Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Development and Clinical Validation of an Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Follicular unit extraction (FUE) is a widely used surgical technique for hair restoration, yet hair follicle survival rates vary depending on surgical instrumentation, graft handling, and perioperative care.
The purpose of this clinical trial is to evaluate whether an evidence-based, integrated perioperative protocol maximizes hair follicle graft survival compared with standard departmental practice in male patients undergoing FUE for androgenetic alopecia or localized scarring alopecia.
Participants will be randomly assigned to one of two groups:
- Integrated Protocol Group: Patients receive FUE surgery guided by a standardized workflow featuring algorithmic punch selection (0.8-1.0 mm), pre-set extraction depth and angulation, chilled holding solutions maintained at 4 °C, strict graft out-of-body time limits (target ≤2-4 hours), and standardized recipient site implantation.
- Standard FUE Practice Group: Patients receive FUE surgery according to routine departmental practice, where punch selection, harvesting parameters, and graft handling follow the operating surgeon's standard routine.
Follicle survival and hair density will be tracked using digital trichoscopy in pre-marked 1×1 cm reference scalp areas over a 12-month follow-up period. Investigators will also assess intraoperative follicular transection rates, procedural complications, and patient satisfaction between the two groups.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male patients aged 18 to 60 years.
- Clinically diagnosed androgenetic alopecia (Norwood-Hamilton grade II-V) or localized scarring alopecia suitable for follicular unit extraction (FUE).
- Adequate donor area hair density (≥ 40 FU/cm²) confirmed by trichoscopic evaluation.
- Minimal or no response to at least 6 months of medical treatment (e.g., topical minoxidil, oral finasteride), where applicable.
- General good health with no contraindications to minor outpatient surgery under local anesthesia.
- Willingness and ability to provide written informed consent and comply with the full 12-month follow-up schedule.
Exclusion Criteria:
- Active scalp infection, dermatitis, or other active dermatological disease at the donor or recipient site.
- History or tendency of keloid or hypertrophic scarring.
- Bleeding diathesis or current use of anticoagulant/antiplatelet therapy that cannot be safely discontinued.
- Uncontrolled systemic disease (e.g., uncontrolled diabetes mellitus, cardiovascular, hepatic, renal, or pulmonary disease).
- Immunosuppression or current use of immunosuppressive medication.
- Endocrine disorders directly causing hair loss (e.g., uncontrolled thyroid disease) or active telogen effluvium.
- Psychiatric illness affecting the capacity to provide informed consent or comply with follow-up, or unrealistic patient expectations.
- Previous hair transplantation in the same donor or recipient area within the preceding 12 months.
- Known hypersensitivity to local anesthetics used in the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Integrated Protocol Group
Participants undergo follicular unit extraction (FUE) using a standardized, evidence-based perioperative workflow. This includes algorithmic punch selection (0.8-1.0 mm) based on donor hair caliber and scalp characteristics, pre-set extraction depth (2.5-4 mm) and natural exit angulation, atraumatic microsurgical forceps handling, chilled holding solution maintained at 4 °C, strict time-stamping with graft out-of-body time targeted to ≤2-4 hours, and standardized recipient site implantation density (30-50 FU/cm²). |
A standardized perioperative FUE protocol consisting of: algorithmic micromotor punch selection (0.8-1.0 mm diameter; sharp, blunt, or serrated/trumpet-shaped) based on hair caliber, curl, and scalp laxity; pre-set extraction depth (2.5-4.0 mm) aligned with natural hair exit angles; atraumatic graft extraction using Foerster-type microsurgical forceps; graft preservation in a chilled holding solution maintained at 4 °C; strict monitoring targeting total out-of-body time to ≤2-4 hours; and standardized recipient site creation and implantation (30-50 FU/cm²) via micro-blades or Choi-type implanter pens. |
|
Активный компаратор: Standard FUE Practice Group
Participants undergo follicular unit extraction (FUE) according to routine departmental practice, where punch selection, harvesting depth, extraction angle, and graft handling/storage procedures are performed according to the operating surgeon's standard, non-standardized routine. All perioperative medications and post-operative care instructions remain identical to the experimental arm. |
Conventional follicular unit extraction performed according to routine departmental practice, wherein extraction punch selection, harvesting depth, incision angles, graft holding conditions, and out-of-body handling times are determined based on the operating surgeon's individual routine without standardized protocolized constraints. Postoperative care and medical regimens remain identical to the experimental arm. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Hair Follicle Survival Rate
Временное ограничение: 12 months postoperatively
|
Hair follicle graft survival rate assessed within the pre-marked 1×1 cm recipient study reference boxes using digital trichoscopy. The survival percentage is calculated using the following formula: [(Number of follicles counted at 12 months - baseline follicle count in recipient area) ÷ (Number of grafts transplanted into the reference box)] × 100%. |
12 months postoperatively
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FUE Follicle Survival Protocol
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .