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5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02705352
Recruitment Status : Terminated (Low enrollment)
First Posted : March 10, 2016
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
Michael Yoon, Massachusetts Eye and Ear Infirmary

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 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.

Condition or disease Intervention/treatment Phase
Ectropion Skin Neoplasms Drug: 5-Fluorouracil Other: Normal saline Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blinded Comparison of the Use of 5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts.
Actual Study Start Date : August 25, 2016
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 5-Fluorouracil
Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.
Drug: 5-Fluorouracil
Treatment medication
Other Name: 5-FU

Placebo Comparator: Normal saline
Normal saline will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.
Other: Normal saline
Other Name: Saline

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02705352

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United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
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Principal Investigator: Michael K Yoon, MD Massachusetts Eye and Ear Infirmary

Publications of Results:

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Responsible Party: Michael Yoon, Ophthalmic Plastic and Reconstructive Surgery Attending, Massachusetts Eye and Ear Infirmary Identifier: NCT02705352     History of Changes
Other Study ID Numbers: 786680-1
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael Yoon, Massachusetts Eye and Ear Infirmary:
Skin graft
Periocular reconstruction
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Skin Diseases
Eyelid Diseases
Eye Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs