Orbital Floor FracturesNCT07042763
Subciliary Closure in Orbital Fracture
A study testing Cutaneous Suture and Periosteal Suture in people with Orbital Floor Fractures and Surgical Wound Closure Techniques, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orbital Floor Fractures, Surgical Wound Closure Techniques, Subciliary Surgical Approach
- What is being tested?
- Cutaneous Suture and Periosteal Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Especialidades del Centro Médico Nacional de Occidente (CMNO) - IMSS
Guadalajara, Jalisco
About this study
Official title: Subciliary Closure in Orbital Fracture: Comparison Between Cutaneous and Cutaneous-periosteal Suture
Title: Subciliary Closure in Orbital Fractures: A Comparison Between Cutaneous and Cutaneo-Periosteal Sutures
Brief Summary:
Read more
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.
Read the 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
- Being tested
- Cutaneous Suture, Periosteal Suture
- Keywords
- Orbital Fractures, Eyelid Diseases, Surgical Wound Dehiscence, Suture Techniques, Postoperative Complications
- Medical subject headings
- Orbital Fractures, Eyelid Diseases, Surgical Wound Dehiscence, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous SutureProcedure or surgery
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 SutureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous Suture | Active comparator | Subciliary incision closed with 5-0 nylon skin sutures only. No periosteal sutures were used. Receives: Procedure: Cutaneous Suture |
| Periosteal Suture | Experimental | Subciliary incision closed with both periosteal (4-0 Vicryl) and cutaneous (5-0 nylon) sutures. Receives: Procedure: Cutaneous Suture; Procedure: Periosteal Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 8, Day 15, and Day 30
Secondary outcomes (2)
Incidence of Ectropion
Ectropion will be assessed by clinical inspection, defined as outward turning of the eyelid margin resulting in loss of eyelid-globe contact.
Measured: Postoperative Day 8, Day 15, and Day 30
Need for Surgical Reintervention
Participants requiring a second surgical procedure due to complications associated with eyelid retraction, ectropion, infection, or other closure-related issues will be recorded.
Measured: Within 30 days of initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orbital Floor FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel, randomized, prospective surgical trial. Patients were assigned to one of two different closure techniques during orbital floor fracture repair.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Clotilde Fuentes-Orozco, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042763
- Sponsor's protocol ID
- R-2024-1301-112.
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data due to institutional restrictions and the non-pharmacologic nature of the intervention.
Publications
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.
PubMed 25397705Committeri 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.
PubMed 36769492Turvey 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.
PubMed 23107426
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subciliary Closure in Orbital Fracture: Comparison Between Cutaneous and Cutaneous-periosteal Suture
- ClinicalTrials.gov ID
- NCT07042763
- Acronym / sponsor ID
- R-2024-1301-112.
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel, randomized, prospective surgical trial. Patients were assigned to one of two different closure techniques during orbital floor fracture repair.
| Arm | Type | Receives |
|---|---|---|
| Cutaneous Suture | Active comparator | Procedure: Cutaneous SutureSubciliary incision closed with 5-0 nylon skin sutures only. No periosteal sutures were used. |
| Periosteal Suture | Experimental | Procedure: Cutaneous Suture, Procedure: Periosteal SutureSubciliary incision closed with both periosteal (4-0 Vicryl) and cutaneous (5-0 nylon) sutures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutaneous SutureSubciliary 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. | Procedure or surgery | Cutaneous Suture, Periosteal Suture |
| Periosteal SutureSubciliary 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. | Procedure or surgery | Periosteal Suture |
Primary outcome
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.
2 secondary outcomes
Incidence of Ectropion
Time frame: Postoperative Day 8, Day 15, and Day 30
Need for Surgical Reintervention
Time frame: Within 30 days of initial surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 25397705Cornelius 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.
- Background: PubMed 36769492Committeri 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.
- Background: PubMed 23107426Turvey 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.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data due to institutional restrictions and the non-pharmacologic nature of the intervention.
Related trials for Orbital Floor Fractures
Not yet recruiting
A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
Orbital Fractures, Orbital Floor Fractures
Active, not recruiting
Endoscopically Assisted Management of Maxillofacial Fractures: A Prospective Study on Efficacy and Outcomes
Maxillofacial Injuries, Maxillofacial Trauma
Enrolling by invitationObservational study
Multi-Institutional IMPACT Validation
Facial Injuries, Mandible Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutaneous Suture and Periosteal Suture in people with Orbital Floor Fractures and Surgical Wound Closure Techniques, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Lower Eyelid Retraction (time frame: Postoperative Day 8, Day 15, and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07042763, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.