Breast CancerMRMNCT00909649
Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy
A study testing fibrin glue in breast surgery in people with Breast Cancer, run by Mansoura University at 2 sites in Egypt.
Trial summary
This study was carried out from January 2005 to December 2007 at Mansoura university hospital. Fifty patients who had breast cancer were included in the study, MRM was done for all patients. Patients were randomly divided into two groups. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- fibrin glue in breast surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2005to Jun 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with operable breast cancer
Who cannot join
- Patients who received preoperative chemotherapy and radiotherapy were exclude
- Patients with previous axillary surgery
- Patients who underwent simultaneous reconstructive surgery and breast conservative surgery
- Locally advanced breast cancer
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ayman Elnakeeb
Al Mansurah, Mansoura, 050
Ayman Elnakeeb
Mansoura , Egypt, Mansoura,egypt, 050
About this study
Official title: Influence of Fibrin Glue on Seroma Formation After Modified Radical
This study was carried out from January 2005 to December 2007 at Mansoura university hospital. Fifty patients who had breast cancer were included in the study, MRM was done for all patients. Patients were randomly divided into two groups. Group І with fibrin glue 4ml of fibrin glue was sprayed on the surgical area with Y canula and group П without fibrin glue. Preoperative, Operative and Postoperative data were collected including postoperative measurement of drainage, date of removal of the drain, state of the wound, incidence of Seroma formation.
Read the detailed description
This study was carried out from January 2005 to December 2007 at Mansoura university hospital, Departement 8 of surgical department. This study approved by local ethical committee Fifty patients had breast cancer were included in the study. Patients who received preoperative chemotherapy and radiotherapy were exclude Also, patients with previous axillary surgery or patients who underwent simultaneous reconstructive surgery and breast conservative surgery and locally advanced breast cancer were exclude.
Informed written consent was obtained from all patients included in the study. All patients include in the study, MRM was done for then and axillary lymphadenectomy extended to the axillary level III was done with sharp dissection and ligation of the visible lymph vessels and minor blood vessel. After performing hemostasis in the mastectomy and axillary area. .Patients were randomly divided by closed envelop into two groups. Patients were randomized at end of surgical procedure to avoid possible treatment bias during surgical procedure.
Group І (with fibrin glue) and group П without fibrin glue. In fibrin glue group. 4 ml of fibrin glue was sprayed on the surgical area with Y canula (doubleject application system). In group 11 after good haemostasis the same sized drain was applied in axillary and breast area and incision was closed. Followed by external compression for 10 minutes in both groups. Drains were left in places until the drainage for the preceding 24 h was less than 30 ml/day.
Data collected Preoperative data collected included age, body mass indexed (BMI), medical and surgical history, history of chemotherapy, radiotherapy Operative data included estimated blood loss, types of dissection, duration of the operation Postoperative data included hospital stay , postoperative measurement of drainage daily , date of removal , state of the wound ( infection , haematoma, necrosis , opened wound ), number of axillary lymph nodes dissected , cancer stage , number of axillary lymph nodes positive, incidence of Seroma formation , interval of Seroma resolution , Seroma aspirated volume and number of postoperative visits Seroma formation was defined as inability to remove participant drain by postoperative day 10 because of high output (more than 30 ml /day drain Seroma) and / or the need to aspirate of fluid after removal of the drain.
- Conditions
- Breast Cancer
- Being tested
- fibrin glue in breast surgery
- Keywords
- fibrin glue, seroma, mastectomy
- Medical subject headings
- Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrin glue in breast surgeryProcedure or surgery
Also called fibrin glue after modifed radical mastectomy
fibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group
| Study group | Role | What they receive |
|---|---|---|
| 1 fibrin glue | Active comparator | 8 ml of fibrin glue was sprayed on the surgical area with Y canula ( doubleject application system).One milliliter of fibrin glue contains 70-100 mg. fibrinogen, 10-50 u factor 8 aprotinin 3000k iu/ml, 2-9 mg fibronectin,40-120 ug plasminogen ,4 Iu/ml thrombin, 40 mmol cocl2/L (immuno AG/austrial) Receives: Procedure: fibrin glue in breast surgery |
| 2 non fibrin glue | No intervention | after good haemostasis the same sized drain was applied in axillary and breast area and incision was closed. Followed by external compression for 10 minutes in both groups. Drains were left in places until the drainage for the preceding 24 h was less than 20 ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma Formation
the mean total drainage volume
Measured: within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionJun 2007
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- ayman elnakeeb, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909649
- Sponsor's protocol ID
- seroma in breast surgery
- Acronym
- MRM
- Status last verified
- Apr 2009
- First submitted
- 5 Dec 2008
- Last updated
- 28 May 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ulusoy AN, Polat C, Alvur M, Kandemir B, Bulut F. Effect of fibrin glue on lymphatic drainage and on drain removal time after modified radical mastectomy: a prospective randomized study. Breast J. 2003 Sep-Oct;9(5):393-6. doi: 10.1046/j.1524-4741.2003.09506.x.
PubMed 12968960Johnson L, Cusick TE, Helmer SD, Osland JS. Influence of fibrin glue on seroma formation after breast surgery. Am J Surg. 2005 Mar;189(3):319-23. doi: 10.1016/j.amjsurg.2005.01.004.
PubMed 15792759
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fibrin Glue on Seroma Formation After Modified Radical
- ClinicalTrials.gov ID
- NCT00909649
- Acronym / sponsor ID
- MRM / seroma in breast surgery
- Conditions
- Breast Cancer
- Keywords
- fibrin glue, seroma, mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 28 May 2009 (estimated)
- Results
- Posted 28 May 2009
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 carried out from January 2005 to December 2007 at Mansoura university hospital. Fifty patients who had breast cancer were included in the study, MRM was done for all patients. Patients were randomly divided into two groups. Group І with fibrin glue 4ml of fibrin glue was sprayed on the surgical area with Y canula and group П without fibrin glue. Preoperative, Operative and Postoperative data were collected including postoperative measurement of drainage, date of removal of the drain, state of the wound, incidence of Seroma formation.
Detailed description
This study was carried out from January 2005 to December 2007 at Mansoura university hospital, Departement 8 of surgical department. This study approved by local ethical committee Fifty patients had breast cancer were included in the study. Patients who received preoperative chemotherapy and radiotherapy were exclude Also, patients with previous axillary surgery or patients who underwent simultaneous reconstructive surgery and breast conservative surgery and locally advanced breast cancer were exclude.
Informed written consent was obtained from all patients included in the study. All patients include in the study, MRM was done for then and axillary lymphadenectomy extended to the axillary level III was done with sharp dissection and ligation of the visible lymph vessels and minor blood vessel. After performing hemostasis in the mastectomy and axillary area. .Patients were randomly divided by closed envelop into two groups. Patients were randomized at end of surgical procedure to avoid possible treatment bias during surgical procedure.
Group І (with fibrin glue) and group П without fibrin glue. In fibrin glue group. 4 ml of fibrin glue was sprayed on the surgical area with Y canula (doubleject application system). In group 11 after good haemostasis the same sized drain was applied in axillary and breast area and incision was closed. Followed by external compression for 10 minutes in both groups. Drains were left in places until the drainage for the preceding 24 h was less than 30 ml/day.
Data collected Preoperative data collected included age, body mass indexed (BMI), medical and surgical history, history of chemotherapy, radiotherapy Operative data included estimated blood loss, types of dissection, duration of the operation Postoperative data included hospital stay , postoperative measurement of drainage daily , date of removal , state of the wound ( infection , haematoma, necrosis , opened wound ), number of axillary lymph nodes dissected , cancer stage , number of axillary lymph nodes positive, incidence of Seroma formation , interval of Seroma resolution , Seroma aspirated volume and number of postoperative visits Seroma formation was defined as inability to remove participant drain by postoperative day 10 because of high output (more than 30 ml /day drain Seroma) and / or the need to aspirate of fluid after removal of the drain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 fibrin glue | Active comparator | Procedure: fibrin glue in breast surgery8 ml of fibrin glue was sprayed on the surgical area with Y canula ( doubleject application system).One milliliter of fibrin glue contains 70-100 mg. fibrinogen, 10-50 u factor 8 aprotinin 3000k iu/ml, 2-9 mg fibronectin,40-120 ug plasminogen ,4 Iu/ml thrombin, 40 mmol cocl2/L (immuno AG/austrial) |
| 2 non fibrin glue | No intervention | –after good haemostasis the same sized drain was applied in axillary and breast area and incision was closed. Followed by external compression for 10 minutes in both groups. Drains were left in places until the drainage for the preceding 24 h was less than 20 ml. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with operable breast cancer
Key exclusion criteria (4 listed)
- Patients who received preoperative chemotherapy and radiotherapy were exclude
- Patients with previous axillary surgery
- Patients who underwent simultaneous reconstructive surgery and breast conservative surgery
- Locally advanced breast cancer
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 glue in breast surgeryAlso: fibrin glue after modifed radical mastectomyfibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group | Procedure or surgery | 1 fibrin glue |
Primary outcome
Seroma Formation
Time frame: within 30 days postoperative
the mean total drainage volume
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12968960Ulusoy AN, Polat C, Alvur M, Kandemir B, Bulut F. Effect of fibrin glue on lymphatic drainage and on drain removal time after modified radical mastectomy: a prospective randomized study. Breast J. 2003 Sep-Oct;9(5):393-6. doi: 10.1046/j.1524-4741.2003.09506.x.
- Results publication: PubMed 15792759Johnson L, Cusick TE, Helmer SD, Osland JS. Influence of fibrin glue on seroma formation after breast surgery. Am J Surg. 2005 Mar;189(3):319-23. doi: 10.1016/j.amjsurg.2005.01.004.
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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.
ayman elnakeeb principal investigator
Mansoura University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fibrin glue in breast surgery in people with Breast Cancer, run by Mansoura University at 2 sites in Egypt.
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 4 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 28 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 28 May 2009). 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?
Seroma Formation (time frame: within 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00909649, which also lists 2 linked publications.
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 28 May 2009.