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5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts
Phase 2 trial testing 5-Fluorouracil in Ectropion in 1 participant. Completed in 25 January 2019.
| Lead sponsor | Massachusetts Eye and Ear Infirmary |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 25 August 2016 |
| Primary completion | 25 January 2019 |
| Estimated completion | 25 January 2019 |
| Sites | 1 location across United States |
Massachusetts Eye and Ear Infirmary — full company profile →
Adults 18 to 89, any sex, with Ectropion or Skin Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 percent change from baseline at 12 months.
| Group | Value | 95% CI |
|---|---|---|
| 5-Fluorouracil | 10 |
Treatment side effects will be recorded. Examples include pain, skin thinning, color/texture change, atrophy, telangiectasis, infection, and erythema.
| Group | Value | 95% CI |
|---|---|---|
| 5-Fluorouracil | 0 |
Surgery complications will be recorded, not related to treatment. Examples are wound dehiscence, graft necrosis, infection, bleeding, partial/complete graft failure and/or ectropion.
| Group | Value | 95% CI |
|---|---|---|
| 5-Fluorouracil | 0 |
Patient and Observer Scar Assessment Scale (POSAS). This has 2 parts: Patient and Observer Scale. Both contain 6 items scored numerically on a 10 step scale (1 most normal, 10 worst scar imaginable). Together they sum to 'Total Score' of the Patient and Observer Scale. Category boxes are available to score nominal parameters (e.g. type of colour). Moreover, the patient and observer also score their 'Overall Opinion'. Total and subscales are averaged. \*There was 1 participant, and the score average was 1.\*
| Group | Value | 95% CI |
|---|---|---|
| 5-Fluorouracil | 1 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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