Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Surgical Site Complications
研究概览
简要总结
The investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. The trial will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.
详细描述
This study is a multicentre, clinical randomized controlled trial comparing the use of incisional negative pressure wound therapy versus standard sterile dressings in high-risk ventral hernia repairs. The trial will be enrolling patients undergoing elective or emergent ventral hernia repair who have risk factors for surgical wound complications and randomizing them to either receive a PREVENA incisional negative pressure wound therapy system dressing for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. The primary outcome will be a composite of a variety of surgical site complications including wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia recurrence, and fistula formation. These will be evaluated by unblinded clinical judgement of treating physicians, and blinded assessment with ultrasonography. Secondary outcomes will include perceived difference in Quality of Life and cost-effectiveness of the intervention.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Given the physical differences in the negative pressure wound therapy systems compared to standard sterile dressings, patient participants and care providers will not be able to be blinded. Ultrasound evaluators and statisticians, however, will be.
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
- •patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter
- •have one or more of the following risk factors for post-operative surgical site complications:
- •Body Mass Index (BMI) greater than or equal to 30
- •diagnosis of diabetes mellitus (either type I or II)
- •previous history of hernia recurrence
- •active smoker
- •presence of colostomy or ileostomy
- •age greater than 64
- •chronic obstructive pulmonary disease
- •chronic kidney disease
- •clinically immunocompromised.
排除标准
- •the abdomen is left open post-operatively, or
- •if the patient has a sensitivity to silver.
研究组 & 干预措施
Negative Pressure Incisional Wound Therapy
A PREVENA™ PEEL & PLACE™ system kit will be applied to the surgical wound and assembled in the operating room following closure by primary intent. The system will be set for a negative pressure of -125mmHg. The dressing will be left in place for 7 days post-operation, during which the patient may be discharged from hospital. The dressing will only be removed or changed if the treating physician has suspicion of one of the complications included in the primary composite outcome or is planning re-intervention on the surgical site.
干预措施: Negative pressure incisional wound therapy (Device)
Standard sterile dressing
A sterile island dressing will be applied to the surgical wound in the operating room following closure by primary intent, which will be removed on post-operative day 2 and left open to air unless there is ongoing discharge.
干预措施: Standard sterile dressing (Device)
结局指标
主要结局
Surgical Site Complications
时间窗: First 3 months post-operatively
Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation.
次要结局
- Quality of life after surgery: survey(3 months post-operatively)
- Cost-effectiveness(3 months post-operatively)