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NCT02705352 · ClinicalTrials.gov registry record · Phase 2
5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts
A Phase 2 study, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02705352 is a Phase 2 study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 1 participants.
The verdict
NCT02705352, a Phase 2 study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Full thickness skin grafts are an essential tool in surgery around the eyelids for reconstruction or rehabilitation following injury or surgery. Common conditions where skin grafts are needed include cicatricial ectropion, restoration of eyelid function after tumor removal, burns to the eyelids, or trauma. Early complications, occurring in the first 2 weeks after surgery, are rare: wound dehiscence, necrosis, infection, bleeding, partial or complete graft failure. However, late postoperative complications generally categorized as "scarring" (including graft hypertrophy and contraction, keloid formation, and hypo/hyper pigmentation) can limit the success and acceptability of the procedure by patients. Scars form following any insult to the deep dermis as a result of wound healing. Factors such as age, skin type, racial pigmentation, genetics, and sex may influence fibroblast proliferation as part of the healing response, resulting in a suboptimal result. Graft contraction is perhaps the most worrisome result, since it can result in failure of the initial surgery and may require additional surgery to correct. Many treatments have been used to manage these complications: corticosteroid injection, cryotherapy, pressure therapy, radiotherapy, laser therapy, silicone based products, and antimetabolite therapy. One such antimetabolite, 5-fluorouracil (5-FU), has been used over the last 15 years as an adjunct or primary treatment to modulate wound healing and scar formation. Other studies have demonstrated safety for cutaneous and subcutaneous injection in the periocular region. However, no controlled studies exist. This prospective, randomized, and double-blinded clinical study will evaluate the use and benefit of 5-FU versus saline in patients undergoing skin grafting for periocular reconstruction. The decision for the need for skin grafting will be at the discretion of the attending surgeon and will be made separate from enrollment in the study. Surgery will be performed
Interventions
- DRUG 5-Fluorouracil
- OTHER Normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-08-25 |
| Est. Completion | 2019-01-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02705352
The ClinicalTrials.gov registry entry for NCT02705352 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 5-Fluorouracil is the first listed.
NCT02705352 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02705352 about?
NCT02705352 is a clinical study titled "5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts". Full thickness skin grafts are an essential tool in surgery around the eyelids for reconstruction or rehabilitation following injury or surgery. Common conditions where skin grafts are needed include cicatricial ectropion, restoration of eyelid function after tumor removal, burns to the eyelids, or ...
What is the current status of trial NCT02705352?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2016-08-25. Estimated completion is 2019-01-25.
What interventions are being tested in trial NCT02705352?
The interventions under investigation include: 5-Fluorouracil (DRUG), Normal saline (OTHER).
Who is sponsoring clinical trial NCT02705352?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
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