NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
Completed · Phase 2/Phase 3
Conditions studied: Surgical Wound Infection
In brief
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
Key facts
- Study ID
- NCT04955730
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 290
- Starts
- 2021-08-05
- Expected to finish
- 2025-09-23
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Moffitt Cancer Center — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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