Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies
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
This study proposes to estimate the effectiveness of prolonged use (7 days) of NPWT in an oncologic setting. We plan to address the following aims: 1) To estimate the effectiveness rate of the NPWT dressing in decreasing wound infection for oncologic gastrointestinal surgical procedures; 2) To evaluate if usage of NPWT is associated with earlier return to intended oncologic therapy (RIOT) after surgical resections for gastrointestinal cancer; and 3) To test the difference in SSI between standard wound therapy versus NPWT in decreasing wound events after oncologic gastrointestinal procedure. We hypothesize use of the negative pressure dressing could decrease the incidence of postoperative infection complication (SSI) and possibly lead to faster initiation of antineoplastic therapy.
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
Scheduled surgical procedure where wound considered dirty
Scheduled surgical procedure for wound left for closure by secondary intention
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
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