5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts
Condition: Ectropion; Skin Neoplasms
MeSH terms: Skin Neoplasms; Ectropion
Intervention: 5-Fluorouracil; Normal saline
Intervention description: Treatment medication; Placebo
Intervention MeSH terms: Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Skin graft; 5-Fluorouracil; Periocular reconstruction

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients

          -  Ages 18 to 89 years of age

          -  Has a condition (e.g. trauma, skin/tissue defect, scar) requiring a skin graft for
             repair

          -  Sufficient education to understand study procedures and to give consent

        Exclusion Criteria:

          -  Women lactating, pregnant or planning to get pregnant in the near future

          -  Immunosuppression/immunocompromise or serious/active infections

          -  Dihydropyrimidine dehydrogenase enzyme deficiency

          -  Severe hepatic or renal impairment or failure

          -  Unable to give consent or understand the study