NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies (NCT04955730) | Clinical Trial Compass
CompletedPhase 2/3
NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
United States290 participantsStarted 2021-08-05
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested negative pressure wound therapy (NPWT) dressings specifically in patients who had surgery for GI cancers — does that match my situation closely enough that the results might be relevant to my care?
2Since this was a Phase 2/3 trial that has now completed, has the data been published yet, and does it show whether NPWT reduced superficial, deep, or organ/space surgical site infections compared to standard wound dressings?
3Surgical site infections after GI cancer surgery can be serious enough to delay recovery or delay further cancer treatment — based on what this trial found, would you consider using NPWT on my wound after surgery, or is standard dressing still your preference?
4What would a surgical site infection after my GI cancer procedure actually mean for my recovery timeline and next steps in treatment, and does the evidence from this trial change how you'd manage my wound care?
5Are there any added costs, discomfort, or logistical considerations with NPWT dressings that I should weigh against the potential benefit of reduced infection risk shown in trials like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surgical Site Infection - Superficial Incisional
Timeframe: 30 days post operation
2
Surgical Site Infection - Deep Incisional
Timeframe: 30 days post operation
3
Surgical Site Infection - Organ/Space Incisional
Timeframe: 30 days post operation
Trial details
NCT IDNCT04955730
SponsorH. Lee Moffitt Cancer Center and Research Institute