active infections).
- •Current use of medications affecting wound healing or scar formation (e.g., long-term systemic corticosteroids, immunosuppressants).
- •Pregnancy or lactation.
- •Refusal to provide written informed consent, or anticipated inability to comply with study follow-up and data collection.
- •Concurrent participation in another interventional clinical trial.
- •Any other condition deemed by the investigator as likely to interfere with study results or increase participant risk.
研究组 & 干预措施
Dry Skin
classified as having dry skin according to the Baumann questionnaire
Oily Skin
classified as having oily skin according to the Baumann questionnaire
结局指标
主要结局
Patient and Observer Scar Assessment Scale version 2.0 (POSAS 2.0)
时间窗: 3-month follow-up
This scale comprises two separate subscales: the Observer Scar Assessment Scale (completed by the clinician) and the Patient Scar Assessment Scale (completed by the participant). The Observer Scale evaluates six items (vascularity, pigmentation, thickness, relief, pliability, and surface area) on a scale from 1 ("like normal skin") to 10 ("the worst scar imaginable"), with a total score ranging from 6 (best) to 60 (worst). The Patient Scale evaluates six items (pain, itching, color, stiffness, thickness, and irregularity) on a scale from 1 ("no, not at all") to 10 ("yes, very much"), with a total score also ranging from 6 (best) to 60 (worst). For both subscales, a higher score indicates a worse scar quality.
modified Stony Brook Scar Evaluation Scale (mSBSES)
时间窗: 3-month follow-up
Evaluations were independently performed by two clinicians who were blinded to group allocation. The scale comprises four items: scar width, height, color, and suture marks. Each item is scored from 0 to 2 points, where a score of 2 represents the closest resemblance to normal skin, and 0 represents the worst appearance. The total score ranges from 0 to 8, with a higher score indicating a more ideal scar appearance.
次要结局
- Incidence of Postoperative Edema(7-day follow-up)
- Incidence of Wound Suppuration(Assessed by direct clinical examination. Unit: % of participants with the presence of suppuration.)
- Incidence of Peri-wound Ecchymosis(7-day follow-uo)
- Incidence of Peri-wound Erythema(7-day follow-up)
- Incidence of Wound Tenderness(7-day follow-up)
- Incidence of Postoperative Hemorrhage(7-day follow-up)
研究者
YangLiu82
Deputy Head of the Dermatology Department
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology