Comparison of Sub-Brow Versus Lateral Eyebrow Approach in Open Reduction and Internal Fixation of Frontozygomatic Fractures: A Comparative Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain, scarring, surgical field, post operative edema and time in comparison of sub brow versus lateral eyebrow approach in fixation of frontozygomatic fractures
研究概览
简要总结
INTRODUCTION :
The zygomatic complex is responsible for the mid-facial contour and for the protection of the orbital contents.
•Zygomaticomaxillary fractures, also known as tripod fractures, are usually the result of a direct blow to the body of the zygoma.
• Tripod fracture consists of (a) zygomatic arch fracture, (b) fracture of the lateral orbital wall, and (c) fracture of the inferior orbital floor.
•Fractures of the zygomatic complex are among the most frequent in maxillofacial trauma.
There are different surgical approaches mentioned in the literature for the fixation of frontozygomatic suture in zygomaticomaxillary complex fractures; such as lateral eyebrow, lateral upper blepharoplasty. However recent study has showed the use of sub brow approach for the frontozygomatic suture region. The aim of our study is to assess intra-operative and post-operative parameters such as pain, scarring, time taken to reach fractured site, surgical field(bleeding),post operative edema after fixation of frontozygomatic suture in zygomaticomaxillary complex fractures using sub brow and lateral eyebrow approach.
OBJECTIVES:
The purpose of this study is to assess intra-operative and post-operative parameters such as pain, scarring, time taken to reach fractured site, surgical field(bleeding).post operative edema after fixation of frontozygomatic suture in zygomaticomaxillary complex fractures using sub brow and lateral eyebrow approach
MATERIALS AND METHOD:
The study is a comparative study. The study sample will be derived from the population of patients with zygomaticomaxillarycomplex fractures .Fractures involving frontozygomatic suture region requiring Open Reduction and Internal Fixation who report to the Department of Oral and Maxillofacial Surgery, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Tamil Nadu, India. The patients will be randomly divided into two groups of 10 each. Randomization will be performed by lots in closed envelopes. Group I will comprise of patients treated with sub brow incision. Group II will be treated with lateral eyebrow incision.
SOURCE OF SAMPLE TO BE TAKEN:
Out patients from the department of Oral and Maxillofacial Surgery at Adhiparasakthi Dental College and Hospital
INCLUSION CRITERIA:
-
Patients who are fit for procedures under general anesthesia between age group of 16 to 50 years will be included ( ASA I and II)
-
Patients with zygomatico maxillary complex fractures involving the frontozygomatic suture
EXCLUSION CRITERIA:
1.Patients who are not willing to participate in the study
2.Patients unfit for surgery under general anesthesia ASA (III and IV)
-
Patients with zygomatico maxillary complex fractures not involving the frontozygomatic suture
-
Patients below 16 years of age.
METHODOLOGY:
The study sample will be derived from the population of patients with zygomaticomaxillarycomplex fractures. Fractures involving frontozygomatic suture requiring Open Reduction and Internal Fixation who report to the Department of Oral and Maxillofacial Surgery. Diagnosis would be made using the help of CT Facial bones. The patients will be randomly divided into two groups of 10 each. Randomization will be performed by lots in closed envelopes. Patients will be exxplained about the study and informed and a written consent will be obtained from both the patient and his/her attenders. Patients will be admitted under Oral and Maxillofacial Surgery and necessary medications would be administered. Anaesthetic fitness will be obtained. Extraoral approach will be used to expose the fracture line and an intraoral/extraoral incision will be placed if there is an additional fracture to be managed .The frontozygomatic suture region will be exposed by sub brow Group I . Group Il patients would undergo surgical site exposure by lateral eyebrow incision .Intra operative parameters includes surgical field(bleeding), measured using Fromme’s scale time taken to reach the fractured site will be evaluated.
The Fromme’s scale includes grade’s ranging from 0-5 as described below
Grade 5- Massive uncontrollable bleeding
Grade 4- Bleeding, heavy but controllable, that significantly interferes with dissection
Grade 3- Moderate bleeding that moderately compromises surgical dissection
Grade 2- Moderate bleeding, a nuisance but without interfering with accurate dissection
Grade 1- Bleeding, so mild it was not even a surgical nuisance
Grade 0 - No bleeding
. Patients will then be discharged with instructions and post operative medications and asked to report back for further assessment and evaluation pain at lst day, 7th day and 30th day
Visual Analog scale is a scale that compromises of facial emotions ranging from 0-10
0- no pain
1-3- Mild pain
4-7- moderate and severe pain
7-9- very severe pain
10- worst pain
The post operative scarring will be evaluated at 7 day, 30" day and 60" day. (Modified Vancouver scar scale)
The scale includes
Pigmentation
0 = normal
1 = hypo-pigmentation
2 = mixed pigmentation
3 = hyper-pigmentation
Vascularity
0 = normal
1 = pink
2 = red
3 = purple
Pliability
0 = normal
1 = supple-flexible with minimal resistance
2 = yielding giving way to pressure
3 = firm-inflexible, not easily moved, resistant to manual pressure
4 = banding-rope-like tissue that blanches with extension of scar
5 = contracture-permanent shortening of scar producing deformity or distortion
Height
0 = normal-flat
1 = >0 to 1 mm
2=>1 to 2 mm
3 =>2 to 4 mm
4= >4 mm
Total- 15
The post operative edema will be evaluated at 1st day, 7th day, 14th day using Facial points
The time will be measured in seconds using stopwatch
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are fit for procedures under general anesthesia between age group of 16 to 50 years will be included ( ASA I and II)
- •Patients with zygomatico maxillary complex fractures involving the frontozygomatic suture.
排除标准
- •1.Patients who are not willing to participate in the study 2.Patients unfit for surgery under general anesthesia ASA (III and IV)
- •Patients with zygomatico maxillary complex fractures not involving the frontozygomatic suture
- •Patients below 16 years of age.
结局指标
主要结局
Pain, scarring, surgical field, post operative edema and time in comparison of sub brow versus lateral eyebrow approach in fixation of frontozygomatic fractures
时间窗: Pain at 1st, 7th and 30th day, Scarring at 7th, 30th and 60th day, post operative edema at 1st, 7th and 14th day
次要结局
- surgical field and time taken(Intra operatively)
研究者
DR ANDREW FRANCIS DEVOTTA
Adhiparasakthi Dental College and Hospital
