Breast CancerNCT01649505
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
A study testing fibrin sealant (Beriplast P, TISSEEL VH) and breast reconstruction in people with Breast Cancer and Perioperative/Postoperative Complications, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Perioperative/Postoperative Complications
- What is being tested?
- fibrin sealant (Beriplast P, TISSEEL VH) and breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will be undergoing latissimus dorsi donor flap harvest reconstruction and evaluated by the Department of Plastic and Reconstructive Surgery at Oregon Health and Science University (OHSU)
- These patients will be undergoing reconstructive surgery for a mastectomy/wide local excision of breast cancer defect or other soft tissue defect resulting from trauma, infection, undesirable surgical outcome, oncologic resection, etc.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who will not qualify for latissimus dorsi donor flap reconstruction based on anatomical limitations specific the subjects respectively; to be evaluated by the plastic surgeon
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fibrin glue sealant
- Patients with evidence of hematological disorders resulting in deficient coagulation whereby sharp dissection would result in undesirable bleeding otherwise performed more safely with electrosurgery
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate differing surgical techniques (sharp dissection v. electrosurgical, use of fibrin glue) in latissimus dorsi donor flap harvest and their effect, if any on the prevention of post-operative seromas.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo sharp dissection technique with fibrin sealant closure.
ARM II: Patients undergo standard electrocoagulation dissection technique.
After completion of study treatment, patients are followed up for 90-180 days.
- Being tested
- fibrin sealant (Beriplast P, TISSEEL VH), breast reconstruction
- Medical subject headings
- Breast Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrin sealant (Beriplast P, TISSEEL VH)Drug
Also called Beriplast P, TISSEEL VH
Applied topically
breast reconstructionProcedure or surgery
Also called Mammaplasty
Undergo sharp dissection technique
breast reconstructionProcedure or surgery
Also called Mammaplasty
Undergo electrocoagulation dissection technique
| Study group | Role | What they receive |
|---|---|---|
| Arm I (fibrin sealant) | Experimental | Patients undergo sharp dissection technique with fibrin sealant closure. Receives: Drug: fibrin sealant (Beriplast P, TISSEEL VH); Procedure: breast reconstruction |
| Arm II (standard electrocoagulation) | Active comparator | Patients undergo standard electrocoagulation dissection technique. Receives: Procedure: breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients in Each Arm Who Develop Post-operative Seromas
Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.
Measured: Up to day 180 post-operation
Secondary outcomes (3)
Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications
Computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed.
Measured: Up to day 180 post-operation
Quantity of Post-operative Drainage
Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.
Measured: Up to day 10 post-operation
Serious and Nonserious Adverse Events and Complications
Measured: Up to day 180 post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Low patient enrollment and no clinical findings.
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Juliana Hansen, OHSU Knight Cancer Institute
- Investigators
- Juliana Hansen, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649505
- Sponsor's protocol ID
- IRB00006606
- Other IDs
- NCI-2012-00809
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2012
- Last updated
- 2 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
- ClinicalTrials.gov ID
- NCT01649505
- Acronym / sponsor ID
- IRB00006606
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient enrollment and no clinical findings.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Posted 15 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin
Detailed description
PRIMARY OBJECTIVES:
- To evaluate differing surgical techniques (sharp dissection v. electrosurgical, use of fibrin glue) in latissimus dorsi donor flap harvest and their effect, if any on the prevention of post-operative seromas.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo sharp dissection technique with fibrin sealant closure.
ARM II: Patients undergo standard electrocoagulation dissection technique.
After completion of study treatment, patients are followed up for 90-180 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (fibrin sealant) | Experimental | Drug: fibrin sealant (Beriplast P, TISSEEL VH), Procedure: breast reconstructionPatients undergo sharp dissection technique with fibrin sealant closure. |
| Arm II (standard electrocoagulation) | Active comparator | Procedure: breast reconstructionPatients undergo standard electrocoagulation dissection technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will be undergoing latissimus dorsi donor flap harvest reconstruction and evaluated by the Department of Plastic and Reconstructive Surgery at Oregon Health and Science University (OHSU)
- These patients will be undergoing reconstructive surgery for a mastectomy/wide local excision of breast cancer defect or other soft tissue defect resulting from trauma, infection, undesirable surgical outcome, oncologic resection, etc.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (3 listed)
- Patients who will not qualify for latissimus dorsi donor flap reconstruction based on anatomical limitations specific the subjects respectively; to be evaluated by the plastic surgeon
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fibrin glue sealant
- Patients with evidence of hematological disorders resulting in deficient coagulation whereby sharp dissection would result in undesirable bleeding otherwise performed more safely with electrosurgery
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 sealant (Beriplast P, TISSEEL VH)Also: Beriplast P, TISSEEL VHApplied topically | Drug | Arm I (fibrin sealant) |
| breast reconstructionAlso: MammaplastyUndergo sharp dissection technique | Procedure or surgery | Arm I (fibrin sealant) |
| breast reconstructionAlso: MammaplastyUndergo electrocoagulation dissection technique | Procedure or surgery | Arm II (standard electrocoagulation) |
Primary outcome
Proportion of Patients in Each Arm Who Develop Post-operative Seromas
Time frame: Up to day 180 post-operation
Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.
3 secondary outcomes
Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications
Time frame: Up to day 180 post-operation
Quantity of Post-operative Drainage
Time frame: Up to day 10 post-operation
Serious and Nonserious Adverse Events and Complications
Time frame: Up to day 180 post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Juliana Hansen principal investigator
OHSU Knight Cancer Institute
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 (Beriplast P, TISSEEL VH) and breast reconstruction in people with Breast Cancer and Perioperative/Postoperative Complications, run by OHSU Knight Cancer Institute 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Nov 2022. 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 15 Mar 2013). 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?
Proportion of Patients in Each Arm Who Develop Post-operative Seromas (time frame: Up to day 180 post-operation). 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 2 Nov 2022.