Subciliary Closure in Orbital Fracture

Not Applicable

Completed

• Conditions: Orbital Floor Fractures; Surgical Wound Closure Techniques; Subciliary Surgical Approach; Postoperative Complications in Maxillofacial Surgery

• Registration Number: NCT07042763
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

Title: Subciliary Closure in Orbital Fractures: A Comparison Between Cutaneous and Cutaneo-Periosteal Sutures

Brief Summary:

This prospective, experimental, and comparative study evaluated the impact of two different subciliary wound closure techniques in patients undergoing surgical repair of orbital floor fractures. The study was conducted at a tertiary care center in Mexico from July to October 2024 and included 100 adult patients with isolated orbital floor fractures, excluding LeFort-type fractures.

Participants were randomized into two groups: Group 1 received skin-only subciliary sutures, while Group 2 underwent closure using both cutaneous and periosteal sutures. The objective was to determine whether the addition of periosteal sutures influenced the rate of common postoperative complications, including eyelid retraction, ectropion, and the need for surgical reintervention.

Postoperative evaluations were conducted on days 8, 15, and 30. Outcomes measured included incidence of eyelid retraction, ectropion, reoperation rate, and any association with comorbidities such as smoking, diabetes, hypertension, or substance use.

The study found a statistically higher incidence of eyelid retraction in the group with combined periosteal and cutaneous closure at postoperative day 8 (16% vs. 2%, p=0.014) and day 15 (20% vs. 6%, p=0.037). However, no significant differences were noted in rates of ectropion or reintervention. Smoking, the most common comorbidity in the cohort, was not associated with a higher rate of complications.

This study suggests that skin-only closure may be preferable in subciliary orbital approaches, as it is associated with fewer cases of eyelid retraction without increasing the risk of other complications.

Detailed Description

Orbital floor fractures are among the most frequent midfacial injuries and are typically managed through surgical reconstruction via a subciliary or transconjunctival approach. Despite the frequency of these procedures, there is limited evidence evaluating the role of closure technique-specifically, whether adding periosteal sutures to cutaneous closure affects postoperative outcomes.

This study was designed to investigate whether dual-layer closure (periosteum and skin) influences the incidence of lower eyelid complications such as retraction, ectropion, and need for reoperation, compared to skin-only closure in patients treated via the subciliary approach.

Eligible participants were adults diagnosed with orbital floor fractures indicated for open surgical reduction and internal fixation. All procedures were performed by experienced surgical teams following a standardized protocol. Patients were followed for one month after surgery, and clinical outcomes were systematically assessed at three timepoints (days 8, 15, and 30 postoperatively).

The primary outcome was the presence or absence of eyelid retraction. Secondary outcomes included incidence of ectropion, need for surgical revision, and association of complications with risk factors such as smoking, diabetes, and hypertension.

This trial addresses a clinical gap by evaluating the impact of periosteal suturing in orbital trauma surgery. Findings may help guide surgeons in optimizing closure techniques to improve functional and aesthetic outcomes while minimizing postoperative complications.

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Study First Posted: 2025-06-29
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults ≥18 years of age
• Diagnosis of orbital floor fracture requiring surgical intervention
• Treatment planned through subciliary surgical approach
• Ability to attend scheduled follow-up visits at postoperative day 8, 15, and 30
• Signed informed consent obtained prior to study inclusion

Exclusion Criteria

• Fractures involving Le Fort I, II, or III patterns
• History of prior orbital surgery or trauma on the affected side
• Presence of active ocular infection or orbital cellulitis
• Uncontrolled systemic disease (e.g., decompensated diabetes, bleeding disorders)
• Pregnant or breastfeeding women
• Known non-compliance with postoperative care or follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Lower Eyelid Retraction	Postoperative Day 8, Day 15, and Day 30	The presence of clinically observable lower eyelid retraction following subciliary surgical closure will be evaluated through physical examination. Eyelid retraction is defined as the inferior displacement of the lower eyelid margin exposing the sclera.

Secondary Outcome Measures

Name	Time	Method
Incidence of Ectropion	Postoperative Day 8, Day 15, and Day 30	Ectropion will be assessed by clinical inspection, defined as outward turning of the eyelid margin resulting in loss of eyelid-globe contact.
Need for Surgical Reintervention	Within 30 days of initial surgery	Participants requiring a second surgical procedure due to complications associated with eyelid retraction, ectropion, infection, or other closure-related issues will be recorded.

Trial Locations

Locations (1)

Hospital de Especialidades del Centro Médico Nacional de Occidente (CMNO) - IMSS; 🇲🇽 Guadalajara, Jalisco, Mexico