Subciliary Closure in Orbital Fracture

NCT ID: NCT07042763

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cutaneous Suture

Subciliary incision closed with 5-0 nylon skin sutures only. No periosteal sutures were used.

Group Type: ACTIVE_COMPARATOR

Cutaneous Suture

Intervention Type: 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

Subciliary incision closed with both periosteal (4-0 Vicryl) and cutaneous (5-0 nylon) sutures.

Group Type: EXPERIMENTAL

Cutaneous Suture

Intervention Type: 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

Intervention Type: 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.

Interventions

Cutaneous Suture

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.

Intervention Type: PROCEDURE

Periosteal Suture

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: lead

Responsible Party

Clotilde Fuentes-Orozco

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Guadalajara, Jalisco, Mexico

Countries

Mexico

References

Cornelius CP, Mayer P, Ehrenfeld M, Metzger MC. The orbits--anatomical features in view of innovative surgical methods. Facial Plast Surg. 2014 Oct;30(5):487-508. doi: 10.1055/s-0034-1394303. Epub 2014 Nov 14.

Reference Type: BACKGROUND

PMID: 25397705 (View on PubMed)

Committeri U, Arena A, Carraturo E, Austoni M, Germano C, Salzano G, De Riu G, Giovacchini F, Maglitto F, Abbate V, Bonavolonta P, Califano L, Piombino P. Incidence of Orbital Side Effects in Zygomaticomaxillary Complex and Isolated Orbital Walls Fractures: A Retrospective Study in South Italy and a Brief Review of the Literature. J Clin Med. 2023 Jan 20;12(3):845. doi: 10.3390/jcm12030845.

Reference Type: BACKGROUND

PMID: 36769492 (View on PubMed)

Turvey TA, Golden BA. Orbital anatomy for the surgeon. Oral Maxillofac Surg Clin North Am. 2012 Nov;24(4):525-36. doi: 10.1016/j.coms.2012.08.003.

Reference Type: BACKGROUND

PMID: 23107426 (View on PubMed)

Other Identifiers

R-2024-1301-112.

Identifier Type: -

Identifier Source: org_study_id