Intraoperative Use of Fibrin Glue Sealant Combined With Sharp Dissection Technique as a Preventative Measure for Seromas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Proportion of Patients in Each Arm Who Develop Post-operative Seromas
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (fibrin sealant)
Patients undergo sharp dissection technique with fibrin sealant closure.
干预措施: fibrin sealant (Beriplast P, TISSEEL VH) (Drug)
Arm I (fibrin sealant)
Patients undergo sharp dissection technique with fibrin sealant closure.
干预措施: breast reconstruction (Procedure)
Arm II (standard electrocoagulation)
Patients undergo standard electrocoagulation dissection technique.
干预措施: breast reconstruction (Procedure)
结局指标
主要结局
Proportion of Patients in Each Arm Who Develop Post-operative Seromas
时间窗: 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.
次要结局
- Quantity of Post-operative Drainage(Up to day 10 post-operation)
- Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications(Up to day 180 post-operation)
- Serious and Nonserious Adverse Events and Complications(Up to day 180 post-operation)
研究者
Juliana Hansen
Principal Investigator
OHSU Knight Cancer Institute