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NCT Number: NCT07042763

Subciliary Closure in Orbital Fracture

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.

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Key information

Conditions

Orbital Floor Fractures Craniocerebral Trauma Eye Diseases Eyelid Diseases Facial Injuries Fractures, Bone Maxillofacial Injuries Nervous System Diseases Orbital Fractures Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Complications in Maxillofacial Surgery Skull Fractures Subciliary Surgical Approach Surgical Wound Closure Techniques Surgical Wound Dehiscence Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Especialidades del Centro Médico Nacional de Occidente (CMNO) - IMSS

Guadalajara, Jalisco, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cutaneous Suture

Procedure

Subciliary incision followed by closure using skin sutures only. The skin was closed with 5-0 nylon using subdermal interrupted sutures. No closure of the periosteal plane was performed.

Periosteal Suture

Procedure

Subciliary incision followed by closure of both the periosteum and skin layers. The periosteum was closed with absorbable 4-0 Vicryl sutures, and the skin was closed with 5-0 nylon using subdermal sutures.

Primary outcomes

  1. Incidence of Lower Eyelid Retraction

    Time frame: 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 outcomes

  1. Incidence of Ectropion

    Time frame: 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.

  2. Need for Surgical Reintervention

    Time frame: 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.

Other outcomes

  1. Correlation Between Smoking Status and Eyelid Retraction

    Time frame: From enrollment to postoperative day 30

    This outcome assesses whether active smoking is associated with an increased incidence of lower eyelid retraction following subciliary surgical closure. Eyelid retraction will be evaluated by physical examination and defined as the inferior displacement of the eyelid margin exposing the sclera.

  2. Correlation Between Smoking Status and Ectropion

    Time frame: From enrollment to postoperative day 30

    This outcome evaluates whether active smoking correlates with the incidence of ectropion after orbital fracture repair. Ectropion is defined as outward turning of the eyelid margin with loss of eyelid-globe contact, assessed by clinical inspection.

  3. Correlation Between Smoking Status and Need for Surgical Reintervention

    Time frame: From enrollment to 30 days after initial surgery

    This outcome assesses whether active smoking increases the need for a secondary surgical procedure due to complications such as eyelid retraction, ectropion, or wound-related problems.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Subciliary Closure in Orbital Fracture: Comparison Between Cutaneous and Cutaneous-periosteal Suture

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2025
Registry last updated
Jul 4, 2025

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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