Clinical Trial: 5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Prospective, Randomized, Double-blinded Comparison of the Use of 5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts.

Brief 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

Detailed Summary:

In oculofacial surgery, full thickness skin grafts are a fundamental tool used to restore function to the eyelid. This can be required after removal of skin cancer, correction of eyelid malposition such as cicatricial eyelid ectropion (the eyelid edge is pulled away from the eye), retraction (the eyelid is pulled lower than normal, exposing more of the eye to the air), scar formation (such as a medial pulling or web), or trauma with loss of tissue. These conditions affect patients of all ages, ranging from newborns to nonagenarians. Skin grafting in the periorbital area is relatively safe, although complications may arise. The most common and challenging complication scarring and graft shrinkage. This can lead to requiring additional surgery to add additional skin or to improve the appearance of the graft. In addition to the morbidity of another surgery, some patients have limited or no additional skin available (e.g. young patients, burn patients). The eyelid skin is the thinnest of the body, so only thin skin can be used as donor material. However, the amount of skin available for this purpose is very little.

There are limited options for preventing graft shrinkage and scarring in this situation. The oldest and most commonly used technique is injection of steroid medication. Steroids decrease proliferation of a fibroblast cells, which create collagen and glycosaminoglycan, two proteins created by the body that contract and cause graft shrinkage. Data in literature shows that one form of steroid, triamcinolone, is effective for this purpose. However, there is a risk of embolization of this solid steroid material that care rarely cause blindness. In addition, in the periocular area, steroids can elevate eye (intraocular) pressure (that can cause glaucoma in some cases) and accelerate the formation of cataracts.

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Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome: Graft change [ Time Frame: 12 months ]

Full thickness skin grafts will be measured prior to treatment (at time of surgery) and 12 months after surgery. Although the graft will be measured at each visit, the outcome is the final size at 12 months.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events [ Time Frame: 12 months ]
    Treatment side effects will be recorded. Examples include pain, skin thinning, color/texture change, atrophy, telangiectasis, infection, and erythema.
  • Early post-operative complications [ Time Frame: 2 weeks after surgery ]
    Surgery complications will be recorded, not related to treatment. Examples are wound dehiscence, graft necrosis, infection, bleeding, partial/complete graft failure and/or ectropion.
  • Surgeon and Patient satisfaction [ Time Frame: 12 months ]
    Surgeon and patient satisfaction will be evaluated using a scar assessment scale (POSAS) at each visit. Questionnaire developed and previously published by Draaijers et al 2004.


Original Secondary Outcome: Same as current

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: February 22, 2016
Date Started: October 2016
Date Completion: October 2018
Last Updated: September 12, 2016
Last Verified: September 2016