A Randomized Controlled Trial Comparing Early to Standard Wound Dressing Removal After Facial Skin Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Edema
研究概览
简要总结
What is this study about? You are being invited to participate in a clinical research study because you are scheduled to undergo a facial skin surgery for your health condition. Your surgeon will perform your operation independently, and your standard surgical procedure and follow-up visits will not be changed in any way by this study.
The purpose of this research is to understand which postoperative care method is more beneficial for facial wound healing and for reducing scar formation. We aim to compare two common approaches for caring for the wound after surgery. Your participation will help doctors choose better care plans for future patients.
What will happen in this study?
If you agree to participate, you will be randomly assigned (like drawing lots) to one of two groups:
Group A (Early Exposure Group): About 6 hours after your surgery, the doctor will remove the sterile gauze covering your wound. After this, you will need to keep the wound area clean and dry, and you will not use a gauze dressing to cover it.
Group B (Continuous Coverage Group): After surgery, your wound will continue to be covered with sterile gauze. The doctor or nurse will change the dressing for you regularly until the sutures are removed around 7 days after surgery, or until it is decided to stop based on how the wound is healing.
What will I need to do differently?
Apart from the assigned wound care method described above, participating in this study involves only the following additions to your regular care:
Before Surgery: You will be asked to fill out a simple questionnaire about your skin and undergo a quick, non-invasive skin measurement.
During Follow-up Visits: You will be asked to fill out questionnaires and allow the study doctor to take photographs of your surgical area. These photos will be used only for analysis and record-keeping in this study.
Your total time commitment for these extra activities is minimal. Participation is entirely voluntary, and your decision will not affect the quality of your medical care.
Key Information:
Your surgeon decides your operation. This study only involves postoperative wound care.
Random Assignment: You cannot choose your group; it is decided randomly by a computer.
Privacy: Your personal information and study data (including photos) will be kept strictly confidential and used only for this research.
Potential Benefit: You may not benefit directly, but your participation will contribute to medical knowledge.
Potential Risks: The risks are considered minimal and are similar to those of standard wound care. The study doctor will monitor your healing closely.
You will receive a detailed informed consent form with more information. Please discuss any questions you have with the research team before deciding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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 18 and 60 years
- •Clinically and postoperatively pathologically diagnosed with a benign facial lesion (e.g., melanocytic nevus, sebaceous cyst, seborrheic keratosis, etc.) and having undergone standard surgical treatment
- •Voluntarily agree to participate in this study and sign a written informed consent form
- •Commit to complying with all study procedures and cooperate to complete all follow-up visits and data collection
排除标准
- •Clinically or postoperatively pathologically diagnosed with a malignant facial tumor
- •Wounds requiring staged excision or planned for secondary intention healing
- •Surgical site located on or immediately adjacent to a mucosal surface
- •Known history of allergy to surgical gauze dressings or related materials
- •Presence of systemic diseases that significantly impair wound healing (e.g., poorly controlled diabetes, immunodeficiency disorders, active infection, etc.)
- •Concurrent use of medications known to affect wound healing or scar formation (e.g., long-term use of glucocorticoids, immunosuppressants, etc.)
- •Pregnant or lactating women
- •Refusal to sign the informed consent form, or are anticipated to have difficulty complying with study follow-up and data collection
- •Concurrent participation in another interventional clinical trial
- •Any other factors deemed by the investigator as likely to interfere with the study results or increase the participant's risk
研究组 & 干预措施
Early Exposure
Six hours after surgery, the sterile gauze dressing covering the surgical area will be removed. From then on, the wound will be disinfected once daily using a 0.5% povidone-iodine solution. The wound should be kept clean and dry, with no further dressing coverage or application of other topical medications, until the sutures are removed on the seventh postoperative day.
干预措施: sterile gauze dressing (Procedure)
Continuous Coverage
On the second postoperative day, remove the initial dressing, disinfect the wound with 0.5% povidone-iodine solution (without using other topical medications), and then cover it with a sterile gauze dressing. Thereafter, repeat the dressing change every 48 hours-meaning the wound should remain continuously covered-until the sutures are removed on the seventh postoperative day.
结局指标
主要结局
Incidence of Postoperative Edema
时间窗: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of edema.
Incidence of Postoperative Wound Suppuration
时间窗: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of wound suppuration.
Incidence of Postoperative Peri-wound Erythema
时间窗: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of peri-wound erythema.
Incidence of Postoperative Wound Tenderness
时间窗: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of wound tenderness.
Incidence of Postoperative Hemorrhage
时间窗: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of postoperative hemorrhage.
Incidence of Postoperative Ecchymosis
时间窗: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of wound ecchymosis.
次要结局
- Patient and Observer Scar Assessment Scale version 2.0 (POSAS 2.0)(3-month follow-up)
- modified Stony Brook Scar Evaluation Scale (mSBSES)(3-month follow-up)
- Skindex-16(7-day follow-up)