A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma
18 Years
N/A
Both
Melanoma
Trial Information
A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma
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.
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 - Exclusion Criteria, patients with known hypersensitivity to bovine
proteins.
2. Patient has undergone prior radiation therapy to the operative site.
3. Patient is pregnant or lactating.
4. Patient is steroid dependent within prior 6 months.
5. Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within
seven days of operation.
6. Patient has pre-existing lymphedema.
7. Patient has other pre-existing medical conditions with evidence of organ dysfunction
as determined by principal investigator.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Use of TISSEEL (adhesive substance) to decrease the rate of seroma (fluid build-up) at the site of surgery, thus decreasing the time it takes before the drain can be removed.
Outcome Time Frame:
8 Years
Safety Issue:
No
Principal Investigator
Paul F. Mansfield, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
GS01-565
NCT ID:
NCT00504582
Start Date:
May 2002
Completion Date:
Related Keywords:
- Melanoma
- Axillary Node Dissection
- Fibrin Sealant
- Tisseel
- Melanoma
- Seroma
- Melanoma
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
