跳至主要内容
临床试验/CTRI/2025/02/079893
CTRI/2025/02/079893尚未招募Phase 3 4

Comparison of Sub-Brow Versus Lateral Eyebrow Approach in Open Reduction and Internal Fixation of Frontozygomatic Fractures: A Comparative Study

DR ANDREW FRANCIS DEVOTTA1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月17日最近更新:

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:

  1. Patients who are fit for procedures under general anesthesia between age group of 16 to 50 years will be included ( ASA I and II)

  2. 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)

  1. Patients with zygomatico maxillary complex fractures not involving the frontozygomatic suture

  2. 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

发起方
DR ANDREW FRANCIS DEVOTTA
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

DR ANDREW FRANCIS DEVOTTA

Adhiparasakthi Dental College and Hospital

研究点 (1)

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