SeromaPhase 4NCT00852826
Evaluation of a Hemostatic and Sealing Agent to Prevent Surgical Complications After Axillary Lymphadenectomy
A Phase 4 study testing Standard axillary lymphadenectomy and Collagen sponge coated with human coagulation factors in people with Seroma, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
This study was intended to assess the value of a hemostatic and sealing agent, a collagen sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for decreasing occurrence of seroma after axillary lymphadenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seroma
- What is being tested?
- Standard axillary lymphadenectomy and Collagen sponge coated with human coagulation factors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Nov 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients with axillary lymphadenectomies performed for oncological conditions.
Who cannot join
- Patients that did not want to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario "Virgen de la Arrixaca"
Murcia, Murcia, 30120
About this study
Official title: Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy
This study was intended to assess the value of a hemostatic and sealing agent, a collagen sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for decreasing occurrence of seroma after axillary lymphadenectomy.
- Conditions
- Seroma
- Being tested
- Standard axillary lymphadenectomy, Collagen sponge coated with human coagulation factors
- Keywords
- axillary seroma, axillary lymphadenectomy, morbidity, morbidity postlymphadenectomy, Lymphadenectomy
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard axillary lymphadenectomyProcedure or surgery
Standard axillary lymphadenectomy
Collagen sponge coated with human coagulation factorsProcedure or surgery
Also called TachoSil(R), Nycomed Pharma, AS.
Three patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Standard axillary lymphadenectomy Receives: Procedure: Standard axillary lymphadenectomy |
| 2 | Experimental | Three patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls Receives: Procedure: Collagen sponge coated with human coagulation factors |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startJan 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Investigators
- Antonio Piñero, MD PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852826
- Sponsor's protocol ID
- LFN001/08
- Status last verified
- Feb 2009
- First submitted
- 26 Feb 2009
- Last updated
- 27 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of a Hemostatic and Sealing Agent for Preventing Seroma After Axillary Lymphadenectomy
- ClinicalTrials.gov ID
- NCT00852826
- Acronym / sponsor ID
- LFN001/08
- Conditions
- Seroma
- Keywords
- axillary seroma, axillary lymphadenectomy, morbidity, morbidity postlymphadenectomy, Lymphadenectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Jan 2008
- Study completion
- Nov 2008
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was intended to assess the value of a hemostatic and sealing agent, a collagen sponge coated with human coagulation factors (fibrinogen and thrombin) (TachoSil®), for decreasing occurrence of seroma after axillary lymphadenectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Procedure: Standard axillary lymphadenectomyStandard axillary lymphadenectomy |
| 2 | Experimental | Procedure: Collagen sponge coated with human coagulation factorsThree patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with axillary lymphadenectomies performed for oncological conditions.
Key exclusion criteria (1 listed)
- Patients that did not want to participate in the study.
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 |
|---|---|---|
| Standard axillary lymphadenectomyStandard axillary lymphadenectomy | Procedure or surgery | 1 |
| Collagen sponge coated with human coagulation factorsAlso: TachoSil(R), Nycomed Pharma, AS.Three patches of collagen sponge coated with human coagulation factors (TachoSil®, Nycomed Pharma, AS) were perpendicularly placed at the end of lymphadenectomy on the axillary neurovascular bundle, thoracodorsal pedicle, and costal wall, covering the axillary walls | Procedure or surgery | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2009.
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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.
Antonio Piñero, MD PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard axillary lymphadenectomy and Collagen sponge coated with human coagulation factors in people with Seroma, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 1 inclusion and 1 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 27 Feb 2009. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 27 Feb 2009.