Postoperative Management of Groin Flaps for Vascular Coverage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in AM-PAC Score
研究概览
简要总结
This is a randomized controlled trial designed to analyze the impact of bedrest duration on return to functional independence at discharge following sartorius flap for coverage of vascular reconstruction in the groin.
详细描述
This is a pilot prospective study with the purpose of evaluating the impact of bedrest duration on outcomes of groin muscle flaps used for groin coverage in patients undergoing open, infrainguinal vascular surgery. The investigators plan to target all patients undergoing groin muscle flaps for vascular groin coverage at UCSF.
All patients undergoing groin flaps will be block randomized into two cohorts: Cohort 1 - one day of bedrest (mobilize on post-op day 2) versus Cohort 2 - 5 days of bedrest (mobilize on post-op day 6).
The investigators perform approximately 50 infrainguinal muscle flaps per year. They aim to enroll 30 patients (15 per cohort).
Outcome measures include: surgical complication rates (including wound and lymphatic complications, readmissions, and reoperations), physical function, hospital length of stay, venous thromboembolism (VTE), and rates of discharge to a skilled nursing facility. The investigators will also examine the impact of bedrest on patient reported outcomes one month following surgery. Patient outcomes will be followed for 3 months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The plastic surgeon who performs the sartorius flap does not know which group the patient will be randomized to (early ambulation versus standard 5 days bedrest) until after the surgery is completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing muscle flaps following infrainguinal, open vascular surgery. Patients must be ambulatory at baseline. Patients must be able to provide informed consent.
排除标准
- •Patients who are unable to provide informed consent. Patients are non-ambulatory at baseline. Patients' clinical status is not amenable towards early ambulation. Enrollment is at the discretion of the vascular and plastic surgeons.
- •Bilateral sartorius flaps
研究组 & 干预措施
Early Ambulation Group
The patient will remain on bed rest for one day following surgery and will be encouraged to be out of bed and ambulating on the second day following surgery.
干预措施: Early ambulation (Other)
Standard Group
The patient will remain on bed rest for five days following surgery and will be encouraged to be out of bed and ambulating on the sixth day following surgery.
结局指标
主要结局
Change in AM-PAC Score
时间窗: 1 week
AMPAC Score measures functional status
次要结局
- Wound infection requiring surgery(3 months)
- Length of hospital stay(2 weeks)
- Rehabilitation(3 months)
- Deep wound dehiscence(3 months)
- Wound infection requiring medication(3 months)
- Superficial wound dehiscence(3 months)
- SF36 Score(3 months)
- C-reactive protein(1 week. Depending on the assigned group, this will be either on postoperative day two or six.)
- Albumin(1 week. Depending on the assigned group, this will be either on postoperative day two or six.)
- Pre-albumin(1 week. Depending on the assigned group, this will be either on postoperative day two or six.)