NPWT in Patients Undergoing Surgical Procedures for Management of GI 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
Conditions:
🦠 Surgical Wound Infection
🗓️ Study Start (Actual) 5 August 2021
🗓️ Primary Completion (Estimated) July 2024
✅ Study Completion (Estimated) July 2025
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Tampa, Florida, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 June 2021
  • First Submitted that Met QC Criteria 7 July 2021
  • First Posted 9 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024