Subciliary Closure in Orbital Fracture

NCT07042763 | Completed

• 1 other identifier: R-2024-1301-112.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Orbital Fractures; Eyelid Diseases; Surgical Wound Dehiscence; Suture Techniques; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of Lower Eyelid Retraction

  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.

  Postoperative Day 8, Day 15, and Day 30

Secondary Outcomes (2)

• Incidence of Ectropion

  Postoperative Day 8, Day 15, and Day 30

• Need for Surgical Reintervention

  Within 30 days of initial surgery

Other Outcomes (3)

• Correlation Between Smoking Status and Eyelid Retraction

  From enrollment to postoperative day 30

• Correlation Between Smoking Status and Ectropion

  From enrollment to postoperative day 30

• Correlation Between Smoking Status and Need for Surgical Reintervention

  From enrollment to 30 days after initial surgery

Study Arms (2)

Cutaneous Suture

ACTIVE COMPARATOR

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

Procedure: Cutaneous Suture

Periosteal Suture

EXPERIMENTAL

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

Procedure: Cutaneous Suture; Procedure: Periosteal Suture

Interventions

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.

Cutaneous Suture; Periosteal Suture

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.

Periosteal Suture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

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

Guadalajara, Jalisco, Mexico

Location

Related Publications (3)

• 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.

  PMID: 25397705 BACKGROUND

• 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.

  PMID: 36769492 BACKGROUND

• 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.

  PMID: 23107426 BACKGROUND

MeSH Terms

Conditions

Orbital Fractures; Eyelid Diseases; Surgical Wound Dehiscence; Postoperative Complications

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. The surgical technique was visible to both care providers and patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two-arm, parallel, randomized, prospective surgical trial. Patients were assigned to one of two different closure techniques during orbital floor fracture repair.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)