Trial Outcomes & Findings for 5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts (NCT NCT02705352)
NCT ID: NCT02705352
Last Updated: 2020-03-09
Results Overview
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.
COMPLETED
PHASE2
1 participants
12 months
2020-03-09
Participant Flow
Challenges recruiting patients into the study.
Participant milestones
| Measure |
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.
5-Fluorouracil: Treatment medication
|
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.
Normal saline: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
5-fluorouracil Versus Placebo in Periocular Full Thickness Skin Grafts
Baseline characteristics by cohort
| Measure |
5-Fluorouracil
n=1 Participants
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.
5-Fluorouracil: Treatment medication
|
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.
Normal saline: Placebo
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Scar appearance
|
1 units on a scale
n=39 Participants
|
—
|
1 units on a scale
n=35 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
—
|
1 Participants
n=35 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 0 • n=39 Participants
|
—
|
72 years
STANDARD_DEVIATION 0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
—
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
—
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
—
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=39 Participants
|
—
|
1 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: One white male in study group
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.
Outcome measures
| Measure |
5-Fluorouracil
n=1 Participants
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.
5-Fluorouracil: Treatment medication
|
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.
Normal saline: Placebo
|
|---|---|---|
|
Graft Size Change
|
10 percent change in graft
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Unable to recruit more study patients.
Treatment side effects will be recorded. Examples include pain, skin thinning, color/texture change, atrophy, telangiectasis, infection, and erythema.
Outcome measures
| Measure |
5-Fluorouracil
n=1 Participants
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.
5-Fluorouracil: Treatment medication
|
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.
Normal saline: Placebo
|
|---|---|---|
|
Adverse Events
|
0 Events
|
—
|
SECONDARY outcome
Timeframe: 2 weeks after surgeryPopulation: Unable to recruit more study patients.
Surgery complications will be recorded, not related to treatment. Examples are wound dehiscence, graft necrosis, infection, bleeding, partial/complete graft failure and/or ectropion.
Outcome measures
| Measure |
5-Fluorouracil
n=1 Participants
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.
5-Fluorouracil: Treatment medication
|
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.
Normal saline: Placebo
|
|---|---|---|
|
Early Post-operative Complications
|
0 Number of events
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Unable to recruit more patients.
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.\*
Outcome measures
| Measure |
5-Fluorouracil
n=1 Participants
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.
5-Fluorouracil: Treatment medication
|
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.
Normal saline: Placebo
|
|---|---|---|
|
Surgeon and Patient Satisfaction
|
1 score on a scale
|
—
|
Adverse Events
5-Fluorouracil
Normal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place