DrainagePhase 4NCT02158299
Contrast The Role of Avitene And OK-432 in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
A Phase 4 study testing Avitene, Sapylin and axillary drainage in people with Drainage and Postoperative Complications, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma formation and it can not be ignored.Investigators aimed to study two new methods of application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation and to verify the efficacy and safety of these two… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Drainage, Postoperative Complications
- What is being tested?
- Avitene, Sapylin and axillary drainage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Nov 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients volunteered for the study and signed informed consent；
- Preoperative biopsy or intraoperative sentinel lymph node biopsy confirmed axillary lymph node metastasis and need axillary lymphadenectomy
- No penicillin allergy
- No blood system diseases
- No rheumatic heart disease
- No history or family history of asthma
- No history of axillary surgery
Who cannot join
- A history of severe hypertension
- A history of diabetes
- Undergoing anticoagulant therapy or anticoagulant therapy drug withdrawal less than a year
- BMI>30
- Can not accept telephone follow-up or can not go to the hospital for subsequent inspection treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510260
Zhao Jing hua, +86-13560328074, jinghua87@163.com
Zhao Jing hua
About this study
Official title: Contrast The Role of Microfibrillar Collagen Hemostat Flour（Avitene） And OK-432 （Sapylin）in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma formation and it can not be ignored.Investigators aimed to study two new methods of application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation and to verify the efficacy and safety of these two applications.Try to prove them as beneficial supplements for axillary lymphadenectomy of breast cancer.
Read the detailed description
A prospective,randomized analysis of breast-conserving surgery or mastectomy plus axillary lymphadenectomy for those patients with sentinel node positive using Microfibrillar Collagen Hemostat Flour 、 OK-432 or using nothing in equal probability.Up to 12 months,a total of 180 will be recruited in plan.During the operation and after the axillary lymphadenectomy，according the arms，Investigators put Microfibrillar Collagen Hemostat Flour（avitene）、 OK-432（Sapylin） or nothing into patients axillary wounds。And Investigators will the statistical significance of these three arms that the postoperative drainage magnitude and duration.Also the complications associated with axillary lymphadenectomy will be studied.
- Conditions
- Drainage, Postoperative Complications
- Being tested
- Avitene, Sapylin, axillary drainage, reexamine
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AviteneDrug
SapylinDrug
axillary drainageBehavioural
reexamineOther
| Study group | Role | What they receive |
|---|---|---|
| Avitene,Drainaging,reexamine | Experimental | Not described Receives: Drug: Avitene; Behavioral: axillary drainage; Other: reexamine |
| Sapylin,Drainaging,reexamine | Experimental | Not described Receives: Drug: Sapylin; Behavioral: axillary drainage; Other: reexamine |
| Drainaging,reexamine | Active comparator | Not described Receives: Behavioral: axillary drainage; Other: reexamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative drainage magnitude
Measured: up to 1 year
Secondary outcomes (1)
Duration of the drainage
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrainageStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center
- Responsible party
- Principal investigator, Jia Weijuan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Jia Wei juan, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158299
- Sponsor's protocol ID
- Clinical trail003
- Status last verified
- Jun 2014
- First submitted
- 22 May 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast The Role of Microfibrillar Collagen Hemostat Flour（Avitene） And OK-432 （Sapylin）in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02158299
- Acronym / sponsor ID
- Clinical trail003
- Conditions
- Drainage, Postoperative Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (estimated)
- First posted
- 6 Jun 2014 (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.
After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma formation and it can not be ignored.Investigators aimed to study two new methods of application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation and to verify the efficacy and safety of these two applications.Try to prove them as beneficial supplements for axillary lymphadenectomy of breast cancer.
Detailed description
A prospective,randomized analysis of breast-conserving surgery or mastectomy plus axillary lymphadenectomy for those patients with sentinel node positive using Microfibrillar Collagen Hemostat Flour 、 OK-432 or using nothing in equal probability.Up to 12 months,a total of 180 will be recruited in plan.During the operation and after the axillary lymphadenectomy，according the arms，Investigators put Microfibrillar Collagen Hemostat Flour（avitene）、 OK-432（Sapylin） or nothing into patients axillary wounds。And Investigators will the statistical significance of these three arms that the postoperative drainage magnitude and duration.Also the complications associated with axillary lymphadenectomy will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avitene,Drainaging,reexamine | Experimental | Drug: Avitene, Behavioral: axillary drainage, Other: reexamine |
| Sapylin,Drainaging,reexamine | Experimental | Drug: Sapylin, Behavioral: axillary drainage, Other: reexamine |
| Drainaging,reexamine | Active comparator | Behavioral: axillary drainage, Other: reexamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients volunteered for the study and signed informed consent；
- Preoperative biopsy or intraoperative sentinel lymph node biopsy confirmed axillary lymph node metastasis and need axillary lymphadenectomy
- No penicillin allergy
- No blood system diseases
- No rheumatic heart disease
Key exclusion criteria (5 listed)
- A history of severe hypertension
- A history of diabetes
- Undergoing anticoagulant therapy or anticoagulant therapy drug withdrawal less than a year
- BMI>30
- Can not accept telephone follow-up or can not go to the hospital for subsequent inspection treatment
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 |
|---|---|---|
| Avitene | Drug | Avitene,Drainaging,reexamine |
| Sapylin | Drug | Sapylin,Drainaging,reexamine |
| axillary drainage | Behavioural | Avitene,Drainaging,reexamine, Drainaging,reexamine, Sapylin,Drainaging,reexamine |
| reexamine | Other | Avitene,Drainaging,reexamine, Drainaging,reexamine, Sapylin,Drainaging,reexamine |
Primary outcome
postoperative drainage magnitude
Time frame: up to 1 year
1 secondary outcome
Duration of the drainage
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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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.
Jia Wei juan principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Avitene, Sapylin and axillary drainage in people with Drainage and Postoperative Complications, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2014. 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 China. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Wei juan (+86-20-34071157, 13560328074@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative drainage magnitude (time frame: up to 1 year). 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 6 Jun 2014.