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.|
|ClinicalTrials.gov Identifier: NCT02705352|
Recruitment Status : Terminated (Low enrollment)
First Posted : March 10, 2016
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ectropion Skin Neoplasms||Drug: 5-Fluorouracil Other: Normal saline||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02705352
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Michael K Yoon, MD||Massachusetts Eye and Ear Infirmary|