MelanomaNCT00504582
Fibrin Melanoma Axillary Node Study in Patients With Melanoma
A study testing Fibrin Sealant in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Fibrin Sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2002to 9 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part I - Inclusion Criteria, patients that consent to participate.
- 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.
Who cannot join
- Part II - Exclusion Criteria, patients with known hypersensitivity to bovine proteins.
- Patient has undergone prior radiation therapy to the operative site.
- Patient is pregnant or lactating.
- Patient is steroid dependent within prior 6 months.
- Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
- Patient has pre-existing lymphedema.
- Patient has other pre-existing medical conditions with evidence of organ dysfunction as determined by principal investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma
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.
Read more
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- Fibrin Sealant
- Keywords
- Axillary Node Dissection, Fibrin Sealant, Tisseel, Melanoma, Seroma
- Medical subject headings
- Melanoma, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin SealantDrug
Also called Tisseel
Tisseel applied externally to the dissected axillary area.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Sealant | Experimental | Tisseel applied externally to the dissected axillary area. Receives: Drug: Fibrin Sealant |
| No Fibrin Sealant | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain Duration
Number of days drain was in place
Measured: from surgery until drain removed, up to 40 days
Secondary outcomes (1)
Number of Participants With Infection
Number of participants with any signs of infection noted following surgery requiring intervention.
Measured: after surgery until the wound is healed, up to 30 days whichever is longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study start15 May 2002
- Primary completion9 Apr 2020
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul F. Mansfield, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504582
- Sponsor's protocol ID
- GS01-565
- Other IDs
- NCI-2012-01524
- Status last verified
- Apr 2023
- First submitted
- 19 Jul 2007
- Last updated
- 9 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Axillary Node Dissection in Patients With Melanoma
- ClinicalTrials.gov ID
- NCT00504582
- Acronym / sponsor ID
- GS01-565
- Conditions
- Melanoma
- Keywords
- Axillary Node Dissection, Fibrin Sealant, Tisseel, Melanoma, Seroma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 15 May 2002 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Posted 26 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Sealant | Experimental | Drug: Fibrin SealantTisseel applied externally to the dissected axillary area. |
| No Fibrin Sealant | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Part I - Inclusion Criteria, patients that consent to participate.
- 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.
Key exclusion criteria (7 listed)
- Part II - Exclusion Criteria, patients with known hypersensitivity to bovine proteins.
- Patient has undergone prior radiation therapy to the operative site.
- Patient is pregnant or lactating.
- Patient is steroid dependent within prior 6 months.
- Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin SealantAlso: TisseelTisseel applied externally to the dissected axillary area. | Drug | Fibrin Sealant |
Primary outcome
Drain Duration
Time frame: from surgery until drain removed, up to 40 days
Number of days drain was in place
1 secondary outcome
Number of Participants With Infection
Time frame: after surgery until the wound is healed, up to 30 days whichever is longer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Melanoma
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A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
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RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F. Mansfield, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibrin Sealant in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drain Duration (time frame: from surgery until drain removed, up to 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.