5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts
Status:
Completed
Trial end date:
2019-01-25
Target enrollment:
Participant gender:
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 as
indicated. The study medication or placebo (normal saline) will be administered 2-3 weeks
after surgery and then every 2-3 weeks afterwards for up to a total of 4 injections. After
the injections, regular scheduled follow-up will be at 3, 6, and 12 months post-op. Outcomes
at each study visit (up to 12 months post-operatively) include graft size, color, contour,
and complications between study treatment group and placebo group.