Fibrin Melanoma Axillary Node Study in Patients With Melanoma

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00504582
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Arms: 2
• Actual Duration (Months): 215.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: Fibrin Sealant	N/A

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.

1. Anderson.

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma
• Actual Study Start Date: May 1, 2002
• Actual Primary Completion Date: Apr 9, 2020
• Actual Study Completion Date: Apr 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fibrin Sealant Tisseel applied externally to the dissected axillary area.	Drug: Fibrin Sealant; Tisseel applied externally to the dissected axillary area.; Other Names: Tisseel
No Intervention: No Fibrin Sealant

Outcome Measures

Primary Outcome Measures

1. Drain Duration [from surgery until drain removed, up to 40 days]

   Number of days drain was in place

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 - 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Paul F. Mansfield, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 29, 2008

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00504582
• Other Study ID Numbers: GS01-565; NCI-2012-01524
• First Posted: Jul 20, 2007
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Keywords provided by M.D. Anderson Cancer Center: Axillary Node Dissection; Fibrin Sealant; Tisseel; Melanoma; Seroma
• Additional relevant MeSH terms: Melanoma; Fibrin Tissue Adhesive

Study Results

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 Detail

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.

Arm/Group Title	Treatment Arm	Control Arm	Questionnaire Only
Arm/Group Description	Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant	No Intervention: No Fibrin Sealant	Questionnaire only
Period Title: Overall Study
STARTED	47	45	20
COMPLETED	46	45	20
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	Treatment Arm	Control Arm	Questionnaire Only	Total
Arm/Group Description	Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant	No Intervention: No Fibrin Sealant	Questionnaire only	Total of all reporting groups
Overall Participants	47	45	0	92
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 NaN
Between 18 and 65 years	36 76.6%	37 82.2%	73 Infinity
>=65 years	11 23.4%	8 17.8%	19 Infinity
Sex: Female, Male (Count of Participants)
Female	12 25.5%	8 17.8%	20 Infinity
Male	35 74.5%	37 82.2%	72 Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.1%	1 2.2%	2 Infinity
Not Hispanic or Latino	46 97.9%	44 97.8%	90 Infinity
Unknown or Not Reported	0 0%	0 0%	0 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 NaN
Asian	0 0%	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 NaN
Black or African American	0 0%	1 2.2%	1 Infinity
White	47 100%	44 97.8%	91 Infinity
More than one race	0 0%	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	47 100%	45 100%	92 Infinity

Outcome Measures

1. Primary Outcome

Title	Drain Duration
Description	Number of days drain was in place
Time Frame	from surgery until drain removed, up to 40 days

Outcome Measure Data

Analysis Population Description

Data not collected for Questionnaire Only Arm.

Arm/Group Title	Treatment Arm	Control Arm	Questionnaire Only
Arm/Group Description	Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant	No Intervention: No Fibrin Sealant	Questionnaire Only
Measure Participants	44	45	0
Mean (Full Range) [days]	23	21

2. Secondary Outcome

Title	Number of Participants With Infection
Description	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

Outcome Measure Data

Analysis Population Description

No data collected for Questionnaire Only Arm.

Arm/Group Title	Treatment Arm	Control Arm	Questionnaire Only
Arm/Group Description	Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant	No Intervention: No Fibrin Sealant	Questionnaire Only
Measure Participants	46	45	0
Count of Participants [Participants]	12 25.5%	8 17.8%	0 NaN

Adverse Events

Time Frame	After surgery until the wound is healed or thirty days whichever is longer.
Adverse Event Reporting Description	No data collected for the Questionnaire Only Arm, therefore no adverse events to report for the Questionnaire Only Arm.
Arm/Group Title	Treatment Arm		Control Arm		Questionnaire Only
Arm/Group Description	Tisseel applied externally to the dissected axillary area. Intervention: Drug: Fibrin Sealant		No Intervention: No Fibrin Sealant		Questionnaire Only
All Cause Mortality
	Treatment Arm		Control Arm		Questionnaire Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/45 (0%)		0/0 (NaN)
Serious Adverse Events
	Treatment Arm		Control Arm		Questionnaire Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/47 (4.3%)		1/45 (2.2%)		0/0 (NaN)
Infections and infestations
Infection	2/47 (4.3%)		1/45 (2.2%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Treatment Arm		Control Arm		Questionnaire Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/45 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.