Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Surgical Site Infection - Organ/Space Incisional
研究概览
简要总结
This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators and statisticians will be blinded to treatment randomization. Surgical oncologists will be blinded of treatment randomization until the dressing is applied to the wound.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled surgical procedure for the management of gastrointestinal cancer
- •Scheduled surgical procedure planned for incision that will result in wound >5cm
- •Scheduled surgical procedure planned for skin wound that will be closed by primary intention with either: Staples covered by sterile Telfa® and Tegaderm® or Medipore® OR Dermal or subcuticular sutures covered by Octil®
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Scheduled surgical procedure where wound considered dirty
- •Scheduled surgical procedure for wound left for closure by secondary intention
- •Emergency surgery
- •Pregnancy. Pregnancy status is confirmed per protocol the day of surgery in the preoperative space by urine pregnancy test in patient younger than 65 and with intact uterus. Pregnant patient will be excluded from this study
- •History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems
研究组 & 干预措施
Standard of Care Wound Therapy
Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
NPWT - Negative Pressure Wound Therapy
Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
干预措施: Negative Pressure Wound Therapy (Device)
结局指标
主要结局
Surgical Site Infection - Organ/Space Incisional
时间窗: 30 days post operation
Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Organ/Space Incisions.
Surgical Site Infection - Superficial Incisional
时间窗: 30 days post operation
Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions.
Surgical Site Infection - Deep Incisional
时间窗: 30 days post operation
Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions.
次要结局
- Return to Intended Oncologic Therapy (RIOT)(Up to 12 months after surgery)
- Time to Initiation of Planned Oncologic Therapy(Up to 12 months after surgery)