Melanoma
Conditions
Keywords
Axillary Node Dissection, Fibrin Sealant, Tisseel, Melanoma, Seroma
Brief summary
Primary Objective: * To determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal. Secondary Objectives: * To determine the postoperative morbidity rate using fibrin sealant following axillary node dissection. * To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model. * To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.
Detailed description
Patients in this study are scheduled to have axillary node dissection as part of their surgery for treatment of their melanoma. Within 2 weeks before entry into the study, patients will have a complete physical exam and medical history. These patients will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in one group will receive TISSEEL applied externally to the dissected axillary area. Patients in the other group will receive no fibrin sealant. For patients who are admitted to the hospital, the surgical site will be monitored by the surgeon for evidence of wound complications in the first 24 hours after surgery. At the time of discharge from the hospital, patients will be instructed in drain care and how to measure the drainage each day until the drain is removed. The contents of the drain will be collected from patients during the first day after surgery, during the first return follow-up visit to M.D. Anderson Cancer Center, and during drain removal (unless these latter 2 dates are the same). Follow-up wound exams will be performed by the local primary physician or in the M.D. Anderson Melanoma Clinic between 1-4 weeks and 6 weeks after surgery. Participation will be over at the 6-week follow-up. THIS IS AN INVESTIGATIONAL STUDY. The sealant is FDA approved, though its use in this study is experimental. About 115 patients will take part in this study. All will be enrolled at M. D. Anderson.
Interventions
DRUGFibrin Sealant
Tisseel applied externally to the dissected axillary area.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Part I - Inclusion Criteria, patients that consent to participate. 2. Patients with melanoma who have undergone axillary dissection within the last six months as part of their surgical treatment will be considered for the study.
Exclusion criteria
1. Part II -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drain Duration | from surgery until drain removed, up to 40 days | Number of days drain was in place |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infection | after surgery until the wound is healed, up to 30 days whichever is longer | Number of participants with any signs of infection noted following surgery requiring intervention. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant | 47 |
| Control Arm No Intervention: No Fibrin Sealant | 45 |
| Questionnaire Only Questionnaire only | 0 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 37 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 44 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 44 Participants | 91 Participants |
| Region of Enrollment United States | 47 participants | 45 participants | 92 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 35 Participants | 37 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 45 | 0 / 0 |
| other Total, other adverse events | 0 / 47 | 0 / 45 | 0 / 0 |
| serious Total, serious adverse events | 2 / 47 | 1 / 45 | 0 / 0 |
Outcome results
Primary
Drain Duration
Number of days drain was in place
Time frame: from surgery until drain removed, up to 40 days
Population: Data not collected for Questionnaire Only Arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Drain Duration | 23 days |
| Control Arm | Drain Duration | 21 days |
Secondary
Number of Participants With Infection
Number of participants with any signs of infection noted following surgery requiring intervention.
Time frame: after surgery until the wound is healed, up to 30 days whichever is longer
Population: No data collected for Questionnaire Only Arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Number of Participants With Infection | 12 Participants |
| Control Arm | Number of Participants With Infection | 8 Participants |
| Questionnaire Only | Number of Participants With Infection | 0 Participants |