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Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

Primary Purpose

Zygomatic Fractures

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Y modification of transconjunctival approach
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zygomatic Fractures

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Patients with ZMC fractures that requires open reduction with internal fixation.
  • Adult patient between 20 and 50 years with no gender predilections.

Exclusion criteria

  • Existing lacerations in the inferior and lateral periorbital regions.
  • Comminuted fracture with bone loss.
  • Existence of infection at the fracture line.
  • Presence of Acute and chronic conjunctival diseases.

Sites / Locations

  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transconjunctival Y modification

Arm Description

Outcomes

Primary Outcome Measures

The exposure duration
The time taken between performing the incision till exposure of the field
postoperative edema
the postoperative edema was categorized subjectively into mild (just noticeable), mild to moderate (more obvious edema without occlusion of palpebral fissure), moderate to severe (edema partially occluding palpebral fissure), and severe (edema totally occluding palpebral fissure).
change in postoperative pain
assessed through a 10-point Visual Analogue Scale (VAS),(34) (0-1=none,2-4=mild,5-7=moderate,8-10=severe).

Secondary Outcome Measures

Full Information

First Posted
January 17, 2021
Last Updated
January 20, 2021
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04719312
Brief Title
Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
Official Title
Evaluation of Modification of the Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex. Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion. Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zygomatic Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transconjunctival Y modification
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Y modification of transconjunctival approach
Intervention Description
Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor. Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region. The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach. A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished.
Primary Outcome Measure Information:
Title
The exposure duration
Description
The time taken between performing the incision till exposure of the field
Time Frame
at the surgery
Title
postoperative edema
Description
the postoperative edema was categorized subjectively into mild (just noticeable), mild to moderate (more obvious edema without occlusion of palpebral fissure), moderate to severe (edema partially occluding palpebral fissure), and severe (edema totally occluding palpebral fissure).
Time Frame
after 1 week
Title
change in postoperative pain
Description
assessed through a 10-point Visual Analogue Scale (VAS),(34) (0-1=none,2-4=mild,5-7=moderate,8-10=severe).
Time Frame
24 hours, 48 hours, 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients with ZMC fractures that requires open reduction with internal fixation. Adult patient between 20 and 50 years with no gender predilections. Exclusion criteria Existing lacerations in the inferior and lateral periorbital regions. Comminuted fracture with bone loss. Existence of infection at the fracture line. Presence of Acute and chronic conjunctival diseases.
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
State/Province
Azarita
ZIP/Postal Code
00203
Country
Egypt

12. IPD Sharing Statement

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Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

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