Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Post-op Complications
研究概览
简要总结
To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.
详细描述
After being informed of the study including potential risks and benefits, all patients giving consent who meet eligibility requirements will undergo randomization into either the pulsed lavage arm (receive mastectomy pocket wash out using pulsed lavage) or the no pulsed lavage arm (pulsed lavage will not be used). Randomization will occur using a random number generator with even numbers resulting in a pulsed lavage washout and odd numbers resulting in no pulsed lavage washout.
The patients will be followed in clinic for a maximum of 3 months to evaluate the surgical site. The two cohorts will be compared at the end of the study to determine whether there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Pulsed Lavage is a surgical technique that cannot be masked from the investigators performing the operation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years of age, inclusive
- •Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy
- •Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document
排除标准
- •< 18 years of age or > 75 years of age
- •Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
研究组 & 干预措施
Pulsed Lavage Washout
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.
干预措施: Pulsed Lavage Washout (Other)
Pulsed Lavage Washout
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.
干预措施: Implant-based breast reconstruction (Procedure)
Pulsed Lavage Washout
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.
干预措施: Bilateral or unilateral mastectomy (Procedure)
Pulsed Lavage Washout
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.
干预措施: Tissue expander (Device)
Pulsed Lavage Washout
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.
干预措施: Acellular dermal matrix (Other)
No Pulsed Lavage
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement.
干预措施: Implant-based breast reconstruction (Procedure)
No Pulsed Lavage
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement.
干预措施: Bilateral or unilateral mastectomy (Procedure)
No Pulsed Lavage
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement.
干预措施: Tissue expander (Device)
No Pulsed Lavage
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement.
干预措施: Acellular dermal matrix (Other)
结局指标
主要结局
Post-op Complications
时间窗: up to 3 months
unintended complications that occur post-surgically
次要结局
未报告次要终点
研究者
Richard Jobe Fix
Professor in the Department of Plastic Surgery
University of Alabama at Birmingham