Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management

NCT ID: NCT06362226

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& topical Maxitrol Ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periorbital Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: 5-FU/Kenalog

Group Type EXPERIMENTAL

5-FU/Kenalog

Intervention Type DRUG

Group two undergoes treatment with a subcutaneous injection of a 5-fluorouracil (5-FU) and Kenalog (triamcinolone) combination (80/20 ratio, 0.3-0.5 mL per session) administered in four sessions, spaced two weeks apart, starting within 48 hours of hospital presentation

Group B: Steroid/Antibiotic

Group Type EXPERIMENTAL

Steroid/Antibiotic (Maxitrol)

Intervention Type DRUG

Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Steroid/Antibiotic (Maxitrol)

Group one subjects receive topical maxitrol ophthalmic ointment twice daily for two weeks

Intervention Type DRUG

5-FU/Kenalog

Group two undergoes treatment with a subcutaneous injection of a 5-fluorouracil (5-FU) and Kenalog (triamcinolone) combination (80/20 ratio, 0.3-0.5 mL per session) administered in four sessions, spaced two weeks apart, starting within 48 hours of hospital presentation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Mechanism of Injury including explosion, thermal, electrical
* Clinical diagnosis of periorbital burn wound
* Second degree or less periorbital or lid bur
* No previous surgical treatment for wound management
* Partial Deep thickness Periorbital burn
* Partial Thickness Burn
* Superficial Burn
* Periocular lesions with globe involvement

Exclusion Criteria

* Recent surgical intervention for wound
* Full Thickness and or "Third degree Burns"
* Imprisoned Inmates
* Chemical Burn
* Pregnant women
* Individuals whom are not adults \>18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nikisha Richards, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nikisha Richards, MD, FACS

Role: CONTACT

804-828-8643

Terry A Henry Jr., MD

Role: CONTACT

804-638-1932

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM20029491

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Topical 0.4% Ketorolac and Vitreoretinal Surgery
NCT00576329 COMPLETED PHASE2/PHASE3
Bupivacaine Epiphora Trial
NCT03266081 WITHDRAWN PHASE2