Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Minor Wound Healing Complications
研究概览
简要总结
Incisional negative pressure therapy (INPWT) has previously been shown in certain patient populations to decrease wound healing complications, decrease the rate of hematomas and seromas, as well as have better scar quality. We have found a group of patients, those who have panniculectomies in preparation for renal transplant, with significantly higher rates of wound healing complications. We believe the best way to demonstrate benefits of incisional negative pressure wound therapy will be in this group of patients known to have significantly higher rates of wound complications.
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
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 panniculectomy in preparation for renal transplantation at the University of California Davis Medical Center. Patients who are entered into the trial and have 30 days of follow up, and those in the INPWT study arm who successfully complete 7 days of treatment, will be included.
排除标准
- •All patients who previously demonstrated a hypersensitivity reaction to adhesives and qualify for panniculectomy in preparation for renal transplantation, or all patients who are undergoing panniculectomy for reasons other than in preparation for renal transplantation (i.e. after massive weight loss or for cosmetic reasons). Patients who do not complete the duration of treatment of negative pressure wound therapy (7 days), or patients who do not follow up for a minimum of 30 days from the date of surgery will be excluded. Adults unable to consent, infants, children, teenagers, pregnant patients and prisoners will be excluded. It is also extremely unlikely, based on our study population, that we will encounter any of these patients.
研究组 & 干预措施
Standard Closure
After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
干预措施: Standard Closure with Skin Glue (Procedure)
Standard Closure
After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
干预措施: Dermabond (Device)
Incisional Negative Pressure Wound Therapy
After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.
干预措施: Incisional Negative Pressure Wound Therapy (Procedure)
Incisional Negative Pressure Wound Therapy
After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.
干预措施: PICO (Smith&Nephew) (Device)
结局指标
主要结局
Minor Wound Healing Complications
时间窗: Up to 3 months after operation
Cellulitis, Seroma, Superficial Wound Separation
Major Wound Healing Complications
时间窗: Up to 3 months after operation
Abscess, Hematoma or any wound complication requiring return to the operating room.
次要结局
- Time to Drain Removal(Up to 3 months after operation)