Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
This study has been terminated.
(Low patient enrollment and no clinical findings.)
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01649505
First received: July 20, 2012
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Breast Cancer Perioperative/Postoperative Complications |
Drug: fibrin sealant (Beriplast P, TISSEEL VH) Procedure: breast reconstruction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas |
Resource links provided by NLM:
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- Proportion of Patients in Each Arm Who Develop Post-operative Seromas [ Time Frame: Up to day 180 post-operation ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications [ Time Frame: Up to day 180 post-operation ] [ Designated as safety issue: No ]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.
- Quantity of Post-operative Drainage [ Time Frame: Up to day 10 post-operation ] [ Designated as safety issue: No ]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.
- Serious and Nonserious Adverse Events and Complications [ Time Frame: Up to day 180 post-operation ] [ Designated as safety issue: Yes ]
| Enrollment: | 2 |
| Study Start Date: | January 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (fibrin sealant)
Patients undergo sharp dissection technique with fibrin sealant closure.
|
Drug: fibrin sealant (Beriplast P, TISSEEL VH)
Applied topically
Other Names:
Procedure: breast reconstruction
Undergo sharp dissection technique
Other Name: Mammaplasty
|
|
Active Comparator: Arm II (standard electrocoagulation)
Patients undergo standard electrocoagulation dissection technique.
|
Procedure: breast reconstruction
Undergo electrocoagulation dissection technique
Other Name: Mammaplasty
|
Detailed Description:
PRIMARY OBJECTIVES:
I. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649505
Locations
| United States, Oregon | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Juliana Hansen | OHSU Knight Cancer Institute |
More Information
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01649505 History of Changes |
| Other Study ID Numbers: | 6606, NCI-2012-00809, P30CA069533 |
| Study First Received: | July 20, 2012 |
| Results First Received: | February 11, 2013 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Breast Neoplasms Postoperative Complications Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Pathologic Processes |
Fibrin Tissue Adhesive Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013