Early Versus Late Intervention in Maxillofacial Trauma: A Comprehensive Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of Participants with Favorable Overall Clinical Outcome After ORIF
研究概览
简要总结
Maxillofacial trauma represents a significant clinical challenge requiring timely surgical management. This prospective study aims to compare early versus delayed intervention in patients with maxillofacial trauma and evaluate the effects of treatment timing on functional, esthetic, and radiological outcomes.
详细描述
Maxillofacial trauma is a major cause of functional impairment and facial deformity, often requiring surgical management with open reduction and internal fixation (ORIF). The timing of definitive surgical intervention remains controversial, particularly in resource-limited and conflict-affected settings where delays in treatment are common.
This prospective observational cohort study evaluates the effect of early (≤72 hours) versus delayed (>72 hours) ORIF on clinical outcomes in patients with maxillofacial fractures treated at Al-Gomhori Teaching Hospital and Military Hospital in Sana'a, Yemen.
Participants are allocated to cohorts according to the actual timing of definitive surgical treatment. The study investigates whether delayed intervention influences postoperative recovery, complication rates, functional rehabilitation, esthetic outcome, and radiographic fracture healing compared with early intervention.
Standardized surgical management and postoperative follow-up are performed according to the study protocol. Clinical and radiographic assessments are conducted during routine follow-up visits to evaluate healing and recovery over time. The findings are expected to provide evidence regarding the impact of treatment timing on outcomes of maxillofacial trauma and to support clinical decision-making in similar healthcare settings.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12 years and older.
- •Patients diagnosed with maxillofacial fractures requiring open reduction and internal fixation (ORIF).
- •Patients presenting with maxillofacial trauma treated within the participating study centers.
- •Patients assigned to either the early intervention group (≤72 hours after injury) or the delayed intervention group (>72 hours after injury).
- •Patients able to provide written informed consent or whose legally authorized representative provides consent when applicable.
- •Patients willing to comply with the scheduled follow-up visits. years and older.
排除标准
- •Patients managed with conservative (non-surgical) treatment.
- •Patients with previous maxillofacial fractures affecting the study site.
- •Patients with incomplete baseline clinical data.
- •Patients with severe medical conditions precluding surgical treatment or follow-up.
- •Patients lost to follow-up before completion of the primary outcome assessment.
- •Patients who decline to participate or withdraw informed consent.
研究组 & 干预措施
Early Intervention Group
Patients who underwent open reduction and internal fixation (ORIF) within 72 hours after maxillofacial trauma. This cohort includes patients receiving early surgical intervention following injury, according to the predefined study protocol.
干预措施: Timing of Open Reduction and Internal Fixation (ORIF) (Procedure)
Delayed Intervention Group
Patients who underwent open reduction and internal fixation (ORIF) more than 72 hours after maxillofacial trauma. This cohort includes patients receiving delayed surgical intervention due to factors such as delayed presentation, associated injuries, logistical limitations, or other clinical considerations.
干预措施: Timing of Open Reduction and Internal Fixation (ORIF) (Procedure)
结局指标
主要结局
Percentage of Participants with Favorable Overall Clinical Outcome After ORIF
时间窗: 6 months after surgery
A favorable overall clinical outcome will be assessed using the study's standardized follow-up case sheet and clinical examination. The assessment includes wound healing, postoperative infection, fixation stability, functional recovery (maximum mouth opening, occlusion, mastication, temporomandibular joint function), neurological status, esthetic outcome (facial symmetry and scar appearance), and radiographic bone healing. Results will be reported as the percentage of participants achieving a favorable overall clinical outcome.
次要结局
- Radiological Bone Healing(1, 3, and 6 months after surgery)
- Percentage of Participants with Satisfactory Functional Recovery Based on Clinical Examination(48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery)
- Percentage of Participants with Satisfactory Esthetic Outcome(1 month, 3 months, and 6 months after surgery)
- Incidence of Intraoperative Complications During ORIF(During surgery)
- Incidence of Postoperative Complications Following ORIF(48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery)
研究者
Haifa Mohammed Sharaf-Aldeen
PhD Candidate in Oral and Maxillofacial Surgery, Faculty of Dentistry, Sana'a University
Sana'a University