Breast Cancer, Perioperative/Postoperative Complications
Conditions
Brief 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. 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: 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.
Interventions
DRUGfibrin sealant (Beriplast P, TISSEEL VH)
Applied topically
PROCEDUREbreast reconstruction
Undergo sharp dissection technique
Sponsors
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in Each Arm Who Develop Post-operative Seromas | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications | Up to day 180 post-operation | 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 | Up to day 10 post-operation | 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 | Up to day 180 post-operation | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Fibrin Sealant) Patients undergo sharp dissection technique with fibrin sealant closure.
breast reconstruction : Undergo sharp dissection technique
fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically | 1 |
| Arm II (Standard Electrocoagulation) Patients undergo standard electrocoagulation dissection technique.
breast reconstruction : Undergo electrocoagulation dissection technique | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Arm II (Standard Electrocoagulation) | Arm I (Fibrin Sealant) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 44 years | 44 years | 44 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
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.
Time frame: Up to day 180 post-operation
Population: Data was not collected due to early termination and very low accrual
Secondary
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.
Time frame: Up to day 180 post-operation
Population: Data was not collected due to early termination and very low accrual
Secondary
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.
Time frame: Up to day 10 post-operation
Population: Data was not collected due to early termination and very low accrual
Secondary
Serious and Nonserious Adverse Events and Complications
Time frame: Up to day 180 post-operation
Population: Data was not collected due to early termination and very low accrual