Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- outcomes
研究概览
简要总结
The overall objective of this study is to evaluate the safety of using the galea and pericranium (fascio-periosteal) temporal flap in the reconstruction of mandibular gingival defects.
详细描述
Reconstruction with free flaps is a routine practice in head and neck surgery because of better functional, aesthetic results and generally higher success rates.
Current applications of this practice include reconstructive surgeries that follow excisions of neoplastic lesions involving the oral cavity. Following resection of the primary tumor, reconstructive surgery is usually necessary in order to restore function to the oral cavity.
The most appropriate reconstructive method is determined by several factors, including the characteristics of the defects and primary tumor site, the general medical condition, the patient's social history, the prognosis, and the surgeon's expertise. Reconstructive methods usually follow a "reconstructive ladder," starting with a skin graft and ending with a microvascular free flap.
Free tissue transfers are currently one of the most popular and reliable techniques for oral reconstruction.
The use of periosteal flaps for reconstruction of bone defects has been described by several authors. In particular, a well-known technique by Bettoni et al. [5] demonstrated excellent results, also in terms of bone regeneration, following the use of free periosteum flaps taken from radius in the treatment of osteoradionecrosis of mandible.
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
- •Patients aged ≥18 years;
- •Patients with mandibular gingival defects involving the anterior or lateral aspect of the mandible;
- •Patients in whom basal structural integrity of the mandibular bone is maintained;
- •Patients with a minimum follow-up of 3 months;
- •Obtaining informed consent.
排除标准
- •Patients with history of previous surgery that bilaterally altered the superficial temporal vasculature.
研究组 & 干预措施
patient
The study will involve patients referred to the Department of Maxillofacial Surgery, IRCCS Azienda Ospedaliero-Universitaria di Bologna who require simple reconstruction following parcellar resections of the mandibular gingival region. It is planned to recruit during the above period 5 patients who meet the following inclusion and exclusion criteria.
干预措施: Reconstruction following parcellar resections of the mandibular gingival region (Procedure)
结局指标
主要结局
outcomes
时间窗: 18 months
Number and % of patients with adequate flap viability, defined as effective vascular supply and complete rooting of the flap at the recipient site, without tissue necrosis. Partial viability will be considered as incomplete rooting of the flap with associated peripheral tissue necrosis affecting less than 1/3 of the surface de
次要结局
未报告次要终点