Trial Outcomes & Findings for Fibrin Melanoma Axillary Node Study in Patients With Melanoma (NCT NCT00504582)
NCT ID: NCT00504582
Last Updated: 2023-05-09
Results Overview
Number of days drain was in place
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
from surgery until drain removed, up to 40 days
Results posted on
2023-05-09
Participant Flow
All patients with the diagnosis of melanoma undergoing axillary node dissection were screened for eligibility. If they met the eligibility criteria, were offered the study. The primary outcome is to determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal.
There were 121 total patients associated with this study. 92 patients were evaluable for the treatment study. 9 patients were inevaluable due to withdrew consent, surgery cancelled, patient elected to proceed with biopsy not surgery, not coming to MD Anderson, diagnosed with merkle cell carcinoma and sarcoma. There were 20 patients with melanoma who have undergone axillary dissection within prior six months as part of their surgical treatment who only completed the questionnaire.
Participant milestones
| Measure |
Treatment Arm
Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
|
Control Arm
No Intervention: No Fibrin Sealant
|
Questionnaire Only
Questionnaire only
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
20
|
|
Overall Study
COMPLETED
|
46
|
45
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Arm
Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
|
Control Arm
No Intervention: No Fibrin Sealant
|
Questionnaire Only
Questionnaire only
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Fibrin Melanoma Axillary Node Study in Patients With Melanoma
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=47 Participants
Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
|
Control Arm
n=45 Participants
No Intervention: No Fibrin Sealant
|
Questionnaire Only
Questionnaire only
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
—
|
73 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
—
|
19 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
—
|
20 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
—
|
72 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
—
|
90 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
—
|
91 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=99 Participants
|
45 participants
n=107 Participants
|
—
|
92 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: from surgery until drain removed, up to 40 daysPopulation: Data not collected for Questionnaire Only Arm.
Number of days drain was in place
Outcome measures
| Measure |
Treatment Arm
n=44 Participants
Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
|
Control Arm
n=45 Participants
No Intervention: No Fibrin Sealant
|
Questionnaire Only
Questionnaire Only
|
|---|---|---|---|
|
Drain Duration
|
23 days
Interval 7.0 to 40.0
|
21 days
Interval 5.0 to 36.0
|
—
|
SECONDARY outcome
Timeframe: after surgery until the wound is healed, up to 30 days whichever is longerPopulation: No data collected for Questionnaire Only Arm.
Number of participants with any signs of infection noted following surgery requiring intervention.
Outcome measures
| Measure |
Treatment Arm
n=46 Participants
Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
|
Control Arm
n=45 Participants
No Intervention: No Fibrin Sealant
|
Questionnaire Only
Questionnaire Only
|
|---|---|---|---|
|
Number of Participants With Infection
|
12 Participants
|
8 Participants
|
0 Participants
|
Adverse Events
Treatment Arm
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Questionnaire Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=47 participants at risk
Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant
|
Control Arm
n=45 participants at risk
No Intervention: No Fibrin Sealant
|
Questionnaire Only
Questionnaire Only
|
|---|---|---|---|
|
Infections and infestations
Infection
|
4.3%
2/47 • After surgery until the wound is healed or thirty days whichever is longer.
No data collected for the Questionnaire Only Arm, therefore no adverse events to report for the Questionnaire Only Arm.
|
2.2%
1/45 • After surgery until the wound is healed or thirty days whichever is longer.
No data collected for the Questionnaire Only Arm, therefore no adverse events to report for the Questionnaire Only Arm.
|
—
0/0 • After surgery until the wound is healed or thirty days whichever is longer.
No data collected for the Questionnaire Only Arm, therefore no adverse events to report for the Questionnaire Only Arm.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paul F Mansfield, Professor, Surgical Oncology
UT MD Anderson Cancer Center
Phone: (713) 794-5499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place