NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
NCT ID: NCT04955730
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2021-08-05
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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.
Negative Pressure Wound Therapy
Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
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.
No interventions assigned to this group
Interventions
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Negative Pressure Wound Therapy
Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jose M Pimiento, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Daniel Anaya, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Related Links
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Moffitt Cancer Center Clinical Trial Search
Other Identifiers
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MCC-20561
Identifier Type: -
Identifier Source: org_study_id
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