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Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07759440
Acronym
Vs: versus
Enrollment
75
Registered
2026-08-12
Start date
2026-05-25
Completion date
2026-11-25
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orbital Fractures

Brief summary

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

Interventions

OTHERorbital fracture reduction and fixation

orbital fracture reduction and fixation

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
operation timeintraopertive in minutesstarting from the skin incision till the reduction and fixation of the orbital rim
accessibilityintraopertiveobjective assessment by the main surgeon ( mild, moderate, excellent) accessibility

Secondary

MeasureTime frameDescription
wound healing 11, 2 and 8 weeksby Manchester scar scale

Countries

Egypt

Contacts

CONTACTMona s Oraby, PHd
mona.oraby@alexu.edu.eg+201000775330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026