Serial Dermabrasion for Aesthetic Enhancement of Free Flap Skin Paddles and Donor Sites: A Prospective Split-Flap/Scar Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Aesthetic grading of treated area compared to untreated
研究概览
简要总结
The purpose of this study is to evaluate the aesthetic benefit and safety of serial dermabrasion for free flap skin paddles and donor site scars in head and neck reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •History of successful free flap reconstruction with a cutaneous skin paddle in the head and neck region.
- •Patients with benign (eg. osteoradionecrosis, trauma) or malignant (eg. squamous cell carcinoma) diagnoses requiring free flap reconstruction.
- •Benign free flap patients must be a minimum 3 months post-operative to ensure flap maturity. Malignant free flap patients must be a minimum of 3 months post-operative or post-radiation with no further cancer treatment (eg. radiation, surgery, chemotherapy) planned at that time.
- •Flap skin paddle must be of sufficient size and external to allow for split-treatment design (minimum 4 cm in diameter). Donor site scar must also be sufficient size (minimum 6 cm in length)
- •Patients must have ability to provide informed consent.
- •Willingness and ability to comply with the treatment and follow-up schedule.
排除标准
- •Inability to give informed consent.
- •Evidence of active flap or radiation skin complications (e.g., infection, partial necrosis, wound breakdown).
- •Completion of head and neck radiation therapy within 3 months of first dermabrasion treatment date.
- •Uncontrolled diabetes mellitus (HbA1c > 8.0%).
- •Current antibiotic use or known immunocompromised state.
- •History of keloid formation or hypertrophic scarring.
- •Fitzpatrick skin type VI or higher (due to increased risk of pigmentary changes).
- •Use of isotretinoin medication within the past 3 month (known to induce photosensitivity).
- •Current use of blood thinners that cannot be safely paused.
- •Known photosensitivity disorders.
- •Active malignancy requiring ongoing treatment.
- •Inability or unwillingness to avoid sun exposure during the treatment period.
- •Inability to perform or adhere to prescribed wound care.
- •Inability or unwillingness to attend follow-up visits.
结局指标
主要结局
Aesthetic grading of treated area compared to untreated
时间窗: 1, 3, and 6 months post-treatment
Aesthetic improvement of the treated half of the free flap skin paddle/donor site scar, as compared to the untreated half. This will be measured through blinded evaluations of standardized clinical photographs. Each side of the skin paddle or donor site scar will be labeled as side 1 or 2.
Aesthetic grading of treated area compared to untreated
时间窗: 1, 3, and 6 months post-treatment
Aesthetic improvement of the treated half of the free flap skin paddle/donor site scar, as compared to the untreated half. This will be measured through blinded evaluations of standardized clinical photographs. Each side of the skin paddle or donor site scar will be labeled as side 1 or 2.
次要结局
未报告次要终点
研究者
Jessyka Lighthall
Chief, Facial Plastic and Reconstructive Surgery, Professor, Department of Otolaryngology-Head and Neck Surgery
Milton S. Hershey Medical Center