Feasibility of Assessing Wound Perfusion at the Time of Laparotomy Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- percentage of cases with successful perfusion measurements
研究概览
简要总结
This study is being done to find out if Spectrum Near-Infrared (NIR) imaging with Indocyanine Green (ICG) dye can help measure blood flow around an incision before and after the surgeon closes the incision with staples or sutures.
The Spectrum NIR imaging system uses a handheld camera that produces a special type of light that can help surgeons see things during surgery that are difficult to see with the naked eye, for example, cancer tissue versus healthy tissue. Spectrum NIR imaging has been approved by the Food and Drug Administration (FDA) as a tool that is widely used during surgery.
ICG dye is a sterile solution that can be seen with Spectrum NIR imaging. This dye, used with Spectrum NIR imaging, allows surgeons to see blood flow to parts of the body during and after surgery. Making sure that there is enough blood flow to the surgical site helps to promote a less complicated recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Criteria for Eligibility Prior to Surgery
- •Inclusion Criteria:
- •Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK
- •Age ≥18 years
排除标准
- •Women with hepatic dysfunction as evidenced by elevated transaminases
- •Women with a history of cirrhosis or other chronic liver disease
- •Women with an allergy to iodine
- •Women undergoing laparoscopic or minimally invasive surgery
- •Criteria for Eligibility Post-Surgery
- •Inclusion Criteria:
- •Woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the Gynecology Service at MSK
- •Age ≥18 years
- •Subject Exclusion Criteria:
- •Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
- •Women with transverse laparotomy incisions
- •Women with laparotomy incisions left open due to a case classification as "contaminated" or "dirty"
研究组 & 干预措施
Women having a Laparotomy
The first 10 patients enrolled will undergo skin closure with staples. The next 10 patients enrolled will undergo skin closure with a running subcuticular suture.to evaluate skin perfusion using the Spectrum NIR imaging system following intravenous injection of ICG in all patients. Patients will be assigned skin closure with either running subcuticular suture or skin staples in a sequential, nonrandomized fashion before the procedure. After the planned surgical procedure is complete, ICG will be injected intravenously. Video of the incision will be recorded. After skin closure is complete, a second intravenous bolus of ICG (same dose as previously injected) will be given. Video of the incision will again be recorded. Measurement of perfusion will subsequently be performed by video analysis at the previously described three predefined points along the incision after surgery is complete and again after skin closure.
干预措施: Laparotomy (Procedure)
Women having a Laparotomy
The first 10 patients enrolled will undergo skin closure with staples. The next 10 patients enrolled will undergo skin closure with a running subcuticular suture.to evaluate skin perfusion using the Spectrum NIR imaging system following intravenous injection of ICG in all patients. Patients will be assigned skin closure with either running subcuticular suture or skin staples in a sequential, nonrandomized fashion before the procedure. After the planned surgical procedure is complete, ICG will be injected intravenously. Video of the incision will be recorded. After skin closure is complete, a second intravenous bolus of ICG (same dose as previously injected) will be given. Video of the incision will again be recorded. Measurement of perfusion will subsequently be performed by video analysis at the previously described three predefined points along the incision after surgery is complete and again after skin closure.
干预措施: Spectrum NIR imaging system (Other)
Women having a Laparotomy
The first 10 patients enrolled will undergo skin closure with staples. The next 10 patients enrolled will undergo skin closure with a running subcuticular suture.to evaluate skin perfusion using the Spectrum NIR imaging system following intravenous injection of ICG in all patients. Patients will be assigned skin closure with either running subcuticular suture or skin staples in a sequential, nonrandomized fashion before the procedure. After the planned surgical procedure is complete, ICG will be injected intravenously. Video of the incision will be recorded. After skin closure is complete, a second intravenous bolus of ICG (same dose as previously injected) will be given. Video of the incision will again be recorded. Measurement of perfusion will subsequently be performed by video analysis at the previously described three predefined points along the incision after surgery is complete and again after skin closure.
干预措施: ICG (Other)
结局指标
主要结局
percentage of cases with successful perfusion measurements
时间窗: 1 year
Feasibility will be determined by the percentage of cases with successful perfusion measurements.
次要结局
未报告次要终点