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A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma


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Trial Information

A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma


Patients in this study are scheduled to have groin 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 groin 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.

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 after the 6-week follow-up.

This is an investigational study. The sealant is FDA approved, though its use in this study
is experimental. About 58 patients will take part in this study. All will be enrolled at M.
D. Anderson.


Inclusion Criteria:



- Part I - Inclusion Criteria Patients that consent to participate.

- Patients with melanoma who have undergone superficial node dissection (with or
without a concurrent deep (ilioinguinal) node dissection within the last six months
as part of their surgical treatment will be considered for the study.

- Part II- Inclusion Criteria Patients that consent to participate.

- Patients with melanoma for which a superficial node dissection is indicated (with or
without a concurrent deep (ilioinguinal) node dissection.

Exclusion Criteria:

- Part II - Exclusion Criteria Patients with known hypersensitivity to bovine proteins.

- Patient has undergone prior radiation therapy to the operative site (groin).

- Patient is pregnant or lactating.

- Patient is steroid dependent within last 6 months.

- Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within
seven days of operation.

- Patients with pre-existing lymphedema.

- Patients with other pre-existing medical conditions as per the discretion of the
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:

Time-to-Drain Removal

Outcome Description:

The superficial groin drain will be removed once cumulative serous drainage volume 30 ml / 24 hours for 2 days or maximum of = or < 30 days has elapsed since surgery. Time calculated as days from installation of drain at first day of surgery to removal.

Outcome Time Frame:

From surgery to 30 days post surgery

Safety Issue:

No

Principal Investigator

Janice N. Cormier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

GS01-564

NCT ID:

NCT00506311

Start Date:

February 2003

Completion Date:

March 2008

Related Keywords:

  • Melanoma
  • Superficial Groin Dissection
  • Melanoma
  • Fibrin Tissue Adhesive
  • Fibrin Sealant
  • Tisseel
  • Seroma
  • Melanoma

Name

Location

U.T.M.D. Anderson Cancer Center Houston, Texas  77030