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NCT Number: NCT07759440

Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair

Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton. Precise repair of the ZMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure, and an accurate rigid fixation of fracture to restore the normal form. The aesthetic results are one of the most important requirements for these incisions in facial fracture reduction. Conventional approaches to the infraorbital rim/orbital floor include transcutaneous as subciliary, subtarsal and infraorbital incisions and transconjunctival incision. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications.

Aim of this study:To compare between transconjunctival approach and transcutaneous approaches in open reduction of zygomaticomaxillary fracture.

Materials and methods: A study will be made on 75 patients who will undergo fracture repair of the zygomaticomaxillary complex. Twenty five of them (group A) will be treated via a subtarsal approach while. Other Twenty five patients (group B) via a transconjunctival approach. The remaining Twenty five patients (Group C) will be treated via infraorbital appeoach. Postoperative patient evaluation will be performed with specific attention paid towards, accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance ,postoperative pain, postoperative edema , wound healing, scaring, infection and postoperative ocular complications such as ectropion, entropion, scleral show and corneal abrasion. Postoperatively clinical examination along with radiographic examination will be done to evaluate the position of the zygoma and determine the adequacy of fracture reduction.

Results: will be statistically analyzed using the IBM Statistical Package for Social Science (SPSS) software version 22.0

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria university

Alexandria, Outside US and Canada, 2881055, Egypt

Location status: Recruiting

Location contact

Mona Oraby

CONTACT

[email protected]

01000775330

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient with orbital fractures (e.g., orbital floor or zygomaticomaxillary complex fractures) require 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 or chronic conjunctival diseases.

Treatment and study plan

orbital fracture reduction and fixation

Other

orbital fracture reduction and fixation

Primary outcomes

  1. operation time

    Time frame: intraopertive in minutes

    starting from the skin incision till the reduction and fixation of the orbital rim

  2. accessibility

    Time frame: intraopertive

    objective assessment by the main surgeon ( mild, moderate, excellent) accessibility

Secondary outcomes

  1. wound healing 1

    Time frame: 1, 2 and 8 weeks

    by Manchester scar scale

Study contacts

Contact information is provided by the study sponsor or research team.

Mona s Oraby, PHd

CONTACT

[email protected]

+201000775330

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair : ( Randomized Clinical Trial)

Acronym: Vs: versus

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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